Rheumatoid ArthritisPhase 2NCT00650767
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
A Phase 2 study testing ARRY-438162, MEK inhibitor; oral in people with Rheumatoid Arthritis, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 35 sites in 7 countries.
Trial summary
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- ARRY-438162, MEK inhibitor; oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 35 sitesin 7 countries
- Study dates
- Mar 2008to Jul 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
- Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
- Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
- No prior use of biological agents for the treatment of rheumatoid arthritis.
- Additional criteria exist.
Who cannot join
- Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
- A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
- Additional criteria exist.
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
Brazil7 sites
CETI - Hospital das Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, 80060
Médicos Unidos Ltda.
Goiânia, Goiás, 74110-120
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
Hospital São Lucas da da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital São Paulo / Instituto Paulista de Reumatologia
São Paulo, São Paulo, 04026-000
Hospital Heliópolis
São Paulo, São Paulo, 04230-000
Instituto de Medicina Avançada (IMA Brasil)
São Paulo, São Paulo, 05437-010
Hungary7 sites
Budai Irgalmasrendi Kórház - Allergólógia és Immunológia
Budapest
Synexus Ltd Hungary
Budapest
Békés Megyei Pándy Kálmán Kórház - Rheumatology
Gyula
Mozgasszervi Rehabilitacios Kozpont
Mezőkövesd
Fejér Megyei Szent György Kórház - Rheumatology
Székesfehérvár
MÁV Kórház - Clinical Pharmacology
Szolnok
Vas Megyei Markusovszky Korhaz Lajos Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház, Zártkörűen Működő Nonprofit Részvénytársaság - Rheumatology
Szombathely
Argentina6 sites
Asistencia Integral en Reumatologia
Buenos Aires
CEMIC
Buenos Aires
Hospital Britanico
Buenos Aires
CER San Juan
San Juan
Centro Medico Privado de Reumatologia
San Miguel de Tucumán
Centro de Investigaciones Clinicas del Litoral SRL
Santa Fe
Poland6 sites
Centrum Osteoporozy i Chorób Kostno-Stawowych
Bialystok
Wojewódzki Szpital Zespolony - Oddział Reumatologiczny
Elblag
Centrum Leczenia Chorob Cywilizacyjnych
Gdynia
NZOZ Reumed
Lublin
Centrum Leczenia Chorob Cywilizacyjnych
Warsaw
Synexus SCM Sp. z o.o.
Wroclaw
Peru4 sites
Instituto de Investigacion y Seguridad Medica EIRL
Arequipa
Clinica San Felipe - Centro de Estudios Clinicos CGYM
Lima
Clínica Ricardo Palma- Sitio de Investigacion de Reumatologia
Lima
Hospital Maria Auxiliadora - Centro de Investigaciones Medicas
Lima
Romania4 sites
Spitalul Clinic "Sf, Maria"
Bucharest
Spitalul Clinic Judetean de Urgenta
Cluj-Napoca
Spitalul Clinic Judetean de Urgenta
Târgu Mureş
Cabinet Medical "Prof. Dr. Miorara Banciu"
Timișoara
United States1 site
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ARRY-438162, MEK inhibitor; oral, Placebo; oral
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-438162, MEK inhibitor; oralDrug
multiple dose, single schedule
Placebo; oralDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| ARRY-438162 (Schedule 1) | Experimental | Not described Receives: Drug: ARRY-438162, MEK inhibitor; oral |
| ARRY-438162 (Schedule 2) | Experimental | Not described Receives: Drug: ARRY-438162, MEK inhibitor; oral |
| ARRY-438162 (Schedule 3) | Experimental | Not described Receives: Drug: ARRY-438162, MEK inhibitor; oral |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20% (ACR20) Response Rate at Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Measured: Week 12
Secondary outcomes (123)
American College of Rheumatology 20% (ACR20) Response Rate at Week 1
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Measured: Week 1
American College of Rheumatology 20% (ACR20) Response Rate at Week 2
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Measured: Week 2
American College of Rheumatology 20% (ACR20) Response Rate at Week 4
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Measured: Week 4
American College of Rheumatology 20% (ACR20) Response Rate at Week 8
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Measured: Week 8
American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
Measured: Week 16 (Follow-up)
American College of Rheumatology 50% (ACR50) Response Rate at Week 1
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Measured: Week 1
American College of Rheumatology 50% (ACR50) Response Rate at Week 2
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Measured: Week 2
American College of Rheumatology 50% (ACR50) Response Rate at Week 4
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Measured: Week 4
American College of Rheumatology 50% (ACR50) Response Rate at Week 8
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Measured: Week 8
American College of Rheumatology 50% (ACR50) Response Rate at Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Measured: Week 12
American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 50 has a positive outcome if 50% improvement in tender or swollen joint counts were achieved as well as a 50% improvement in at least three of the other five criteria.
Measured: Week 16 (Follow-up)
American College of Rheumatology 70% (ACR70) Response Rate at Week 1
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Measured: Week 1
American College of Rheumatology 70% (ACR70) Response Rate at Week 2
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Measured: Week 2
American College of Rheumatology 70% (ACR70) Response Rate at Week 4
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Measured: Week 4
American College of Rheumatology 70% (ACR70) Response Rate at Week 8
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Measured: Week 8
American College of Rheumatology 70% (ACR70) Response Rate at Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Measured: Week 12
American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The ACR 70 has a positive outcome if 70% improvement in tender or swollen joint counts were achieved as well as a 70% improvement in at least three of the other five criteria.
Measured: Week 16 (Follow-up)
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Measured: Baseline
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Measured: Week 1
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Measured: Week 2
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Measured: Week 4
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Measured: Week 8
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Measured: Week 12
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
Tender joint count is calculated based on the tenderness response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint tenderness.
Measured: Week 16 (Follow-up)
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Measured: Baseline
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Measured: Week 1
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Measured: Week 2
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Measured: Week 4
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Measured: Week 8
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Measured: Week 12
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis.
The swollen joint count was calculated based on the swelling response of 28 joints. Possible values ranged from 0 to 28. A lower score indicated less joint swelling.
Measured: Week 16 (Follow-up)
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Measured: Baseline
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Measured: Week 1
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Measured: Week 2
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Measured: Week 4
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Measured: Week 8
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Measured: Week 12
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
The Patient's Assessment of Pain utilized a 0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain.
Measured: Week 16 (Follow-up)
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Measured: Baseline
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Measured: Week 1
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Measured: Week 2
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Measured: Week 4
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Measured: Week 8
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Measured: Week 12
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Patient's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Physician's Global Assessment of Arthritis. The patient self-assessed how the arthritis affected their lives at the time of the visit using the visual analog scale (VAS).
Patients answered the following: "Considering all the ways in which illness and health conditions may affect you at this time, please make a mark below to show how you are doing." The patient's response was recorded using the 100 mm visual analog scale between 0 (Very Well) and 100 (Very Poorly).
Measured: Week 16 (Follow-up)
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Measured: Baseline
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Measured: Week 1
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Measured: Week 2
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Measured: Week 4
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Measured: Week 8
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Measured: Week 12
Physician's Global Assessment of Arthritis - Visual Analog Score (VAS)
The Physician's Global Assessment of Arthritis was an evaluation based on the patient's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The Investigator assessed how the overall arthritis appeared at the time of the visit using the visual analog scale (VAS).
The physician's response was recorded using the 100 mm visual analog scale between 0 (Very Good) and 100 (Very Bad).
Measured: Week 16 (Follow-up)
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Measured: Baseline
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Measured: Week 1
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Measured: Week 2
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Measured: Week 4
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Measured: Week 8
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Measured: Week 12
Health Assessment Questionnaire - Disability Index (HAQ-DI)
The HAQ-DI contains a list of items that assessed the degree of difficulty experienced in 8 categories of daily living activities (included in 20 questions) over the past week: Dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consists of 2 or 3 items. For each question in the HAQ-DI, the level of difficulty was scored from 0 to 3 with 0 equal to "without difficulty," 1 equal to "with some difficulty," 2 equal to "with much difficulty" and 3 equal to "unable to do." Any activity that required assistance from another individual or required the use of an assistive device adjusted to a minimum score of 2 to represent a more limited functional status.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Measured: Week 16 (Follow-up)
C-Reactive Protein (CRP) at Baseline
Measured: Baseline
C-Reactive Protein (CRP) at Week 1
Measured: Week 1
C-Reactive Protein (CRP) at Week 2
Measured: Week 2
C-Reactive Protein (CRP) at Week 4
Measured: Week 4
C-Reactive Protein (CRP) at Week 8
Measured: Week 8
C-Reactive Protein (CRP) at Week 12
Measured: Week 12
C-Reactive Protein (CRP) at Week 16 (Follow-up)
Measured: Week 16 (Follow-up)
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Measured: Baseline
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Measured: Week 1
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Measured: Week 2
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Measured: Week 4
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Measured: Week 8
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Measured: Week 12
Disease Activity Score (DAS) Using C-Reactive Protein (DAS28-4[CRP])
The DAS28-4(CRP) score is a measure of the subject's disease activity. DAS28-4(CRP) is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity and CRP. DAS28 provides a number on a scale (0 to 10) indicating current disease activity. A score above 5.1 means high disease activity and a score below 3.2 indicates low disease activity.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Physical
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Bodily Pain
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - General Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Vitality
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Social Functioning
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Role-Emotional
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures.
The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
SF-36V2 is a generic 36-item generic health status measure covering 2 summary measures: physical component summary (PCS) and mental health component score (MCS); it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst) to 100 (best).
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Mental Health Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Week 16 (Follow-up)
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Baseline
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Week 4
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Week 8
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Week 12
SF-36 Health Questionnaire - Version 2 (SF-36v2) - Physical Component Score
The SF-36v2 (Acute version) is a 36-item generic health status measure that yields an 8-scale profile of functional health and well-being as well as psychometrically-based physical and mental health summary measures. The SF-36v2 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability, while the higher the score the less disability. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Summary statistics were calculated for each of the 8 scales, the 2 summary measures, and changes from baseline for each treatment group.
Measured: Week 16 (Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650767
- Sponsor's protocol ID
- ARRAY-162-201
- Status last verified
- Nov 2020
- First submitted
- 31 Mar 2008
- Last updated
- 1 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ARRY-438162 in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00650767
- Acronym / sponsor ID
- ARRAY-162-201
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Posted 7 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ARRY-438162 (Schedule 1) | Experimental | Drug: ARRY-438162, MEK inhibitor; oral |
| ARRY-438162 (Schedule 2) | Experimental | Drug: ARRY-438162, MEK inhibitor; oral |
| ARRY-438162 (Schedule 3) | Experimental | Drug: ARRY-438162, MEK inhibitor; oral |
| Placebo | Placebo comparator | Drug: Placebo; oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
- Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
- Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
- No prior use of biological agents for the treatment of rheumatoid arthritis.
- Additional criteria exist.
Key exclusion criteria (3 listed)
- Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
- A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
- Additional criteria exist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARRY-438162, MEK inhibitor; oralmultiple dose, single schedule | Drug | ARRY-438162 (Schedule 1), ARRY-438162 (Schedule 2), ARRY-438162 (Schedule 3) |
| Placebo; oralmatching placebo | Drug | Placebo |
Primary outcome
American College of Rheumatology 20% (ACR20) Response Rate at Week 12
Time frame: Week 12
The ACR (American College of Rheumatology) Criteria is a standard criteria to measure the effectiveness of various arthritis medications or treatments in clinical trials for Rheumatoid Arthritis. The ACR 20 has a positive outcome if 20% improvement in tender or swollen joint counts were achieved as well as a 20% improvement in at least three of the other five criteria.
123 secondary outcomes
American College of Rheumatology 20% (ACR20) Response Rate at Week 1
Time frame: Week 1
American College of Rheumatology 20% (ACR20) Response Rate at Week 2
Time frame: Week 2
American College of Rheumatology 20% (ACR20) Response Rate at Week 4
Time frame: Week 4
American College of Rheumatology 20% (ACR20) Response Rate at Week 8
Time frame: Week 8
American College of Rheumatology 20% (ACR20) Response Rate at Week 16 (Follow-up)
Time frame: Week 16 (Follow-up)
American College of Rheumatology 50% (ACR50) Response Rate at Week 1
Time frame: Week 1
American College of Rheumatology 50% (ACR50) Response Rate at Week 2
Time frame: Week 2
American College of Rheumatology 50% (ACR50) Response Rate at Week 4
Time frame: Week 4
American College of Rheumatology 50% (ACR50) Response Rate at Week 8
Time frame: Week 8
American College of Rheumatology 50% (ACR50) Response Rate at Week 12
Time frame: Week 12
American College of Rheumatology 50% (ACR50) Response Rate at Week 16 (Follow-up)
Time frame: Week 16 (Follow-up)
American College of Rheumatology 70% (ACR70) Response Rate at Week 1
Time frame: Week 1
American College of Rheumatology 70% (ACR70) Response Rate at Week 2
Time frame: Week 2
American College of Rheumatology 70% (ACR70) Response Rate at Week 4
Time frame: Week 4
American College of Rheumatology 70% (ACR70) Response Rate at Week 8
Time frame: Week 8
American College of Rheumatology 70% (ACR70) Response Rate at Week 12
Time frame: Week 12
American College of Rheumatology 70% (ACR70) Response Rate at Week 16 (Follow-up)
Time frame: Week 16 (Follow-up)
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time frame: Baseline
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time frame: Week 1
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time frame: Week 2
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time frame: Week 4
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time frame: Week 8
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time frame: Week 12
American College of Rheumatology (ACR) Response Criteria - Tender Joint Count (28)
Time frame: Week 16 (Follow-up)
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time frame: Baseline
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time frame: Week 1
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time frame: Week 2
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time frame: Week 4
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time frame: Week 8
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time frame: Week 12
American College of Rheumatology (ACR) Response Criteria - Swollen Joint Count (28)
Time frame: Week 16 (Follow-up)
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time frame: Baseline
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time frame: Week 1
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time frame: Week 2
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time frame: Week 4
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time frame: Week 8
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time frame: Week 12
Patient's Assessment of Arthritis Pain - Visual Analog Scale (VAS)
Time frame: Week 16 (Follow-up)
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time frame: Baseline
Patient's Global Assessment of Arthritis - Visual Analog Score (VAS)
Time frame: Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARRY-438162, MEK inhibitor; oral in people with Rheumatoid Arthritis, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 35 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Brazil, Hungary, Argentina, Poland, Peru and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology 20% (ACR20) Response Rate at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.