AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Brazil

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

Other trials in Hungary

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

Other trials in Argentina

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

Other trials in Poland

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

Other trials in Peru

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

Other trials in Romania

United States1 site
  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

Other trials in United States

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.

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 groups in NCT00650767
Study groupRoleWhat they receive
ARRY-438162 (Schedule 1)ExperimentalNot described
Receives: Drug: ARRY-438162, MEK inhibitor; oral
ARRY-438162 (Schedule 2)ExperimentalNot described
Receives: Drug: ARRY-438162, MEK inhibitor; oral
ARRY-438162 (Schedule 3)ExperimentalNot described
Receives: Drug: ARRY-438162, MEK inhibitor; oral
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo; oral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  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

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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)

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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)

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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)

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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)

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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)

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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)

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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)

  60. C-Reactive Protein (CRP) at Baseline

    Measured: Baseline

  61. C-Reactive Protein (CRP) at Week 1

    Measured: Week 1

  62. C-Reactive Protein (CRP) at Week 2

    Measured: Week 2

  63. C-Reactive Protein (CRP) at Week 4

    Measured: Week 4

  64. C-Reactive Protein (CRP) at Week 8

    Measured: Week 8

  65. C-Reactive Protein (CRP) at Week 12

    Measured: Week 12

  66. C-Reactive Protein (CRP) at Week 16 (Follow-up)

    Measured: Week 16 (Follow-up)

  67. 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

  68. 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

  69. 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

  70. 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

  71. 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

  72. 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

  73. 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)

  74. 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

  75. 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

  76. 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

  77. 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

  78. 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)

  79. 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

  80. 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

  81. 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

  82. 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

  83. 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)

  84. 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

  85. 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

  86. 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

  87. 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

  88. 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)

  89. 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

  90. 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

  91. 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

  92. 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

  93. 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)

  94. 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

  95. 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

  96. 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

  97. 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

  98. 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)

  99. 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

  100. 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

  101. 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

  102. 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

  103. 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)

  104. 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

  105. 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

  106. 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

  107. 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

  108. 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)

  109. 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

  110. 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

  111. 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

  112. 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

  113. 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)

  114. 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

  115. 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

  116. 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

  117. 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

  118. 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)

  119. 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

  120. 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

  121. 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

  122. 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

  123. 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.

  1. First posted2 Apr 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

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)
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
Data monitoring committee
Yes

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in