Rheumatoid ArthritisPhase 4NCT01578850
Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
A Phase 4 study testing Etanercept in people with Rheumatoid Arthritis, run by Pfizer at 62 sites in 19 countries.
Trial summary
To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 491 participants
- Where
- 62 sitesin 19 countries
- Study dates
- Jul 2012to Mar 2015
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
- Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.
Who cannot join
- Subjects who used any of the following systemic treatments during the washout periods given below:
- Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
- Treatment with more than 1 NSAID within 14 days at baseline.
- Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
- Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
- Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
- Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
- Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Trial locations and contacts
62 sites in 19 countries.
62 sites in 19 countries
Russia6 sites
LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7(Legal address)
Kazan', 420097
LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7 (Actual address)
Kazan', 420137
Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky
Krasnoyarsk, 660014
Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky,
Krasnoyarsk, 660022
FSBSI "Scientific Research Institute of Rheumatology n. a. V.A. Nasonova"
Moscow, 115522
LLC Institute of Medical Trials (Actual address)
Saint Petersburg, 196084
Philippines5 sites
Angeles University Foundation Medical Center
Angeles City, Pampanga
Chong Hua Hospital, Medical Arts Center
Cebu City, 6000
De La Salle University Health Sciences Campus- Clinical Epidemiology Unit
Dasmariñas, Cavite, 4114
UP-Philippine General Hospital, Medical Research Laboratory, Medicine Department,
Manila, 1000
St. Luke's Mecical Center
Quezon, Manila, 1102
Ukraine5 sites
Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"
Kyiv, 04107
Odessa Regional Clinical Hospital, Outpatient Department
Odesa, 65025
Republican Clinical Hospital, Department of Internal Medicine #2 of Crimean State Medical University
Simferopol, Autonomous Republic of Crimea, 95017
Municipal Institution of Ternopil Regional Council Ternopil University Hospital
Ternopil, 46000
Vinnitsa Regional Clinical Hospital n.a. Pirogov, Department of Faculty Therapy of Vinnitsa NMU
Vinnitsa, 21018
Brazil4 sites
CIP (Centro Internacional de Pesquisa)
Goiânia, Goiás, 74110-120
Research Center
Juiz de Fora
Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia
Salvador, Estado de Bahia, 40050-410
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos LTDA
São Paulo, São Paulo, 04209-003
China4 sites
Chinese Academy of Medical Sciences - Peking Union Medical C
Beijing, 100050
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Shanghai Changning District Guanghua Hospital of Traditional Chinese and Western Medicine
Shanghai, 200052
Shanghai Changhai Hospital[Rheumatology &Immunology]
Shanghai, 200433
Czechia4 sites
Revmatologicka poradna III. Interni nefrologicka, revmatologicka a endokrinologicka klinika
Olomouc, Czech Republic, 775 20
Revmatologicky ustav
Prague, Czech Republic, 12850
Revmatologicka ambulance
Prague, Czech Republic, 150 06
PV-Medical s.r.o.
Zlín, Czech Republic, 760 01
Mexico4 sites
Centro de Investigación y Atención Integral de Durango, SC
Durango, Durango / Mexico, 34080
Centro Medico Las Americas
Mérida, Yucatán
Centro de Alta Especialidad en Reumatología e Investigación
San Luis de Potosi, San Luis Potosí / Mexico, 78213
Hospital Central
San Luis Potosí City, 78290
Romania4 sites
Spitalul Judetean
Baia Mare, Maramure, 4800
Spitalul Clinic Judetean de Urgenta Brasov
Brasov, Brașov County, 500365
Spitalul Clinic de Recuperare
Iași, Iaşi, 700656
Spitalul Clinic Judetean de Urgenta Targu Mures
Tg Mures, 540136
Taiwan4 sites
Buddhist Tzu Chi General Hospital - Dalin Branch
Chiayi City, 62247
Cathay General Hospital
Dawan, Taoyuan, 330
China Medical University Hospital, Division of Rheumatology, Allergy and Immunology
Taichung, 404
Taipei Medical University Hospital
Taipei, 11042
Thailand4 sites
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,
Amphoe Mueang, Chiang Mai, 50200
Siriraj Hospital [Rheumatology]
Bangkok, 10700
Khon Kaen University (KKU) - Faculty of Medicine
Khon Kaen, 40002
Songklanagarind Hospital
Songkhla, 90110
Colombia3 sites
Centro Integral de reumatolo[Gerencia / Representante Legal]
Barranquilla, Atlántico, 99999
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota DC, Cundinamarca
Hospital Pablo Tobon Uribe (HPTU)
Santa Fe de Antioquia, Antioquia
Egypt3 sites
New University Hospital, Alexandria Clinical Research Center
Alexandria, Alexandria Governorate, 21131
Al Azhar University Hospital [Rheumatology]
Cairo, Cairo Governorate, 12111
Ain Shams University/Al Demerdash Hospital/Diabetology Unit
Cairo
Malaysia3 sites
Queen Elizabeth Hospital
Kota Kinabalu, Sabah, 88586
University Malaysia Medical Centre
Kuala Lumpur, 59100
Hopsital Putrajaya [Medicine]
Putrajaya, Putrajaya, 62250
South Africa3 sites
Universitas Hospital [Cardiololgy]
Bloemfontein, Free State, 9301
Vincent Pallotti Hospital
Cape Town, 7405
Winelands Medical Research Centre
Stellenbosch, 7600
Hungary2 sites
Budai Irgalmasrendi Korhaz
Budapest, 1023
Magyar Honvédség Egészségügyi Központ
Budapest, 1062
Jordan1 site
Pharmaceutical Research Center- PRC. Jordan University of Science and Technology
Irbid, 22110
Lebanon1 site
American University of Beirut Medical Center
Beirut, Lebanon, 1107-2020
About this study
Official title: A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)
To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept, placebo
- Keywords
- rheumatoid arthritis, etanercept, methotrexate, DMARDs
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
etanercept 50mg once weekly + methotrexate with or without other DMARDs
placeboDrug
etanercept placebo once weekly + methotrexate with or without other DMARDs
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: Etanercept |
| Group B | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.
Proportion of participants who remained in LDA DAS28-ESR <3.2 at Week 52 is presented below.
Measured: Baseline and Week 52
Secondary outcomes (28)
Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)
Proportion of participants who remained in Remission (DAS28-ESR <2.6) at Week 52.
Measured: Baseline and Week 52
Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1
Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.
Measured: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2
Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1
Proportion of participants who achieved remission (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.
Measured: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2
Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1
The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.
Measured: Baseline, Weeks 4, 8, 16 and 24
Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2
The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 2. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria
Flare is defined as the criteria of loss of LDA plus ≥0.6 unit worsening in DAS28-ESR score during period 2.
Measured: Baseline and Week 52
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.
EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.
Measured: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.
EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.
SDAI and CDAI are defined as:
- SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1.
Measured: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.
SDAI and CDAI are defined as:
- SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Change of CDAI and SDAI at Each Visit During Period 1.
SDAI and CDAI are defined as:
- SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1.
Measured: Baseline, Weeks 4, 8, 16 and 24
Change of CDAI and SDAI at Each Visit During Period 2
SDAI and CDAI are defined as:
- SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.
A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.
Measured: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.
A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).
A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.
Measured: Baseline, Weeks 4, 8, 16 and 24
Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).
A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1
The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'.
Measured: Baseline, Weeks 4, 8, 16 and 24
Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2
The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Change in the Subject Global Assessment of Arthritis in Period 1
Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.
Measured: Baseline, Weeks 4, 8, 16 and 24
Change in the Subject Global Assessment of Arthritis in Period 2
Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1
Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.
Measured: Baseline, Weeks 4, 8, 16 and 24
Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2
Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1
Participants were asked to answer the question "In general how would you rate your health over the last 2 3 weeks?" by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Measured: Baseline, Weeks 4, 8, 16 and 24
Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2
Participants were asked to answer the question "In general how would you rate your health over the last 2-3 weeks?" by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Change in CRP and ESR at Each Visit During Period 1
The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.
Measured: Baseline, Weeks 4, 8, 16 and 24
Change in CRP and ESR at Each Visit During Period 2
The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.
Measured: Baseline, Weeks 24, 28, 36, 44 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2015
- Study completionMar 2015
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- 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
- NCT01578850
- Sponsor's protocol ID
- B1801315
- Other IDs
- 2011-005448-87, B1801315
- Status last verified
- May 2016
- First submitted
- 12 Apr 2012
- Last updated
- 6 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.
PubMed 31277720Zerbini CAF, Abud-Mendoza C, Mendez-Patarroyo P, De Angelo Andrade M, Pedersen R, Vlahos B, Borlenghi CE. Maintenance of low disease activity and remission with etanercept-disease-modifying antirheumatic drug (DMARD) combination therapy compared with treatment with DMARDs alone in Latin American patients with active rheumatoid arthritis: Subset analysis of a randomized trial. Medicine (Baltimore). 2018 Sep;97(36):e11989. doi: 10.1097/MD.0000000000011989.
PubMed 30200078Pavelka K, Akkoc N, Al-Maini M, Zerbini CAF, Karateev DE, Nasonov EL, Rahman MU, Pedersen R, Dinh A, Shen Q, Vasilescu R, Kotak S, Mahgoub E, Vlahos B. Maintenance of remission with combination etanercept-DMARD therapy versus DMARDs alone in active rheumatoid arthritis: results of an international treat-to-target study conducted in regions with limited biologic access. Rheumatol Int. 2017 Sep;37(9):1469-1479. doi: 10.1007/s00296-017-3749-7. Epub 2017 Jun 9.
PubMed 28597306
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)
- ClinicalTrials.gov ID
- NCT01578850
- Acronym / sponsor ID
- B1801315
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, etanercept, methotrexate, DMARDs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Apr 2012 (estimated)
- Results
- Posted 6 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Etanercept |
| Group B | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
- Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.
Key exclusion criteria (8 listed)
- Subjects who used any of the following systemic treatments during the washout periods given below:
- Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
- Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
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 |
|---|---|---|
| Etanerceptetanercept 50mg once weekly + methotrexate with or without other DMARDs | Drug | Group A |
| placeboetanercept placebo once weekly + methotrexate with or without other DMARDs | Drug | Group B |
Primary outcome
Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.
Time frame: Baseline and Week 52
Proportion of participants who remained in LDA DAS28-ESR <3.2 at Week 52 is presented below.
28 secondary outcomes
Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)
Time frame: Baseline and Week 52
Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1
Time frame: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1
Time frame: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1
Time frame: Baseline, Weeks 4, 8, 16 and 24
Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria
Time frame: Baseline and Week 52
Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.
Time frame: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.
Time frame: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Change of CDAI and SDAI at Each Visit During Period 1.
Time frame: Baseline, Weeks 4, 8, 16 and 24
Change of CDAI and SDAI at Each Visit During Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.
Time frame: Baseline, Weeks 4, 8, 16 and 24
Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).
Time frame: Baseline, Weeks 4, 8, 16 and 24
Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1
Time frame: Baseline, Weeks 4, 8, 16 and 24
Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Change in the Subject Global Assessment of Arthritis in Period 1
Time frame: Baseline, Weeks 4, 8, 16 and 24
Change in the Subject Global Assessment of Arthritis in Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1
Time frame: Baseline, Weeks 4, 8, 16 and 24
Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1
Time frame: Baseline, Weeks 4, 8, 16 and 24
Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Change in CRP and ESR at Each Visit During Period 1
Time frame: Baseline, Weeks 4, 8, 16 and 24
Change in CRP and ESR at Each Visit During Period 2
Time frame: Baseline, Weeks 24, 28, 36, 44 and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31277720Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.
- Derived from this study: PubMed 30200078Zerbini CAF, Abud-Mendoza C, Mendez-Patarroyo P, De Angelo Andrade M, Pedersen R, Vlahos B, Borlenghi CE. Maintenance of low disease activity and remission with etanercept-disease-modifying antirheumatic drug (DMARD) combination therapy compared with treatment with DMARDs alone in Latin American patients with active rheumatoid arthritis: Subset analysis of a randomized trial. Medicine (Baltimore). 2018 Sep;97(36):e11989. doi: 10.1097/MD.0000000000011989.
- Derived from this study: PubMed 28597306Pavelka K, Akkoc N, Al-Maini M, Zerbini CAF, Karateev DE, Nasonov EL, Rahman MU, Pedersen R, Dinh A, Shen Q, Vasilescu R, Kotak S, Mahgoub E, Vlahos B. Maintenance of remission with combination etanercept-DMARD therapy versus DMARDs alone in active rheumatoid arthritis: results of an international treat-to-target study conducted in regions with limited biologic access. Rheumatol Int. 2017 Sep;37(9):1469-1479. doi: 10.1007/s00296-017-3749-7. Epub 2017 Jun 9.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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
62 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept in people with Rheumatoid Arthritis, run by Pfizer at 62 sites in 19 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 2 inclusion and 8 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Russia, Philippines, Ukraine, Brazil, China and 14 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Jul 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?
Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52. (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01578850, which also lists 3 linked publications.
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 6 Jul 2016.