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COMPLETEDPHASE4

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 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)

NCT01578850•Pfizer

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
•2. 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.

Exclusion Criteria

•1. Subjects who used any of the following systemic treatments during the washout periods given below:
•1. Oral corticosteroid dose of prednisone \>7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
•2. Treatment with more than 1 NSAID within 14 days at baseline.
•3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
•4. 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.
•5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
•2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
•3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

Locations (62)

Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia

Salvador, Estado de Bahia, Brazil

CIP (Centro Internacional de Pesquisa)

Goiânia, Goiás, Brazil

CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos LTDA

São Paulo, São Paulo, Brazil

Research Center

Juiz de Fora, Brazil

Guangdong General Hospital

Guangzhou, Guangdong, China

Chinese Academy of Medical Sciences - Peking Union Medical C

Beijing, China

Shanghai Changning District Guanghua Hospital of Traditional Chinese and Western Medicine

Shanghai, China

Shanghai Changhai Hospital[Rheumatology &Immunology]

Shanghai, China

Hospital Pablo Tobon Uribe (HPTU)

Santa Fe de Antioquia, Antioquia, Colombia

Centro Integral de reumatolo[Gerencia / Representante Legal]

Barranquilla, Atlántico, Colombia

Key Dates

Start Date

July 1, 2012

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

July 6, 2016

Enrollment

491

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

Etanercept

DRUG

placebo

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 6, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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