A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-WeeklyAdministration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate

Phase 1

• Conditions: Rheumatoid arthritis

• Registration Number: EUCTR2007-000896-41-BE
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. A Pfizer Company,Philadelphia,PA-19101,USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Subject has a diagnosis of RA based on the 1987 American College of Rheumatology (ACR) Revised Criteria for RA.
2. Subject is currently receiving an optimal dose of oral MTX once weekly for the treatment of RA, in the opinion of the investigator, but at least 15 mg/week but no more than 25 mg/week and at a stable dose for a minimum of 8 weeks at screening.
3. Subject has moderate RA disease activity, as defined by a DAS28 >3.2 and =5.1 at both the screening and baseline visits.
4. Subject has a functional status of class I, II, or III as defined by the ACR Revised Criteria.
5. Subject is 18 to 70 years of age at the time of consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has had previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF-a) inhibitors, or other biologic agents.
2. Subject has received any DMARD, other than MTX, within 28 days before baseline.
3. Subject has had concurrent treatment with more than 1 NSAID at baseline.
4. Subject has had a dose of an NSAID that has changed within 14 days before screening.
5. Subject has had a dose of prednisone >10 mg/day (or equivalent) or has had a dose changed within 14 days before screening.
6. Subject has received an intra-articular, intravenous, intramuscular, or subcutaneous (SC) corticosteroid within 28 days before screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified