A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration 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 4

Conditions: Arthritis
10023213

Registration Number: NL-OMON31175

Lead Sponsor: Wyeth

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

Main Inclusion Criteria for the Open-Label Period (Period 1):
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.
Main Inclusion Criteria for the Double-Blind Randomized Period (Period 2):
1. Subject has completed the open-label period (period 1) of the study.
2. Subject has a DAS28 *3.2 at week 36 (visit 8) and an average of *3.2 from the week 12 visit (visit 5) through the week 36 visit (visit 8).

Exclusion Criteria

Main Exclusion Criteria for the Open-Label Period (Period 1):
1. Subject has had previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF*) 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 screening.
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.;Main Exclusion Criteria for the Double-Blind Randomized Period (Period 2):
1. Subject has had a dose of an NSAID that has changed within 14 days before the randomization visit (week 36).
2. Subject has had a dose of prednisone >10 mg/day (or equivalent) or dose changed within 14 days before the randomization visit (week 36).
3. Subject has had an oral MTX dose that has changed within 8 weeks before the week 36 randomization visit (with the exception of a hold on the dose due to an adverse event [AE]).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-To compare the efficacy of the combination of etanercept 50 mg once weekly<br /><br>plus MTX with that of MTX monothereapy at week 88 in subjects with moderate RA<br /><br>who have achieved low disease activity after 36-week treatment with open-label<br /><br>etanercept 50 mg once weekly plus MTX.<br /><br>-To compare the efficacy of the combination of etanercept 25 mg once weekly<br /><br>plus MTX with that of MTX monothereapy at week 88 in subjects with moderate RA<br /><br>who have achieved low disease activity after 36-week treatment with open-label<br /><br>etanercept 50 mg once weekly plus MTX.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-To compare the efficacy of etanercept 50 mg once weekly plus MTX with<br /><br>etanercept 25 mg once weekly plus MTX at week 88 in subjects with moderate RA<br /><br>who have achieved low disease activity or remission after 36-week treatment<br /><br>with open-label etanercept 50 mg once weekly plus MTX.<br /><br>-To assess the efficacy of etanercept 50 mg once weekly plus MTX over 36 weeks<br /><br>of the open-label period.<br /><br>-To assess the safety of the treatment regimens over 36 weeks during the<br /><br>open-label period and 52 weeks of the double-blind period.</p><br>