Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission
Study Details
The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy.
This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.
Protocol Summary
Percentage of Participants with Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy
Timeframe: Week 48
Percentage of Participants with SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy
Timeframe: Week 48
SDAI Score at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in SDAI Score at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in DAS28-ESR at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in DAS28-CRP at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Clinical Disease Activity Index (CDAI) at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in CDAI at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Percentage of Participants With Boolean Remission at All Measured Timepoints
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Percentage of Participants With Disease Worsening
Timeframe: Baseline, Week 12, Week 24, Week 36 and Week 48
Time to Disease Worsening
Timeframe: up to Week 48
Time to Recapture SDAI Remission After Starting Rescue Treatment
Timeframe: Between rescue and remission or Week 48, whichever comes first.
Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48
Timeframe: Week 48