Study Complete
Sponsor ID
20110186

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

Sponsor ID
20110186
Clinicaltrials.gov ID
NCT02373813
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
etanercept
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
371
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of Participants with Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy

Timeframe: Week 48

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Research Site
Victorville, CA, United States, 92395
Status
Recruiting
Location
Research Site
Tustin, CA, United States, 92780
Status
Completed
Location
Research Site
Birmingham, AL, United States, 35205
Status
Completed
Location
Research Site
Grand Rapids, MI, United States, 49546
Status
Completed
Location
Research Site
Hamilton, ON, Canada, L8N 1Y2
Status
Completed
Location
Research Site
Jackson, TN, United States, 38305
Status
Recruiting
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