CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 491 enrolled
Drug / intervention
Etanercept +1 moredrug
Likely dose
Etanercept 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01578850
NCT01578850Phase 4Completed

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)

Pfizer·interventional·Posted Apr 17, 2012·Updated Jul 6, 2016

In Brief

A Phase 4 clinical trial evaluating Etanercept and placebo for Rheumatoid Arthritis. Completed, enrolled 491 participants across 62 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, China, Colombia, Czechia, Egypt, Hungary, Jordan, Lebanon, Malaysia, Mexico, Philippines, Qatar, Romania, Russia, South Africa, Taiwan, Thailand, Ukraine, United Arab Emirates
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2012
Enrollment StartJul 1, 2012
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.2 years ago

Interventions

Etanerceptdrug

etanercept 50mg once weekly + methotrexate with or without other DMARDs

placebodrug

etanercept placebo once weekly + methotrexate with or without other DMARDs