CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 215 enrolled
Drug / intervention
Golimumab 50 mg +1 morebiological
Likely dose
Golimumab 50 mgfrom 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/NCT01715896
NCT01715896Phase 2Completed
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A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

MedImmune LLC·interventional·Posted Oct 29, 2012·Updated Oct 31, 2016

In Brief

A Phase 2 clinical trial evaluating Golimumab 50 mg and Mavrilimumab 100 mg for Rheumatoid Arthritis. Completed, enrolled 215 participants across 39 sites in 14 countries.

Detailed Summary

The primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor (TNF) agents (excluding golimumab) for efficacy or safety reasons.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Colombia, Czechia, France, Greece, Hungary, Israel, Mexico, Portugal, Russia, Serbia, Slovakia, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2012
Enrollment StartMar 1, 2013
Primary CompletionNov 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.7 years ago

Interventions

Golimumab 50 mgbiological

Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.

Mavrilimumab 100 mgbiological

Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.