CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 420 enrolled
Drug / intervention
Mavrilimumab 30 mg +3 morebiological
Likely dose
Mavrilimumab 30 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/NCT01706926
NCT01706926Phase 2Completed
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A Phase 2b Study to Evaluate the Efficacy and Safety of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

MedImmune LLC·interventional·Posted Oct 15, 2012·Updated Sep 27, 2016

In Brief

A Phase 2 clinical trial evaluating Mavrilimumab 30 mg, Mavrilimumab 100 mg, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 420 participants across 42 sites in 14 countries.

Detailed Summary

The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Bulgaria, Chile, Colombia, Czechia, Estonia, Germany, Hungary, Poland, Russia, Serbia, South Africa, Spain, Ukraine
CollaboratorsMedImmune Ltd

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.7 years ago

Interventions

Mavrilimumab 30 mgbiological

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks

Mavrilimumab 100 mgbiological

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.

Mavrilimumab 150 mgbiological

Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.

Placeboother

Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.