At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 108 enrolled
Drug / intervention
Namilumab +3 moredrug
Likely dose
Not stated in 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.
A 24-Week Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study to Evaluate the Efficacy and Safety of 3 Doses of Namilumab (20 mg, 80 mg and 150 mg) in Combination With Methotrexate (MTX) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
In Brief
A Phase 2 clinical trial evaluating Namilumab, Placebo, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 108 participants across 31 sites in 8 countries.
Detailed Summary
The purpose of this study is to establish proof of concept and identify the optimal efficacious dose for namilumab in RA in patients with an inadequate response to methotrexate (MTX-IR) and in patients with an inadequate response to one tumor necrosis factor (TNF)-inhibitor (TNF-IR).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Czechia, Japan, Poland, Russia, South Korea, Spain, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedMar 2015
Primary CompletionMay 2016
Study CompletionDec 2016
TodayJul 2026
First PostedMar 4, 2015
Enrollment StartDec 17, 2014
Primary CompletionMay 11, 2016
Study CompletionDec 5, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.3 years ago
Interventions
Namilumabdrug
Namilumab subcutaneous injection
Placebodrug
Namilumab placebo-matching subcutaneous injection
Methotrexatedrug
Methotrexate tablets
Folic/folinic aciddrug
Folic/folinic acid tablets