At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 252 enrolled
Drug / intervention
Brodalumab +3 moredrug
Likely dose
Methotrexate 7.5 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.
A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
In Brief
A Phase 2 clinical trial evaluating Brodalumab, Placebo, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 252 participants.
Detailed Summary
Study in participants with RA who have an inadequate response to methotrexate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartDec 2009
Primary CompletionFeb 2011
TodayJul 2026
First PostedAug 3, 2009
Enrollment StartDec 30, 2009
Primary CompletionFeb 11, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.9 years ago
Interventions
Brodalumabdrug
3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10
Placebodrug
3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10
Methotrexatedrug
Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.
folic aciddietary
at least 5 mg per week