At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 467 enrolled
Drug / intervention
ABP 501biological
Likely dose
ABP 501 40 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.
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating ABP 501 for Arthritis, Rheumatoid. Completed, enrolled 467 participants across 77 sites in 11 countries.
Detailed Summary
The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesBulgaria, Canada, Czechia, Germany, Hungary, Poland, Romania, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionApr 2016
TodayJul 2026
First PostedApr 15, 2014
Enrollment StartApr 1, 2014
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.2 years ago
Interventions
ABP 501biological
Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501