At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 103 enrolled
Drug / intervention
Placebo +2 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 Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)
In Brief
A Phase 2 clinical trial evaluating Placebo, Nipocalimab, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 103 participants across 32 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesArgentina, Germany, Hungary, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202420252026
Enrollment StartAug 2023
First PostedSep 2023
Primary CompletionAug 2024
Study CompletionOct 2024
TodayJul 2026
First PostedSep 8, 2023
Enrollment StartAug 15, 2023
Primary CompletionAug 29, 2024
Study CompletionOct 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 2.8 years ago
Interventions
Placebodrug
Placebo will be administered intravenously.
Nipocalimabdrug
Nipocalimab will be administered intravenously.
Certolizumabdrug
Certolizumab will be administered subcutaneously.