Trials / Completed
CompletedNCT06028438
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo will be administered intravenously. |
| DRUG | Nipocalimab | Nipocalimab will be administered intravenously. |
| DRUG | Certolizumab | Certolizumab will be administered subcutaneously. |
Timeline
- Start date
- 2023-08-15
- Primary completion
- 2024-08-29
- Completion
- 2024-10-29
- First posted
- 2023-09-08
- Last updated
- 2025-10-16
- Results posted
- 2025-10-16
Locations
32 sites across 6 countries: United States, Argentina, Germany, Hungary, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06028438. Inclusion in this directory is not an endorsement.