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NCT06028438 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT06028438: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT06028438 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06028438, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
Primary Outcome
Change from baseline in DAS28-CRP at Week 12 were reported. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity, and C-reactive protein (CRP; in milligrams per liter \[mg/L\]). The set of 28 joint count was based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5
Interventions
- DRUG Placebo
- DRUG Nipocalimab
- DRUG Certolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2024-10-29 |
| Phase | Phase 2 |
What the finished NCT06028438 record still lists
NCT06028438 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT06028438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06028438 about?
NCT06028438 is a clinical study titled "A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis". The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
What is the current status of trial NCT06028438?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2023-08-15. Estimated completion is 2024-10-29.
What interventions are being tested in trial NCT06028438?
The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG), Certolizumab (DRUG).
Who is sponsoring clinical trial NCT06028438?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06028438's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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