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NCT04991753 · ClinicalTrials.gov registry record · Phase 2
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT04991753: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT04991753 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04991753, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab versus placebo in participants with moderate to severe active rheumatoid arthritis (RA).
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
- OTHER Placebo
- DRUG Nipocalimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2022-08-10 |
| Phase | Phase 2 |
What the finished NCT04991753 record still lists
NCT04991753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04991753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04991753 about?
NCT04991753 is a clinical study titled "A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis". The purpose of this study is to evaluate the efficacy and safety of nipocalimab versus placebo in participants with moderate to severe active rheumatoid arthritis (RA).
What is the current status of trial NCT04991753?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2021-10-14. Estimated completion is 2022-08-10.
What interventions are being tested in trial NCT04991753?
The interventions under investigation include: Placebo (OTHER), Nipocalimab (DRUG).
Who is sponsoring clinical trial NCT04991753?
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 NCT04991753's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 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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