CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Nipocalimab +1 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.

Search/NCT04991753
NCT04991753Phase 2Completed

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants With Active Rheumatoid Arthritis Despite Standard Therapy

Janssen Research & Development, LLC·interventional·Posted Aug 5, 2021·Updated Aug 22, 2025

In Brief

A Phase 2 clinical trial evaluating Placebo and Nipocalimab for Arthritis, Rheumatoid. Completed, enrolled 53 participants across 28 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 5, 2021
Enrollment StartOct 14, 2021
Primary CompletionAug 10, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.9 years ago

Interventions

Placeboother

Placebo infusion will be administered intravenously.

Nipocalimabdrug

Nipocalimab infusions will be administered intravenously.