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Monoclonal Antibodies

Nipocalimab for Rheumatoid Arthritis

Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of rheumatoid arthritis (RA) and meeting the 2010 American college of rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA for at least 3 months before screening
Has moderate to severe active RA as defined by persistent disease activity with at least 6 swollen and 6 tender joints out of the 66/68-swollen and tender joint count at the time of screening and at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights

Study Summary

This study is evaluating whether a drug called nipocalimab can help people with rheumatoid arthritis.

Eligible Conditions
  • Rheumatoid Arthritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
Secondary outcome measures
Diabetes Insipidus
Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12
Percentage of Participants Achieving DAS28-CRP Remission at Week 12
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: NipocalimabExperimental Treatment1 Intervention
Participants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy.
Group II: Group 1: PlaceboPlacebo Group1 Intervention
Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
973 Previous Clinical Trials
6,383,669 Total Patients Enrolled
6 Trials studying Rheumatoid Arthritis
722 Patients Enrolled for Rheumatoid Arthritis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,855 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
322 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Arizona
Indiana
How old are they?
18 - 65
What site did they apply to?
Arizona Arthritis & Rheumatology Associates PC
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~16 spots leftby Mar 2025