A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
Completed · Phase 2 · Has a placebo group
Conditions studied: Arthritis, Rheumatoid
In brief
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).
Key facts
- Study ID
- NCT04991753
- Run by
- Janssen Research & Development, LLC
- People needed
- 53
- Starts
- 2021-10-14
- Expected to finish
- 2022-08-10
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Is positive for anti-citrullinated protein antibodies (ACPA) and/or rheumatoid factor (RF) at screening
- Screening C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) by the central laboratory
- A woman of childbearing potential must have a negative highly sensitive urine pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine (beta-hCG) pregnancy test at Week 0 prior to administration of study intervention
You may not qualify if…
- Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before the first administration of study intervention or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first administration of study intervention)
- Is (anatomically or functionally) asplenic
- Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening
- Has other known inflammatory diseases that might confound the evaluations of benefit from nipocalimab therapy, including but not limited to ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Lyme disease
- Is currently taking immunoglobulin (Ig)G fragment crystallizable (Fc)-related protein therapeutics
Where it is running
- Arizona Arthritis & Rheumatology Associates PC — Glendale, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC — Mesa, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC — Tucson, Arizona, United States
- Desert Medical Advances — Palm Desert, California, United States
- Arthritis Care and Research Center Inc.: Smitha Reddy, MD — Poway, California, United States
- TriWest Research Associates, LLC — San Diego, California, United States
- Inland Rheumatology Clinical Trials, Inc. — Upland, California, United States
- DJL Clinical Research, PLLC — Charlotte, North Carolina, United States
- STAT Research, Inc. — Vandalia, Ohio, United States
- Low Country Rheumatology PA — Summerville, South Carolina, United States
- West Tennessee Research Institute — Jackson, Tennessee, United States
- Accurate Clinical Research, Inc. — Houston, Texas, United States
- Southwest Rheumatology Research LLC — Mesquite, Texas, United States
- Hamburger Rheuma Forschungszentrum II — Hamburg, Germany
- Rheumazentrum Ratingen — Ratingen, Germany
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy — Bydgoszcz, Poland
- NZOZ Lecznica Mak-Med sc — Nadarzyn, Poland
- Prywatna Praktyka Lekarska Prof Um Dr Hab Med Pawel Hrycaj — Poznan, Poland
- Centrum Medyczne AMED Targowek — Warsaw, Poland
- Hosp Univ A Coruna — A Coruña, Spain
- Hosp. Univ. de Basurto — Bilbao, Spain
- Hosp. Clinico Univ. de Santiago — Santiago de Compostela, Spain
- Hosp. Virgen Macarena — Seville, Spain
- Hosp. Do Meixoeiro — Vigo, Spain
- Western General Hospital — Edinburgh, United Kingdom
Full record on ClinicalTrials.gov
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