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A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

NCT04991753

CompletedPhase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Arthritis, Rheumatoid

Interventions: Placebo, Nipocalimab

Countries: United States, Germany, Poland, Spain, United Kingdom

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (28)
  • Glendale, Arizona, United States
  • Mesa, Arizona, United States
  • Tucson, Arizona, United States
  • Palm Desert, California, United States
  • Poway, California, United States
  • San Diego, California, United States
  • Upland, California, United States
  • Charlotte, North Carolina, United States
  • Vandalia, Ohio, United States
  • Summerville, South Carolina, United States
  • Jackson, Tennessee, United States
  • Houston, Texas, United States
  • Mesquite, Texas, United States
  • Hamburg, Germany
  • Ratingen, Germany
  • Bydgoszcz, Poland
  • Nadarzyn, Poland
  • Poznan, Poland
  • Warsaw, Poland
  • A Coruña, Spain
  • Bilbao, Spain
  • Santiago de Compostela, Spain
  • Seville, Spain
  • Vigo, Spain
  • Edinburgh, United Kingdom
  • London, United Kingdom
  • Newcastle, United Kingdom
  • Stoke-on-Trent, United Kingdom