A Phase 2a Multicenter, Randomized, Double Blind, Parallel-group, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Subjects with Active Rheumatoid Arthritis despite Prior Treatment with Advanced Therapies (bDMARD or tsDMARD) - 80202125ARA2002

Janssen - Cilag International0 sites85 target enrollmentStarted: June 7, 2023Last updated: July 22, 2024

Conditions

Trial Snapshot

No summary available.

•18 to 75 years of age, inclusive, Medically stable on the basis of clinical laboratory tests performed at screening, Diagnosis of RA and meeting the 2010 ACR/ EULAR Criteria for RA for at least 12 weeks before screening, Has moderate to severe active RA as defined by persistent disease activity with at least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at baseline, Is positive for ACPA or RF by the central laboratory at the time of screening

•Has a diagnosed or reported history or current signs or symptoms indicating severe, progressive, or uncontrolled hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (except RA), psychiatric, or metabolic disturbances, which are detected at screening assessments (ie, laboratory testing, physical examination, vital signs) or reported by the participant, Has other inflammatory diseases that might confound the evaluation of benefit in this study, including but not limited to Crohn’s disease, ulcerative colitis, interstitial lung disease, ankylosing spondylitis, psoriatic arthritis, primary Sjogren’s syndrome, SLE, and Lyme disease, Has a history of any clinically significant adverse reaction to therapeutic proteins (eg, mABs), including, but not limited to, allergic reactions or severe immediate hypersensitivity reactions, such as anaphylaxis, Allergies, hypersensitivity, or intolerance to investigational medicinal products, Has a diagnosis of congestive heart failure including medically controlled, asymptomatic congestive heart failure

Sponsor