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

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 21.0Level: PTClassification code: 10039073Term: Rheumatoid arthritis Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-504045-31-00
• Lead Sponsor: Janssen - Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified