2023-504045-31-00CompletedPhase 2
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)
Janssen - Cilag International10 sites in 3 countries55 target enrollmentStarted: October 9, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 55
- Locations
- 10
- Primary Endpoint
- Change from baseline in DAS28-CRP at Week 12
Study Overview
Brief Summary
To evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy in participants with moderately to severely active RA despite ≥1 advanced therapy (bDMARDs or tsDMARDs).
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
-
Auxiliary
Participants receiving -
Intervention: - (Drug)
Outcomes
Primary Outcomes
Change from baseline in DAS28-CRP at Week 12
Change from baseline in DAS28-CRP at Week 12
Secondary Outcomes
No secondary outcomes reported
Investigators
CTIS Point of Contact
Scientific
Janssen - Cilag International
Study Sites (10)
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