A study to evaluate nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis

Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: 1. Certolizumab + Placebo, active comparator. Participants will receive placebo intravenously (IV) and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by placebo IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22. 2. Certolizumab + Nipocalimab, Experimental. Participants will receive nipocalimab IV and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by nipocalimab IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22. Treatment allocation will be controlled by IWRS. CONDITION: Rheumatoid arthritis ; Musculoskeletal Diseases PRIMARY OUTCOME: Disease Activity Index Score 28 using C‐reactive Protein (DAS28‐CRP) at baseline and week 12 SECONDARY OUTCOME: ; 1. Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 12; 2. Percentage of Participants Achieving ACR 50 Response at Week 12; 3. Percentage of Participants Achieving ACR 70 Response at Week 12; 4. Percentage of Participants Achieving ACR 90 Response at Week 12; 5. Percentage of Participants Achieving DAS28‐CRP Remission at Week 12; 6. Percentage of Participants Achieving DAS28‐CRP Low Disease Activity (LDA) at Week 12; 7. Change From Baseline in Health Assessment Questionnaire‐Disability Inde X(HAQ‐DI) Score at Week 12; 8. Change From Baseline in Clinical Disease Activity Inde XScore (CDAI) at Week 12; 9. Number of Participants With Treatment‐emergent Adverse Events (TEAEs), up to week 30; 10. Number of Participants With Treatment‐emergent Serious Adverse Events (SAEs), up to week 30; 11. Number of Participants With TEAEs Leading to Discontinuation of Study Intervention, up to week 30; 12. Number of Participants With Adverse Events of Special interests (AESIs), Up to Week 30; INCLUSION CRITERIA: 1. Diagnosis of rheumatoid arthritis (RA) and meeting the 2010 American college of rheumatology (ACR) or European League Against Rheumatism (EULAR) criteria for RA for at least 3 months before screening 2. 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 3. Is positive for anti‐citrullinated protein antibodies (ACPA) or rheumatoid factor (RF) by the central laboratory at the time of screening 4. Has C‐reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciliter (mg/dL) by the central laboratory at the time of screening 5. If has received prior biological disease‐modifying antirheumatic drugs (bDMARDs) (or biosimilars) other than anti‐tumor necrosis factor (anti‐TNF) agent in RA, has demonstrated inadequate response (IR) or intolerance to the therapy based on one of the following:
Epistemonikos ID: 0cc629f48b69c77d592a5df03f1f0b2719371ccd
First added on: Aug 26, 2024