Rheumatoid Arthritis (RA) MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or Female, 18 to 75 years of age (inclusive) at the time of consent. 2. Diagnosis of RA and meeting the 2010 ACR / European League Against Rheumatism (EULAR) Criteria for RA for at least 3 months before screening. 3. 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. 4. Is positive for ACPA and/or RF at screening. 5. Screening C-reactive protein (CRP) =0.3 mg/dL by the central laboratory. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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). 3. Is (anatomically or functionally) asplenic. 4. Has experienced myocardial infarction (MI), unstable ischemic heart disease, or stroke within 12 weeks of screening. 5. 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. 6. Is currently taking IgG Fc-related protein therapeutics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of nipocalimab vs placebo in participants with moderate to severe active RA.;Secondary Objective: 1. To evaluate the safety and tolerability of nipocalimab vs placebo in participants with moderate to severe active RA. 2. To evaluate the PK and immunogenicity of IV nipocalimab in participants with moderate to severe active RA.;Primary end point(s): • Change from baseline in DAS28-CRP.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. Week 12 2. Week 12 3. Week 12 4. Week 12 5. Throughout the study 6. Throughout the study 7. W0, W2, W4, W8, W12, W18 8. W0, W2, W4, W8, W12, W18;Secondary end point(s): 1. Proportion of participants who achieve ACR20, ACR50, ACR70, and ACR90 responses. 2. Proportion of participants achieving DAS28-CRP remission. 3. Proportion of participants achieving DAS28-CRP LDA. 4. Change from baseline in HAQ-DI score. 5. Proportion of participants with treatment-emergent AE. 6. Proportion of participants with treatment-emergent SAEs. 7. Serum nipocalimab concentrations over time. 8. Incidence and titers of antibodies to nipocalimab in participants receiving active study intervention. | — |
Countries
Germany, Poland, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Operations
Janssen-Cilag, S.A
Outcome results
None listed