A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept Study Evaluating the Efficacy and Safety of Nipocalimab Administered Intravenously in Participants with Active Rheumatoid Arthritis Despite Standard Therapy. - IRIS

Janssen-Cilag International NV0 个研究点目标入组 50 人开始时间: 2021年7月9日最近更新: 2021年10月8日

试验速览

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•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

•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.

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