Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate
This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.
This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation
study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid
arthritis patients who are receiving concomitant methotrexate.
Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with
REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over
16 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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