At a glance
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A Phase 1/2, Double-Blind, Placebo-Controlled Study of the Pharmacokinetics, Safety and Tolerability of GSK3196165 in Combination With Methotrexate Therapy, in Japanese Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate
In Brief
A Phase 2 clinical trial evaluating GSK3196165 Dose 1, GSK3196165 Dose 2, and 4 other interventions for Arthritis, Rheumatoid. Completed, enrolled 15 participants across 32 sites.
Detailed Summary
This is a randomized, double-blind, parallel group, 3 dosage level, placebo-controlled, Phase 1/2 study designed to evaluate the pharmacokinetics, safety, tolerability, and efficacy of the monoclonal antibody GSK3196165, in Japanese subjects with active moderate-severe rheumatoid arthritis (RA) despite treatment with methotrexate(MTX). The subjects will receive GSK3196165 in combination with methotrexate therapy for the 12 weeks of treatment period. Approximately 55 subjects will be screened to achieve 40 randomized subjects, so as to have approximately 10 subjects in each treatment group.
Study Details
Timeline
Interventions
GSK3196165 is supplied as liquid and will be administered as SC injection.
GSK3196165 is supplied as liquid and will be administered as SC injection.
GSK3196165 is supplied as liquid and will be administered as SC injection.
Methotrexate capsule/tablet 8-16 mg per week is given orally.
Placebo is supplied as liquid as sterile 0.9% sodium chloride solution and will be administered as SC injection.
Folic acid tablet 5 mg per week is given orally.