Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis
NCT ID: NCT03028467 Phase: PHASE1 Status: COMPLETED Enrollment: 15 Completion: 2017-12-20
Conditions
Arthritis, Rheumatoid
Interventions
GSK3196165 Dose 1, GSK3196165 Dose 2, GSK3196165 Dose 3, Methotrexate, Placebo, Folic acid
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.
Primary Outcome
Maximum Observed Concentration (Cmax) of GSK3196165