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More info
You can access this
clinical trial
if you have
Arthritis, Rheumatoid
and you are
over 20
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: GSK3196165 Dose 1
  • Drug: GSK3196165 Dose 2
  • Drug: GSK3196165 Dose 3
  • Drug: Methotrexate
  • Drug: Placebo
  • Drug: Folic acid
Tris trial is registered with FDA with number: NCT03028467. The sponsor of the trial is GlaxoSmithKline and it is looking for 15 volunteers for the current phase.
Official trial title:
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