NCT03028467

Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	GSK3196165 Dose 1	GSK3196165 is supplied as liquid and will be administered as SC injection.
DRUG	GSK3196165 Dose 2	GSK3196165 is supplied as liquid and will be administered as SC injection.
DRUG	GSK3196165 Dose 3	GSK3196165 is supplied as liquid and will be administered as SC injection.
DRUG	Methotrexate	Methotrexate capsule/tablet 8-16 mg per week is given orally.
DRUG	Placebo	Placebo is supplied as liquid as sterile 0.9% sodium chloride solution and will be administered as SC injection.
DRUG	Folic acid	Folic acid tablet 5 mg per week is given orally.

Timeline

• Start date: 2017-01-24
• Primary completion: 2017-12-20
• Completion: 2017-12-20
• First posted: 2017-01-23
• Last updated: 2019-06-26
• Results posted: 2019-06-26

Locations

32 sites across 1 country: Japan