日本人関節リウマチ患者におけるGSK3196165とメトトレキサート併用療法の薬物動態および安全性評価

基本情報

NCT ID

NCT03028467

ステータス

完了

試験のフェーズ

第1/第2相

試験タイプ

介入

目標被験者数

15

治験依頼者名

GlaxoSmithKline

概要

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.

対象疾患

介入

依頼者（Sponsor）