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

NCT03028467 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-06-26

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2017-12-20
Completion
2017-12-20

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03028467 on ClinicalTrials.gov