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Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis

NCT02504671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2021-01-11

Study results available
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Summary

This is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group, placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised into the study, following a screening period of up to four weeks. The total treatment period is up to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects will be randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165 doses, in combination with MTX (at a weekly dose between 15-25 milligram \[mg\]), previously received for at least 12 weeks, with a stable and tolerated dose and route of administration for \>=4 weeks. Escape therapy is provided at specified timepoints in the protocol for subjects that do not achieve adequate disease improvement.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

GSK3196165

GSK3196165 is supplied as liquid and will be administered as SC injection.

DRUG

MTX

MTX will be supplied as capsule, tablet or liquid and will be administered orally or as SC injection.

DRUG

Folic acid

Folic acid will be supplied as capsule, tablet or liquid and will be administered orally.

DRUG

Placebo

Placebo is supplied as liquid as sterile 0.9% weight by volume (w/v) sodium chloride solution and will be administered as SC injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-23
Primary Completion
2017-12-22
Completion
2017-12-29

Countries

  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Russia
  • South Africa
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

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 NCT02504671 on ClinicalTrials.gov