NCT02504671

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

A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination With Methotrexate Therapy, in Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2015-07-23
• Primary completion: 2017-12-22
• Completion: 2017-12-29
• First posted: 2015-07-22
• Last updated: 2021-01-11
• Results posted: 2019-04-04

Locations

64 sites across 14 countries: Bulgaria, Canada, Czechia, Estonia, Germany, Hungary, Italy, Mexico, Poland, Russia, South Africa, Spain, Ukraine, United Kingdom