“Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate”
This is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. The study will consist of a screening phase of up to 6 weeks followed by a 52-week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with MTX. Following the treatment phase, there will be an 8-week safety follow up period for those participants who do not continue into the long term-extension study.
Biological - GSK3196165
GSK3196165 solution in vial/pre-filled syringe (PFS) to be administered SC.
Drug - Tofacitinib 5 mg
Tofacitinib cap (over encapsulated 5mg tablet) to be administered orally.
Drug - Placebo to GSK3196165
Placebo sterile 0.9% w/v sodium chloride solution in vial/pre-filled syringe (PFS) to be administered SC.
Drug - Placebo to tofacitinib
Placebo cap (containing lactose) to be administered orally.
Drug - Methotrexate
Stable oral dose of MTX as SoC.
Drug - Folic (or folinic) acid
Folic (or folinic) acid >=5 mg/week.
A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate