A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs
A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs
This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). 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 csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.
Key inclusion criteria
>=18 years of age
Has had RA for >=6 months and was not diagnosed before 16 years of age
Has active disease, as defined by having both*
Has at least 1 bone erosion present on hand/wrist or foot radiographs
Has had an inadequate response to one or two of the csDMARDs:
methotrexate (MTX) 15-25 mg/week** oral or injected
hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
sulfasalazine up to 3000 mg/day
leflunomide up to 20 mg/day***
bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)
iguratimod up to 50 mg/day
If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.
A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.
Key exclusion criteria
Ciudad Autonoma Buenos Aires, Buenos Aires C1114ABH, Argentina
Ciudad Autonoma Buenos Aires, Buenos Aires C1430EGF, Argentina
Ciudad Autonoma Buenos Aires, C1015ABO, Argentina
Hokkaido, 053-8567, Japan
Hokkaido, 060-0001, Japan
Hokkaido, 060-8604, Japan
Hokkaido, 060-8648, Japan
Hokkaido, 063-0811, Japan
Hokkaido, 085-0032, Japan
Mexico City, Durango 06700, Mexico
Anyang-Si, Gyeonggi-do, 14068, South Korea
Cheonan-si, 330-721, South Korea
Muang, 40002, Thailand
Rajathevee, 10400, Thailand