Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)

  • STATUS
    Recruiting
  • End date
    Nov 15, 2022
  • participants needed
    1500
  • sponsor
    GlaxoSmithKline
Updated on 14 May 2021
methotrexate
tofacitinib
hydroxychloroquine
rheumatic diseases
DMARD
sulfasalazine
leflunomide
arthralgia
chloroquine
erosion
antirheumatics

Summary

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.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment tofacitinib, csDMARDs, GSK3196165, Placebo to GSK3196165, Placebo to tofacitinib, GSK3196165 (Otilimab), Placebo to GSK3196165 (Otilimab)
Clinical Study IdentifierNCT03970837
SponsorGlaxoSmithKline
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

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
>=6/68 tender/painful joint count (TJC), and
>=6/66 swollen joint count (SJC)
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
Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons

Exclusion Criteria

History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjgren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention
Has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections
Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved)
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