[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

877-379-3718

Email address

GSKClinicalSupportHD@gsk.com

Condition

Arthritis, Rheumatoid

Treatment type

Interventional

Investigational product

GSK3196165

Phase

Phase 3

Sponsor

GlaxoSmithKline

ClinicalTrials.gov identifier

NCT03970837

Study number

201791

Understanding clinical trials

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About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. >=18 years of age
  2. Has had RA for >=6 months and was not diagnosed before 16 years of age
  3. Has active disease, as defined by having both*
  4. >=6/68 tender/painful joint count (TJC), and
  5. >=6/66 swollen joint count (SJC)
  6. Has at least 1 bone erosion present on hand/wrist or foot radiographs
  7. Has had an inadequate response to one or two of the csDMARDs:
  8. methotrexate (MTX) 15-25 mg/week** oral or injected
  9. hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day
  10. sulfasalazine up to 3000 mg/day
  11. leflunomide up to 20 mg/day***
  12. bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement)
  13. iguratimod up to 50 mg/day
  14. If surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.
  15. A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.
  16. Concomitant use of leflunomide and methotrexate is not allowed, for safety reasons. Key
Exclusion criteria
  1. History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren's syndrome secondary to RA, that may confound the evaluation of the effect of the study intervention.
  2. 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.
  3. Has received prior treatment with an antagonist of GM-CSF or its receptor or Janus kinase (JAK) inhibitors (either experimental or approved).

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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