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Rheumatoid Arthritis

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.

Inclusion Criteria

( Answer of "Yes" to qualify)

Exclusion Criteria

( Answer of "No" to qualify)

  • More then 18 years of age

  • Diagnosis of RA for at least 6 months 

  • Diagnosis of RA after the age of 16

  • Must have a minimum of 6 swollen and 6 tender joints

  • Body weight of at least 90 pounds

  • Must have at least 1 bone erosion present on hand/wrist or foot (confirmed via x-ray at screening visit)

  • Must be currently on one of the following medications without receiving adequate results:

               a. Methotrexate (MTX): weekly 15-25 mg oral or injected, for at                     least 12 weeks at the maximum tolerated dose prior to Day 1,                     with no change in route of administration in this time. A                             lower dose of ≥7.5 mg/week is acceptable if reduced for                               reasons of intolerance to MTX, e.g. nausea/vomiting, hepatic                     or hematologic toxicity, or per local requirement (there must                     be clear documentation in the medical record). Exception: A                       lower dose of 6 mg/week is allowed if the minimum locally                           approved or recommended dose is lower than 7.5 mg/week.
               b. Hydroxychloroquine up to 400 mg/day or chloroquine up to                       250 mg/day.
               c. Sulfasalazine up to 3000 mg/day.
               d. Leflunomide up to 20 mg/day. Note: concomitant use of                               leflunomide and methotrexate is not allowed, for safety                               reasons.
               e. Bucillamine up to 100 mg/day (or up to 300 mg/day if                                   permitted per local requirements).
               f. Iguratimod up to 50 mg/day.

  • Any active or recurrent infections

  • Current Diagnosis of any type of immunodeficiency disease

  • Known infection if human immunodeficiency virus (HIV)

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