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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
With
IQVIA Pty Ltd
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\>=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.
You may not be if
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.
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).
Clareo Health | 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)
