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/biologic DMARDs.
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Rheumatoid Arthritis
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Age: Between 18 - 100 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Diagnosed with active rheumatoid arthritis (RA) according to the ACR/EULAR 2010 RA Classification Criteria
- Must have active disease at both screening and baseline
- Male or female participants are eligible to participate so long as they meet and agree to abide by the contraceptive criteria
- Participants who will provide written informed consent.
You may not be eligible for this study if the following are true:
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- Active infections, or history of recurrent infections, or has required management of acute or chronic infections
- Symptomatic herpes zoster
- Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency
- Known infection with human immunodeficiency virus (HIV) or positive test at screening
- History of infected joint prosthesis
- Current unstable liver or biliary disease
- Current acute or chronic Hepatitis B and/or Hepatitis C
- Current or history of renal disease
- Breast cancer within the past 10 years or lymphoma, leukaemia, or any other malignancy within the past 5 years
- History of any lymphoproliferative disorder
- History or presence of significant other concomitant illness
- History of other inflammatory rheumatologic or systemic autoimmune disorder, other than Sjögren’s syndrome secondary to RA
- Current or previous active Mycobacterium tuberculosis (TB)
- Any condition or contraindication as addressed in the local product information or local clinical practice for tofacitinib that would preclude the participant from participating in this protocol.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.