A Randomized Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Rheumatoid Arthritis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Have a diagnosis of adult-onset Rheumatoid Arthritis (RA)
    2. If RA symptom onset is <6 months, are rheumatoid factor or anticitrullinated antibody positive
    3. Be clinically suitable, in the investigator's opinion, to receive a targeted therapy
    4. Have moderately to severely active Rheumatoid Arthritis (RA)
    5. Have had an IR or intolerance to at least 1 DMARD (synthetic or biologic)
    6. Have at least one of the following 4 characteristics:
      • Documented evidence of a VTE prior to this study
      • Age =60 years
      • BMI =30 kg/m2
      • Age 50 to <60 years AND BMI 25 to <30 kg/m2
    7. Abstinent or use 1 highly effective method of contraception
    8. Provide written informed consent

You may not be eligible for this study if the following are true:

    1. Have any contraindications to a TNF inhibitor
    2. Are pregnant or breastfeeding
    3. Have a history of VTE (DVT/PE) within 12 weeks prior to randomization
    4. Have active primary or recurrent malignant disease or have been in remission from clinically significant malignancy for <5 years prior to randomization
    5. Have active herpes zoster
    6. Have a clinically serious infection or have any other active or recent infection that, in the opinion of the investigator, would pose an unacceptable risk to the participant
    7. Have a history or presence of any illness that, in the opinion of the investigator, could pose an unacceptable risk to the participant
    8. Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB
    9. Have evidence of active TB or untreated/inadequately/inappropriately treated for latent TB



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