Site for Rheumatoid Arthritis-patient reported outcomes (RA-PRO) study for treatment strategies after methotrexate inadequate-response (MTX-IR)

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 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Patients with active, moderate-high disease activity RA despite the use of MTX =3 months with a stable dose =15 mg/week (oral or subcutaneous) for =2 months (withholding of MTX for 1-week after for COVID-19 vaccination will be allowed);
    2. If receiving glucocorticoids (=10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for =2 weeks prior to randomization
    3. Patient has access to at least 1 drug in each of the two treatment strategies (TNFi-biologic and tsDMARD) through insurance plan or a patient assistance program/plan

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

    1. Use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization
    2. History of sensitivity to a TNFi-biologic or a targeted synthetic DMARD
    3. Prior treatment with a TNFi-biologic, non-TNFi biologic or targeted synthetic DMARD
    4. Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry
    5. Live vaccine within 90 days of study entry
    6. Acute infection treated with parenteral antibiotics or hospitalization (including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis)) within 1 month or with oral antibiotics within 2 weeks of study entry; or chronic infections requiring long-term antibiotic suppressive therapy
    7. History of HIV or opportunistic infections
    8. Class III or IV heart failure
    9. Latent TB not treated with anti-mycobacterial medication
    10. Untreated Hepatitis B or C infection
    11. History of deep venous thrombosis or pulmonary embolism
    12. Pregnant or nursing women
    13. History of herpes zoster, and never vaccinated with a recombinant herpes zoster vaccine



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