RA-PRO PRAGMATIC TRIAL

Prior treatment

• Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
• Prior treatment with targeted synthetic DMARD
• Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;
• Live vaccine within 90 days of study entry;
• History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.

Other illness

• History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;
• Acute or chronic infections with parenteral antibiotics or hospitalization (including tuberculosis, bacterial sepsis; invasive fungal infections (such as histoplasmosis)) within 1 month or oral antibiotics within 2 weeks of study entry;
• History of HIV or any opportunistic infection;
• New York Heart Association Class III or IV heart failure;
• Untreated Hepatitis B or C infection;
• History of deep venous thrombosis or pulmonary embolism; or

Other

• Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;
• Latent TB for which anti-tubercular treatment has not been started;
• Pregnant or nursing women; or

• Patients with active, disabling RA (CDAI ≥10 and HAQ ≥0.5) despite the use/experience of a TNFi-biologic OR discontinued the medication(s) due to intolerability or toxicity irrespective of treatment duration prior to the first dose of study drug ;
• If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and
• Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies, TNFi-biologic vs. tsDMARD.(TNFi-biologic and tsDMARD) will be obtained through insurance plan or a patient assistance program/plan.
  • Participants will be allowed to continue their conventional synthetic DMARD (csDMARD) therapy if they had been using it for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, and leflunomide