Ensayos clínicos

Inclusion Criteria:

• Patients with active, moderate-high disease activity RA (CDAI ≥ 10 and HAQ ≥ 0.5) despite the use of MTX ≥ 3 months with a stable dose ≥ 15 mg/week (oral or subcutaneous) for ≥ 2 months.
• A lower stable MTX dose of 7.5-15 mg weekly will be allowed instead of at least 15 mg weekly if the maximum tolerated dose is in this range and a higher dose is associated with documented intolerable gastrointestinal adverse event such as nausea, vomiting, diarrhea, mouth sores, or fatigue, despite the use of concomitant folic acid 1-5 mg oral daily,
• If receiving glucocorticoids (≤ 10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥ 2 weeks prior to randomization.
• 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.

Exclusion Criteria:

• Use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization.
• History of sensitivity to a TNFi-biologic or a targeted synthetic DMARD.
• Prior treatment with a TNFi-biologic, non-TNFi biologic or targeted synthetic DMARD.
• Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry.
• Live vaccine within 90 days of study entry.
• 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.
• History of HIV or opportunistic infections.
• New York Heart Association Class III or IV heart failure.
• Latent TB not treated with anti-mycobacterial medication.
• Untreated Hepatitis B or C infection.
• History of deep venous thrombosis or pulmonary embolism.
• Pregnant or nursing women.
• History of herpes zoster, and never vaccinated with a recombinant herpes zoster vaccine.

Eligibility last updated 10/21/21. Questions regarding updates should be directed to the study team contact.