Ensayos clínicos

Inclusion Criteria:

• Prior TNFi biologic treatment – Patient has active, moderate-high disease activity RA (CDAI ≥ 10 and HAQ ≥ 0.5) despite the use/experience for ≥ 3 months 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; AND
• Glucocorticoid and NSAID treatment - If receiving glucocorticoids (≤ 10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥ 2 weeks prior to randomization; AND
• Insurance - Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies for 1 year trial duration. 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 (TNFi-biologic and tsDMARD) through insurance plan or a patient assistance program/plan.

Exclusion Criteria:

• Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic.
• Prior treatment with targeted synthetic DMARD.
• Concomitant use of cyclosporine, or azathioprine within 2-months before randomization.
• History of sensitivity to all 4 non-TNF-biologic or a 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 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 or shingles.

Eligibility last updated 6/1/22. Questions regarding updates should be directed to the study team contact.