RA-PRO PRAGMATIC TRIAL

Overview

About this study

The overall objective of this study is to examine if the strategy starting of the addition of a tsDMARD, oral targeted molecule medications will lead to greater improvement in HAQ compared with the alternate approach of the addition of a non-TNF-biologic.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Lynne Peterson, M.D.

Open for enrollment

Contact information:

Amber Woltzen

(507) 422-6732

Woltzen.Amber@mayo.edu

More information

Publications

Publications are currently not available