RA-PRO PRAGMATIC TRIAL

Recruiting now · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic.

Key facts

Study ID

NCT04692493

Run by

University of Alabama at Birmingham

People needed

924

Starts

2021-09-22

Expected to finish

2029-07-31

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;
• 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 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;
• Latent TB for which anti-tubercular treatment has not been started;
• Untreated Hepatitis B or C infection;
• History of deep venous thrombosis or pulmonary embolism; or
• Pregnant or nursing women; or
• History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.

Where it is running

• East Alabama Arthritis Center PC — Auburn, Alabama, United States (enrolling)
• Bendcare, LLC — Birmingham, Alabama, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• SunValley Arthritis Center, Ltd — Peoria, Arizona, United States (enrolling)
• University of Arizona — Tucson, Arizona, United States (enrolling)
• Pacific Arthritis Care Center — Los Angeles, California, United States (enrolling)
• University of California, Los Angeles — Los Angeles, California, United States (enrolling)
• Arthritis Medical Center — Nipomo, California, United States (enrolling)
• Turlock Arthritis & Osteoporosis Center, — Turlock, California, United States (enrolling)
• Center for Rheumatology Research — Woodland Hills, California, United States (enrolling)
• George Munoz MD, PC — Aventura, Florida, United States (enrolling)
• American Arthritis and Rheumatology Associates LLC — Clearwater, Florida, United States (enrolling)
• CZ Rheumatology — Coral Springs, Florida, United States (enrolling)
• American Arthritis and Rheumatology Associates LLC — Fort Lauderdale, Florida, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• Palm Beach Rheumatology and Wellness — Jupiter, Florida, United States (enrolling)
• Arthritis & Rheumatology Center of South Florida — Margate, Florida, United States (enrolling)
• Life Medical Research Group — Miami Gardens, Florida, United States (enrolling)
• Southwest Florida Rheumatology — Riverview, Florida, United States (enrolling)
• Southeast Georgia Physician Associates-Rheumatology — Brunswick, Georgia, United States (enrolling)
• Indiana University Health — Carmel, Indiana, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Tufts University — Boston, Massachusetts, United States (enrolling)
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (enrolling)
• American Arthritis and Rheumatology Associates -Mi PLLC — Okemos, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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