RA-PRO PRAGMATIC TRIAL

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• East Alabama Arthritis Center PC, Auburn, Alabama, United States
• Bendcare, LLC, Birmingham, Alabama, United States
• University of Alabama at Birmingham, Birmingham, Alabama, United States
• SunValley Arthritis Center, Ltd, Peoria, Arizona, United States
• University of Arizona, Tucson, Arizona, United States
• Pacific Arthritis Care Center, Los Angeles, California, United States
• University of California, Los Angeles, Los Angeles, California, United States
• Arthritis Medical Center, Nipomo, California, United States
• Turlock Arthritis & Osteoporosis Center,, Turlock, California, United States
• Center for Rheumatology Research, Woodland Hills, California, United States
• George Munoz MD, PC, Aventura, Florida, United States
• American Arthritis and Rheumatology Associates LLC, Clearwater, Florida, United States

+ 37 more sites.

Who to contact

Jasvinder Singh · 205-975-2405 · Jsingh@uabmc.edu

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04692493.