RECRUITING Phase 3 ClinicalTrials.gov

RA-PRO PRAGMATIC TRIAL

Sponsor: University of Alabama at Birmingham • ClinicalTrials.gov ID: NCT04692493

Registry updated: 2026-09-24

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Description

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.

Interventions

targeted synthetic DMARD class (Drug)
Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite current treatment
non-TNFi-biologic class (Drug)
Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite current treatment,

Eligibility criteria

Inclusion Criteria: 1. 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 ; 2. If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and 3. 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 Exclusion Criteria: 1. Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic 2. Prior treatment with targeted synthetic DMARD 3. Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization; 4. History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD; 5. Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry; 6. Live vaccine within 90 days of study entry; 7. 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; 8. History of HIV or any opportunistic infection; 9. New York Heart Association Class III or IV heart failure; 10. Latent TB for which anti-tubercular treatment has not been started; 11. Untreated Hepatitis B or C infection; 12. History of deep venous thrombosis or pulmonary embolism; or 13. Pregnant or nursing women; or 14. History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.

Conditions

Rheumatoid Arthritis

Locations

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
CZ Rheumatology — Coral Springs, Florida, United States
American Arthritis and Rheumatology Associates LLC — Fort Lauderdale, Florida, United States
Mayo Clinic Jacksonville — Jacksonville, Florida, United States
Palm Beach Rheumatology and Wellness — Jupiter, Florida, United States
Arthritis & Rheumatology Center of South Florida — Margate, Florida, United States
Life Medical Research Group — Miami Gardens, Florida, United States
Southwest Florida Rheumatology — Riverview, Florida, United States
Southeast Georgia Physician Associates-Rheumatology — Brunswick, Georgia, United States
Indiana University Health — Carmel, Indiana, United States
Johns Hopkins University — Baltimore, Maryland, United States
Tufts University — Boston, Massachusetts, United States
University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States
American Arthritis and Rheumatology Associates -Mi PLLC — Okemos, Michigan, United States
Saint Paul Rheumatology, P.A. — Eagan, Minnesota, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Dr. Jayashree Sinha — Clovis, New Mexico, United States
Inspire Santa Fe Medical Group — Santa Fe, New Mexico, United States
New York University — New York, New York, United States
Hospital for Special Surgery — New York, New York, United States
University Hospital Cleveland Medical Ctr — Cleveland, Ohio, United States
The MetroHealth System — Cleveland, Ohio, United States
Arthritis and Rheumatology of Southwest Ohio — Liberty Township, Ohio, United States
Southern Ohio Rheumatology — Wheelersburg, Ohio, United States
Oregon Health and Science University — Portland, Oregon, United States
Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
Rheumatology and Arthritis Care Center — Exton, Pennsylvania, United States
Allegheny Health Network — Pittsburgh, Pennsylvania, United States
PA Regional Center for Arthritis and Osteoporosis Research — Wyomissing, Pennsylvania, United States
Cumberland Rhematology — Crossville, Tennessee, United States
Vanderbilt University — Nashville, Tennessee, United States
Heritage Rheumatology and Arthritis Care — Colleyville, Texas, United States
Southwest Medical Center — Dallas, Texas, United States
Texas Arthritis Center, PA — El Paso, Texas, United States
American Arthritis and Rheumatology Associates-Tx PLLC — Harlingen, Texas, United States
Baylor University — Houston, Texas, United States
Northern Virginia Center for Arthritis-Reston — Reston, Virginia, United States
Mount Sinai Hospital (Canada) — Toronto, Ontario, Canada

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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