NCT04692493From ClinicalTrials.govRecruiting

RA-PRO PRAGMATIC TRIAL

A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)

Rheumatoid Arthritis

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: University of Alabama at Birmingham
Enrolment target: 924
Started: 22 September 2021
Main results due: 31 May 2029
Study sites: 49
Registry updated: 24 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(49)

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

Showing 49 of 49 sites. 49 of the 49 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04692493. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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