RA-PRO PRAGMATIC TRIAL

NCT ID
NCT04692493
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
University of Alabama at Birmingham
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 924 participants (Estimated).

What is being studied

  • Drug: non-TNFi-biologic class
  • Drug: targeted synthetic DMARD class

Who may be eligible

Ages
18 Years to no maximum
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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.

Study locations

49 study locations are listed.

Recruiting site status is explicitly provided for 49 locations; 49 are listed as Recruiting.

Countries: Canada, United States

  • Ontario, Canada: 1
  • Alabama, United States: 3
  • Arizona, United States: 2
  • California, United States: 5
  • Florida, United States: 9
  • Georgia, United States: 1
  • Indiana, United States: 1
  • Maryland, United States: 1
  • Massachusetts, United States: 2
  • Michigan, United States: 1
  • Minnesota, United States: 2
  • New Mexico, United States: 2
  • New York, United States: 2
  • Ohio, United States: 4
  • Oregon, United States: 1
  • Pennsylvania, United States: 4
  • Tennessee, United States: 2
  • Texas, United States: 5
  • Virginia, United States: 1

Sample of listed locations

  • Mount Sinai Hospital (Canada) — Toronto, Ontario, M5T 3L9, Canada — Recruiting
  • East Alabama Arthritis Center PC — Auburn, Alabama, 36830, United States — Recruiting
  • Bendcare, LLC — Birmingham, Alabama, 35244, United States — Recruiting
  • University of Alabama at Birmingham — Birmingham, Alabama, 35294, United States — Recruiting
  • SunValley Arthritis Center, Ltd — Peoria, Arizona, 85381, United States — Recruiting
  • University of Arizona — Tucson, Arizona, 85724, United States — Recruiting
  • Pacific Arthritis Care Center — Los Angeles, California, 90045, United States — Recruiting
  • University of California, Los Angeles — Los Angeles, California, 90095, United States — Recruiting
  • Arthritis Medical Center — Nipomo, California, 93444, United States — Recruiting
  • Turlock Arthritis & Osteoporosis Center, — Turlock, California, 95382, United States — Recruiting
  • Center for Rheumatology Research — Woodland Hills, California, 91364, United States — Recruiting
  • George Munoz MD, PC — Aventura, Florida, 33180, United States — Recruiting
  • American Arthritis and Rheumatology Associates LLC — Clearwater, Florida, 33765, United States — Recruiting
  • CZ Rheumatology — Coral Springs, Florida, 33065, United States — Recruiting
  • American Arthritis and Rheumatology Associates LLC — Fort Lauderdale, Florida, 33309, United States — Recruiting
  • Mayo Clinic Jacksonville — Jacksonville, Florida, 32224, United States — Recruiting
  • Palm Beach Rheumatology and Wellness — Jupiter, Florida, 33458, United States — Recruiting
  • Arthritis & Rheumatology Center of South Florida — Margate, Florida, 33063, United States — Recruiting
  • Life Medical Research Group — Miami Gardens, Florida, 33014, United States — Recruiting
  • Southwest Florida Rheumatology — Riverview, Florida, 33569, United States — Recruiting
  • Southeast Georgia Physician Associates-Rheumatology — Brunswick, Georgia, 31520, United States — Recruiting
  • Indiana University Health — Carmel, Indiana, 46280, United States — Recruiting
  • Johns Hopkins University — Baltimore, Maryland, 21224, United States — Recruiting
  • Tufts University — Boston, Massachusetts, 02111, United States — Recruiting
  • University of Massachusetts Chan Medical School — Worcester, Massachusetts, 01655, United States — Recruiting

Study details

Start date
September 22, 2021
Primary completion date
May 31, 2029
Completion date
July 31, 2029
First posted
December 31, 2020
Collaborators
Patient-Centered Outcomes Research Institute

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT04692493
Registry last updated
September 24, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT04692493 on ClinicalTrials.gov

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