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RECRUITING

NCT04692493

PHASE3

RA-PRO PRAGMATIC TRIAL

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

924

Start Date

2021-09-22

Completion Date

2028-12-31

Last Updated

2025-07-18

Healthy Volunteers

Conditions

Rheumatoid Arthritis

Interventions

DRUG

targeted synthetic DMARD class

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

DRUG

non-TNFi-biologic class

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,

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.

Locations (49)

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