RecruitingPhase 3NCT04692493

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)

Sponsor

University of Alabama at Birmingham

Enrollment

924 participants

Start Date

Sep 22, 2021

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pragmatic trial compares two types of medications for rheumatoid arthritis (RA) in patients who have not responded well to or could not tolerate a TNF inhibitor (a common biologic drug): another biologic targeting TNF versus a newer oral medication called a tsDMARD (like a JAK inhibitor). The goal is to find which approach works best in real-world practice. **You may be eligible if...** - You have active, disabling rheumatoid arthritis (based on disease activity and disability scores) - Your RA has not responded well to a TNF inhibitor biologic, or you stopped it due to side effects - Your insurance or a patient assistance program covers at least one of the two treatment options being compared **You may NOT be eligible if...** - Your RA disease activity or disability scores do not meet the minimum thresholds - You cannot access either of the study treatment types through insurance or assistance programs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtargeted 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

DRUGnon-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,

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

View Full Details on ClinicalTrials.gov

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