RA-PRO PRAGMATIC TRIAL
RA-PROPR
A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)
2 other identifiers
interventional
924
2 countries
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Sep 2021
Longer than P75 for phase_3 rheumatoid-arthritis
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2020
CompletedFirst Posted
Study publicly available on registry
December 31, 2020
CompletedStudy Start
First participant enrolled
September 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 18, 2025
July 1, 2025
5.4 years
December 15, 2020
July 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Functional Limitation
Function limitation assessed by Health assessment questionnaire (HAQ); HAQ assesses difficulty in 20 items in 8 categories (dressing, arising, eating, walking, hygiene, reaching, gripping, and outside activity), the total score ranges from 0 (no disability) to 3 (complete disability). Higher score is worse, and indicates poor function.
Change from baseline to 12 months
Study Arms (2)
targeted synthetic DMARD class
ACTIVE COMPARATORSwitching 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
ACTIVE COMPARATORSwitching 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,
Interventions
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
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
You may qualify if:
- 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 ;
- If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and
- 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
You may not qualify if:
- Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
- Prior treatment with targeted synthetic DMARD
- Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;
- History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;
- Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;
- Live vaccine within 90 days of study entry;
- 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;
- History of HIV or any opportunistic infection;
- New York Heart Association Class III or IV heart failure;
- Latent TB for which anti-tubercular treatment has not been started;
- Untreated Hepatitis B or C infection;
- History of deep venous thrombosis or pulmonary embolism; or
- Pregnant or nursing women; or
- History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
East Alabama Arthritis Center PC
Auburn, Alabama, 36830, United States
Bendcare, LLC
Birmingham, Alabama, 35244, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
SunValley Arthritis Center, Ltd
Peoria, Arizona, 85381, United States
University of Arizona
Tucson, Arizona, 85724, United States
Pacific Arthritis Care Center
Los Angeles, California, 90045, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Arthritis Medical Center
Nipomo, California, 93444, United States
Turlock Arthritis & Osteoporosis Center,
Turlock, California, 95382, United States
Center for Rheumatology Research
Woodland Hills, California, 91364, United States
George Munoz MD, PC
Aventura, Florida, 33180, United States
American Arthritis and Rheumatology Associates LLC
Clearwater, Florida, 33765, United States
CZ Rheumatology
Coral Springs, Florida, 33065, United States
American Arthritis and Rheumatology Associates LLC
Fort Lauderdale, Florida, 33309, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Palm Beach Rheumatology and Wellness
Jupiter, Florida, 33458, United States
Arthritis & Rheumatology Center of South Florida
Margate, Florida, 33063, United States
Life Medical Research Group
Miami Gardens, Florida, 33014, United States
Southwest Florida Rheumatology
Riverview, Florida, 33569, United States
Southeast Georgia Physician Associates-Rheumatology
Brunswick, Georgia, 31520, United States
Indiana University Health
Carmel, Indiana, 46280, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Tufts University
Boston, Massachusetts, 02111, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
American Arthritis and Rheumatology Associates -Mi PLLC
Okemos, Michigan, 48864, United States
Saint Paul Rheumatology, P.A.
Eagan, Minnesota, 55121, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Dr. Jayashree Sinha
Clovis, New Mexico, 88101, United States
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, 87505, United States
New York University
New York, New York, 10016, United States
Hospital for Special Surgery
New York, New York, 10021, United States
University Hospital Cleveland Medical Ctr
Cleveland, Ohio, 44106, United States
The MetroHealth System
Cleveland, Ohio, 44109, United States
Arthritis and Rheumatology of Southwest Ohio
Liberty Township, Ohio, 45069, United States
Southern Ohio Rheumatology
Wheelersburg, Ohio, 45694, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Rheumatology and Arthritis Care Center
Exton, Pennsylvania, 19341-2547, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610, United States
Cumberland Rhematology
Crossville, Tennessee, 38555, United States
Vanderbilt University
Nashville, Tennessee, 37235, United States
Heritage Rheumatology and Arthritis Care
Colleyville, Texas, 76034, United States
Southwest Medical Center
Dallas, Texas, 75235, United States
Texas Arthritis Center, PA
El Paso, Texas, 77902, United States
American Arthritis and Rheumatology Associates-Tx PLLC
Harlingen, Texas, 78550, United States
Baylor University
Houston, Texas, 77030, United States
Northern Virginia Center for Arthritis-Reston
Reston, Virginia, 20190, United States
Mount Sinai Hospital (Canada)
Toronto, Ontario, M5T 3L9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jasvinder Singh, MD
University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
December 15, 2020
First Posted
December 31, 2020
Study Start
September 22, 2021
Primary Completion (Estimated)
February 28, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
July 18, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share