Actively Recruiting
RA-PRO PRAGMATIC TRIAL
Led by University of Alabama at Birmingham · Updated on 2025-07-18
924
Participants Needed
49
Research Sites
379 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RA-PRO PRAGMATIC TRIAL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with active, disabling rheumatoid arthritis (CDAI 6510 and HAQ 650.5) despite use or experience of a TNFi-biologic, or who stopped these drugs due to intolerance or toxicity before starting the study drug
- If using glucocorticoids (up to 10 mg/day prednisone equivalent) or NSAIDs, must be on stable doses for at least 2 weeks before randomization
- Insurance or patient assistance programs must provide access to at least one drug from each treatment strategy: non-TNFi biologic and tsDMARD
- Participants may continue stable doses of certain conventional synthetic DMARDs (methotrexate, sulfasalazine, hydroxychloroquine, or leflunomide) if used for 3 months or more and stable for at least 4 weeks before starting the study drug
You will not qualify if you...
- Prior treatment with more than three biologics (TNFi or non-TNFi biologics)
- Prior treatment with any targeted synthetic DMARD
- Use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2 months before randomization
- Known sensitivity to all four non-TNFi biologics or any targeted synthetic DMARD
- Glucocorticoid injection within 1 month before study entry
- Live vaccine within 90 days before study entry
- Recent infections needing parenteral antibiotics or hospitalization within 1 month, or oral antibiotics within 2 weeks before study entry
- History of HIV or any opportunistic infection
- New York Heart Association Class III or IV heart failure
- Latent tuberculosis without started treatment
- Untreated hepatitis B or C infection
- History of deep venous thrombosis or pulmonary embolism
- Pregnant or nursing women
- Herpes zoster or shingles in the last 12 months without subsequent vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
East Alabama Arthritis Center PC
Auburn, Alabama, United States, 36830
Actively Recruiting
2
Bendcare, LLC
Birmingham, Alabama, United States, 35244
Actively Recruiting
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
4
SunValley Arthritis Center, Ltd
Peoria, Arizona, United States, 85381
Actively Recruiting
5
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
6
Pacific Arthritis Care Center
Los Angeles, California, United States, 90045
Actively Recruiting
7
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
8
Arthritis Medical Center
Nipomo, California, United States, 93444
Actively Recruiting
9
Turlock Arthritis & Osteoporosis Center,
Turlock, California, United States, 95382
Actively Recruiting
10
Center for Rheumatology Research
Woodland Hills, California, United States, 91364
Actively Recruiting
11
George Munoz MD, PC
Aventura, Florida, United States, 33180
Actively Recruiting
12
American Arthritis and Rheumatology Associates LLC
Clearwater, Florida, United States, 33765
Actively Recruiting
13
CZ Rheumatology
Coral Springs, Florida, United States, 33065
Actively Recruiting
14
American Arthritis and Rheumatology Associates LLC
Fort Lauderdale, Florida, United States, 33309
Actively Recruiting
15
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
16
Palm Beach Rheumatology and Wellness
Jupiter, Florida, United States, 33458
Actively Recruiting
17
Arthritis & Rheumatology Center of South Florida
Margate, Florida, United States, 33063
Actively Recruiting
18
Life Medical Research Group
Miami Gardens, Florida, United States, 33014
Actively Recruiting
19
Southwest Florida Rheumatology
Riverview, Florida, United States, 33569
Actively Recruiting
20
Southeast Georgia Physician Associates-Rheumatology
Brunswick, Georgia, United States, 31520
Actively Recruiting
21
Indiana University Health
Carmel, Indiana, United States, 46280
Actively Recruiting
22
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Actively Recruiting
23
Tufts University
Boston, Massachusetts, United States, 02111
Actively Recruiting
24
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
25
American Arthritis and Rheumatology Associates -Mi PLLC
Okemos, Michigan, United States, 48864
Actively Recruiting
26
Saint Paul Rheumatology, P.A.
Eagan, Minnesota, United States, 55121
Actively Recruiting
27
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
28
Dr. Jayashree Sinha
Clovis, New Mexico, United States, 88101
Actively Recruiting
29
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, United States, 87505
Actively Recruiting
30
New York University
New York, New York, United States, 10016
Actively Recruiting
31
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
32
University Hospital Cleveland Medical Ctr
Cleveland, Ohio, United States, 44106
Actively Recruiting
33
The MetroHealth System
Cleveland, Ohio, United States, 44109
Actively Recruiting
34
Arthritis and Rheumatology of Southwest Ohio
Liberty Township, Ohio, United States, 45069
Actively Recruiting
35
Southern Ohio Rheumatology
Wheelersburg, Ohio, United States, 45694
Actively Recruiting
36
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
37
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
38
Rheumatology and Arthritis Care Center
Exton, Pennsylvania, United States, 19341-2547
Actively Recruiting
39
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
40
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, United States, 19610
Actively Recruiting
41
Cumberland Rhematology
Crossville, Tennessee, United States, 38555
Actively Recruiting
42
Vanderbilt University
Nashville, Tennessee, United States, 37235
Actively Recruiting
43
Heritage Rheumatology and Arthritis Care
Colleyville, Texas, United States, 76034
Actively Recruiting
44
Southwest Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
45
Texas Arthritis Center, PA
El Paso, Texas, United States, 77902
Actively Recruiting
46
American Arthritis and Rheumatology Associates-Tx PLLC
Harlingen, Texas, United States, 78550
Actively Recruiting
47
Baylor University
Houston, Texas, United States, 77030
Actively Recruiting
48
Northern Virginia Center for Arthritis-Reston
Reston, Virginia, United States, 20190
Actively Recruiting
49
Mount Sinai Hospital (Canada)
Toronto, Ontario, Canada, M5T 3L9
Actively Recruiting
Research Team
J
Jasvinder Singh
CONTACT
J
Jeff Foster, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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