Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
924 participants
INTERVENTIONAL
2021-09-22
2028-12-31
Brief Summary
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A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
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Detailed Description
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The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic first, i.e., a second TNFi. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and physician experience (first TNFi launched 22 yrs ago vs. the first tsDMARD 8 yrs 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. This will facilitate informed decision-making, since PROs may be more sensitive to different mechanisms of action, and are highly relevant to patients.
The proposed study will also provide needed evidence for real-world treatment decisions made by public and private payers. This head-to-head pragmatic trial will be the first to provide CER data for improvement in key PROs with recommended strategies in active RA despite the use of a TNFi-biologic and addresses PCORI and IOM priority areas by comparing the two most commonly used RA treatment strategies for people with active RA despite the use of a TNFi-biologic. This research is patient-centered, as study outcomes were identified by patients and payers. Currently, treatment choices are based on physician experience and insurance payer limitations. Investigators will generate evidence to help patients make decisions for themselves based on outcomes they care most about based on the relative efficacy of outcomes.
Investigators will: (1) compare improvements in PROs with RA treatment strategies to each other using a state-of-the-art real-world pragmatic effectiveness study design, which will for the first time include most RA patients with comorbidities;(2) compare their toxicity in a real-world population for TNFi-biologic vs. tsDMARD. To our knowledge, no previous RCT comparing these drugs has examined a PRO as a primary outcome in RA, which our study will pioneer by using HAQ. HAQ is sensitive to change with effective treatments.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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,
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,
Interventions
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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
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,
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Jasvinder A Singh
Professor of Medicine
Principal Investigators
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Jasvinder Singh, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Howard Busch, MD
Role: primary
Kent C Kwoh, MD
Role: primary
Dan Furst, MD
Role: primary
Veena K. Ranganath, MD
Role: primary
Role: backup
Vikas Majithia, MD
Role: primary
Uzma Haque, MD
Role: primary
Sreelakshmi Panginikkod, MD
Role: primary
Jonathan Kay, MD
Role: primary
Lynne Peterson, MD
Role: primary
Pamela Rosenthal, MD
Role: primary
Susan Goodman, MD
Role: primary
Marina N Magrey, MD
Role: primary
Nora Singer, MD
Role: primary
Cong-Qiu Chu, MD
Role: primary
Alan J Kivitz, MD, CPI
Role: primary
Kevin W Byram, MD
Role: primary
Bindee Kuriya, MD
Role: primary
Other Identifiers
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CER-2020C1-19193
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IRB-300006596
Identifier Type: -
Identifier Source: org_study_id
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