RA-PRO PRAGMATIC TRIAL
Recruiting · NCT04692493 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alabama at Birmingham
View the official record on ClinicalTrials.gov →Interventions studied
non-TNFi-biologic classtargeted synthetic DMARD class
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where it is running
49 locations listed across 18 US states.
- 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