RECRUITING

RA-PRO PRAGMATIC TRIAL

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR)

Quick Facts

Study Start:2021-09-22
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04692493

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients with active, disabling RA (CDAI ≥10 and HAQ ≥0.5) despite the use/experience for ≥ 3 months 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 ;
  2. 2. If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and
  3. 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.
  1. 1. Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
  2. 2. Prior treatment with targeted synthetic DMARD
  3. 3. Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;
  4. 4. History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;
  5. 5. Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;
  6. 6. Live vaccine within 90 days of study entry;
  7. 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. 8. History of HIV or any opportunistic infection;
  9. 9. New York Heart Association Class III or IV heart failure;
  10. 10. Latent TB for which anti-tubercular treatment has not been started;
  11. 11. Untreated Hepatitis B or C infection;
  12. 12. History of deep venous thrombosis or pulmonary embolism; or
  13. 13. Pregnant or nursing women; or
  14. 14. History of herpes zoster or shingles.

Contacts and Locations

Study Contact

Jasvinder Singh
CONTACT
205-975-2405
Jsingh@uabmc.edu
Jeff Foster, MPH
CONTACT
205-996-6086
pjfoster@uabmc.edu

Principal Investigator

Jasvinder Singh, MD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Jasvinder Singh, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-22
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2021-09-22
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis