RA-PRO PRAGMATIC TRIAL

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.

Conditions

Rheumatoid Arthritis

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Study Overview

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Study Details

Study overview

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.

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

RA-PRO PRAGMATIC TRIAL

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Auburn

East Alabama Arthritis Center PC, Auburn, Alabama, United States, 36830

Birmingham

Bendcare, LLC, Birmingham, Alabama, United States, 35244

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Peoria

SunValley Arthritis Center, Ltd, Peoria, Arizona, United States, 85381

Tucson

University of Arizona, Tucson, Arizona, United States, 85724

Los Angeles

Pacific Arthritis Care Center, Los Angeles, California, United States, 90045

Los Angeles

University of California, Los Angeles, Los Angeles, California, United States, 90095

Nipomo

Arthritis Medical Center, Nipomo, California, United States, 93444

Turlock

Turlock Arthritis & Osteoporosis Center,, Turlock, California, United States, 95382

Woodland Hills

Center for Rheumatology Research, Woodland Hills, California, United States, 91364

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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. 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.
  • 1. Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

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

Study Record Dates

2028-12-31