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RA-PRO PRAGMATIC TRIAL
RA-PRO PRAGMATIC TRIAL

NCT04692493

RecruitingPhase 3

Sponsor: University of Alabama at Birmingham

Conditions: Rheumatoid Arthritis

Interventions: targeted synthetic DMARD class, non-TNFi-biologic class

Countries: United States, Canada

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. 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 ;
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:

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 in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.
Locations (49)
  • Auburn, Alabama, United States
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Peoria, Arizona, United States
  • Tucson, Arizona, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Nipomo, California, United States
  • Turlock, California, United States
  • Woodland Hills, California, United States
  • Aventura, Florida, United States
  • Clearwater, Florida, United States
  • Coral Springs, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Jacksonville, Florida, United States
  • Jupiter, Florida, United States
  • Margate, Florida, United States
  • Miami Gardens, Florida, United States
  • Riverview, Florida, United States
  • Brunswick, Georgia, United States
  • Carmel, Indiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Worcester, Massachusetts, United States
  • Okemos, Michigan, United States
  • Eagan, Minnesota, United States
  • Rochester, Minnesota, United States
  • Clovis, New Mexico, United States
  • Santa Fe, New Mexico, United States
  • New York, New York, United States
  • + 19 more on CT.gov