Open Actively Recruiting



Brief Summary

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.

Primary Purpose
Study Type
Phase 3


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

  • 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 ;
  • 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. 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 (TNFi-biologic and tsDMARD) through insurance plan or a patient assistance program/plan.

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.

Join this Trial

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Study Stats
Protocol No.
Autoimmune Disorders
Michelle Ramirez
  • UCLA Alhambra
  • UCLA Arcadia
  • UCLA Beverly Hills
  • UCLA Burbank
  • UCLA Calabasas
  • UCLA Encino
  • UCLA Fountain Valley
  • UCLA Hollywood
  • UCLA Irvine
  • UCLA Laguna Hills
  • UCLA North Hollywood
  • UCLA Parkside
  • UCLA Pasadena
  • UCLA Playa Marina
  • UCLA Porter Ranch
  • UCLA Redondo Beach
  • UCLA San Luis Obispo
  • UCLA Santa Barbara
  • UCLA Santa Monica
  • UCLA Simi Valley
  • UCLA Torrance
  • UCLA Valencia
  • UCLA Ventura
  • UCLA Westlake Village
  • UCLA Westwood
  • UCLA Woodland Hills
For Providers
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