| NCT ID | NCT04692493 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 924 participants |
| Start Date | 2021-09-22 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 924 participants in total. It began in 2021-09-22 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jasvinder Singh, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT04692493 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04692493 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 924 participants.
Is NCT04692493 currently recruiting?
Yes, NCT04692493 is actively recruiting participants. Contact the research team at Jsingh@uabmc.edu for enrollment information.
Where is the NCT04692493 trial being conducted?
This trial is being conducted at Auburn, United States, Birmingham, United States, Birmingham, United States, Peoria, United States and 11 additional locations.
Who is sponsoring the NCT04692493 clinical trial?
NCT04692493 is sponsored by University of Alabama at Birmingham. The principal investigator is Jasvinder Singh, MD at University of Alabama at Birmingham. The trial plans to enroll 924 participants.
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