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MinorEligibility criteria expanded, about 17 wordsSite details revised at 18 of 49 sitesShow 1 more changeShow less
Site details revised at 18 of 49 sites
NotablePrimary completion date: Feb 28, 2027 to May 31, 2029Completion date: Dec 31, 2028 to Jul 31, 2029 · Site contacts updated at 18 of 49 sitesv13Show 2 more changesShow less
Completion date: Dec 31, 2028 to Jul 31, 2029
Site contacts updated at 18 of 49 sites
MinorSite contacts updated at 18 of 49 sitesEligibility criteria expanded, about 2 wordsv12Show 1 more changeShow less
MinorPrimary completion date: Sep 30, 2026 to Feb 28, 2027v10
Show 8 earlier versionsHide 8 earlier versions
MinorSite details revised at 2 of 49 sitesv9
MinorCompletion date: Dec 31, 2026 to Dec 31, 2028v8
MinorStudy sites: 41 to 49v7
MinorStudy sites: 1 to 41v6
NotablePhase: Phase 2 to Phase 3Primary completion date: Sep 30, 2025 to Sep 30, 2026 · Enrollment target: 664 to 924 · Completion date: Dec 31, 2025 to Dec 31, 2026 · 3 morev5Show 6 more changesShow less
Primary completion date: Sep 30, 2025 to Sep 30, 2026
Enrollment target: 664 to 924
Completion date: Dec 31, 2025 to Dec 31, 2026
Interventions: TNFi-biologic class (Drug), tsDMARD class (Drug) to non-TNFi-biologic class (Drug), targeted synthetic DMARD class (Drug)
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Sep 1, 2021 to Sep 22, 2021 · Site details revisedv4Show 2 more changesShow less
Start date changed from estimate of Sep 1, 2021 to Sep 22, 2021
Site details revised
NotableStart date: Jul 1, 2021 to Sep 1, 2021v3
MinorRe-verified, no change to tracked fieldsv2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.