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Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission

Study acronym: QUOTIENT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Mar 1, 2028 → Aug 1, 2028
Enrollment reduced 14% 250 → 216 participants
See other at-risk trials from Mayo Clinic

Record History

  1. Sponsor changed: University of California, San Diego to Mayo Clinic Primary completion pushed from Mar 1, 2028 to Aug 1, 2028 · Enrollment reduced: 250 → 216 participants · Completion pushed from Jun 1, 2028 to Feb 1, 2029 · 4 morev5 Show 7 more changesShow less
    • Primary completion pushed from Mar 1, 2028 to Aug 1, 2028
    • Enrollment reduced: 250 → 216 participants
    • Completion pushed from Jun 1, 2028 to Feb 1, 2029
    • Study sites: 22 to 24
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study description expanded, about 32 words

    See this version in full on ClinicalTrials.gov ↗

  2. Enrollment target: 478 to 250 Primary completion date: Nov 1, 2026 to Mar 1, 2028 · Study sites: 21 to 22 · Completion date: Dec 1, 2026 to Jun 1, 2028 · 2 morev4 Show 5 more changesShow less
    • Primary completion date: Nov 1, 2026 to Mar 1, 2028
    • Study sites: 21 to 22
    • Completion date: Dec 1, 2026 to Jun 1, 2028
    • Eligibility criteria shortened, about 26 words
    • Study description shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 1, 2022 to Oct 5, 2022 · Site details revised at 21 of 21 sitesv3 Show 2 more changesShow less
    • Start date changed from estimate of Jul 1, 2022 to Oct 5, 2022
    • Site details revised at 21 of 21 sites
  4. Start date: Apr 1, 2022 to Jul 1, 2022 Enrollment target: 346 to 478 · Study sites: 19 to 21 · Eligibility criteria expanded, about 14 words · 1 morev2 Show 4 more changesShow less
    • Enrollment target: 346 to 478
    • Study sites: 19 to 21
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  5. Study 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Mayo Clinic
1,019 trials monitored
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The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis \[UC\]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.
Trial Details
NCT Number NCT05230173
Lead Sponsor Mayo Clinic
Collaborators: Baylor College of Medicine, Crohn's and Colitis Foundation, Western University, Patient-Centered Outcomes Research Institute
Conditions Ulcerative Colitis, Crohn Disease
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov