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Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 5, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Enrolling by Invitation to Active, Not Recruiting Primary and study completion dates: Dec 31, 2026 to Sep 2026v16 Show 1 more changeShow less
    • Primary and study completion dates: Dec 31, 2026 to Sep 2026
  2. Enrollment target: 196 to 124 Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026v15 Show 1 more changeShow less
    • Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026
  3. Study sites: 19 to 25 Eligibility criteria expanded, about 75 words · Secondary endpoints: details revised at 7 of 12 entries · Study description expanded, about 4 words · 1 morev14 Show 4 more changesShow less
    • Eligibility criteria expanded, about 75 words
    • Secondary endpoints: details revised at 7 of 12 entries
    • Study description expanded, about 4 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 17 to 19v13
  5. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2024 Trial status: Recruiting to Enrolling by Invitation · Study sites: 16 to 17v12 Show 2 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 16 to 17
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 15 to 16v11
  2. Study sites: 14 to 15 Eligibility criteria expanded, about 75 wordsv10 Show 1 more changeShow less
    • Eligibility criteria expanded, about 75 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 13 to 14v9
  4. Study sites: 12 to 13v8
  5. Study sites: 9 to 12 Eligibility criteria shortened, about 15 wordsv7 Show 1 more changeShow less
    • Eligibility criteria shortened, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 5 to 9v6
  7. Study title expanded, about 8 wordsv5 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 3 to 5v4
  9. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 3 · Start date changed from estimate of Sep 17, 2021 to Nov 1, 2021 · Study description expanded, about 307 words · 1 morev3 Show 4 more changesShow less
    • Study sites: 1 to 3
    • Start date changed from estimate of Sep 17, 2021 to Nov 1, 2021
    • Study description expanded, about 307 words
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  10. Start date: Jul 1, 2021 to Sep 17, 2021v2
  1. 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.
The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease.
Trial Details
NCT Number NCT04835506
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust, Icahn School of Medicine at Mount Sinai
Conditions Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov