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Precise Infliximab Exposure and Pharmacodynamic Control

Study acronym: REMODEL-CD
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv9
  2. Study sites: 10 to 11v8
  3. Site details revised at 1 of 10 sitesv7
  4. Secondary endpoints: details revised at 17 of 31 entries Site details revised at 8 of 10 sites · Eligibility criteria shortened, about 4 wordsv6 Show 2 more changesShow less
    • Site details revised at 8 of 10 sites
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 1, 2023 to Jul 1, 2023 · Site details revised at 10 of 10 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Apr 1, 2023 to Jul 1, 2023
    • Site details revised at 10 of 10 sites
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Mar 1, 2023 to Apr 1, 2023 Collaborators: 1 to 2v4 Show 1 more changeShow less
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv3
  3. Start date: Feb 1, 2023 to Mar 1, 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment. The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).
Trial Details
NCT Number NCT05660746
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Janssen Scientific Affairs, LLC
Conditions Crohn Disease
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov