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Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.

Study acronym: VEDIAN
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 2026 to Oct 31, 2027 Completion date: Jan 2027 to Oct 31, 2028 · Eligibility criteria shortened, about 9 words · Secondary endpoints: 16 to 17 · 1 morev11 Show 4 more changesShow less
    • Completion date: Jan 2027 to Oct 31, 2028
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints: 16 to 17
    • Site details revised at 1 of 12 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv10
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2024 to Oct 31, 2024 · Site details revised at 12 of 12 sitesv9 Show 2 more changesShow less
    • Start date changed from estimate of Oct 2024 to Oct 31, 2024
    • Site details revised at 12 of 12 sites
  4. Start date: Sep 2024 to Oct 2024v8
  5. Start date: Jul 2024 to Sep 2024v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Jun 2024 to Jul 2024v6
  2. Start date: May 2024 to Jun 2024v5
  3. Primary completion date: Dec 2026 to Jan 2026 Completion date: Dec 2026 to Jan 2027 · Start date: Apr 2024 to May 2024 · Eligibility criteria expanded, about 14 words · 2 morev4 Show 5 more changesShow less
    • Completion date: Dec 2026 to Jan 2027
    • Start date: Apr 2024 to May 2024
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints revised (16)
    • Site contacts updated at 1 of 12 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Feb 1, 2024 to Apr 2024v3
  5. Interventions: Strategy A (Drug), Strategy B (Drug) to Adalimumab (Drug), Vedolizumab (Drug)v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class. Moreover, according to STRIDE 2 recommendations and CALM study, optimize patients based solely on lack of biological remission (CRP, calprotectin) can be discuss. If CALM study has showed that the intervention arm based on regular monitoring fecal calprotectin, CRP and/or CDAI to optimize patients under adalimumab was significantly associated to an increase rate of mucosal healing that the standard of care strategy based on only clinical activity, TDM was not available to guide drug optimization strategy.
Trial Details
NCT Number NCT06180382
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Takeda France
Conditions Crohn's Disease
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov