An Open-Label Extension and Long-term Efficacy and Safety Monitoring Study of Patients With Crohn's Disease Previously Included in the Loss of RESponse to Ustekinumab Treated by Dose Escalation Study

Study acronym: REScUE-OLE
StatusCompleted
PhasePhase 3
Started

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Record History

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  1. Trial completed Show 6 more changesShow less
    • Final enrollment: 41 participants (planned 108)
    • Primary and study completion dates changed from estimate of Jun 2026 to May 29, 2026
    • Secondary endpoints: details revised at 15 of 17 entries
    • Study description expanded, about 10 words
    • Collaborators: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 1 word
  2. Primary and study completion dates: Dec 2025 to Jun 2026v4
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of the study is to assess the long-term efficacy and safety of a ustekinumab 90mg subcutaneous (SC) every 4 weeks (Q4w) regimen in patients with Crohn's disease previously enrolled in the REScUE study (NCT04245215) because of secondary loss of response to a ustekinumab 90mg SC every 8 weeks (Q8w) regimen.
Trial Details
NCT Number NCT05299931
Lead Sponsor Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborators: Janssen Cilag N.V./S.A.
Conditions
(from sponsor)		 Crohn Disease
Related terms Crohn Disease
Enrollment 41 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov