A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis

StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
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Record History

The 50 most recent of 59 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: 2 to 3
  2. Re-verified, no change to tracked fieldsv58
  3. Enrollment increased: 1056 → 1536 participantsv57
  4. Study site revisedv56
  5. 46 versions Re-verified since May 10, 2022, no change to tracked fieldsv10-v55
  • 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 purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).
Trial Details
NCT Number NCT04372108
Lead Sponsor Janssen Scientific Affairs, LLC
Conditions
(from sponsor)		 Crohn Disease, Colitis, Ulcerative
Related terms Colitis, Ulcerative, Crohn Disease
Enrollment 1,536 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov