Study to Assess Treatment Patterns and Outcomes With Upadacitinib in Adult Participants With Inflammatory Bowel Disease in Belgium

StatusRecruiting
PhaseNot specified
SponsorAbbVie
Started

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Record History

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  1. Primary endpoints: details revised at 1 of 2 entries
    • Trial sites expanded: 7 → 11 locations
    • Eligibility criteria expanded, about 6 words
  2. Re-verified, no change to tracked fieldsv5
  3. Primary and study completion dates: Sep 28, 2029 to Sep 2029
    • Study title revised
    v4
  4. Study sites: 3 to 7v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Sep 2, 2024 to Sep 27, 2024
    v2
  6. Study First Submitted
  • 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.
AbbVie
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Crohn's Disease
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Ulcerative Colitis
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Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. This study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (UC) and crohn's disease (CD). Upadacitinib is an approved drug for treating ulcerative colitis (UC) and Crohn's disease (CD). Approximately 280 participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across Belgium. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice
Trial Details
NCT Number NCT06581042
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Ulcerative Colitis, Crohn's Disease
Related terms Colitis, Ulcerative, Crohn Disease
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov