Status:
RECRUITING
An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
15+ years
Brief Summary
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely activ...
Eligibility Criteria
Inclusion
- Diagnosed with moderately to severely active Crohn's disease (CD).
- Has been prescribed upadacitinib for CD as per most current local approved label after its approval for CD in Japan.
- Within 14 days from the commencement of upadacitinib induction treatment for CD at the participating institution.
Exclusion
- Currently participating in another interventional clinical research.
- Participants for whom upadacitinib is contraindicated.
- Has been treated with upadacitinib for CD before and continue treatment with upadacitinib for CD at the participation to this study.
Key Trial Info
Start Date :
July 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06023030
Start Date
July 28 2023
End Date
November 1 2026
Last Update
April 17 2025
Active Locations (101)
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1
Anjou Kousei Hospital /ID# 261872
Anjo-shi, Aichi-ken, Japan, 446-8602
2
Handa City Hospital /ID# 270446
Handa, Aichi-ken, Japan, 475-8599
3
Aichi Medical University Hospital /ID# 261871
Nagakute, Aichi-ken, Japan, 480-1195
4
Masuko Memorial Hospital /ID# 267420
Nagoya, Aichi-ken, Japan, 453-0016