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

Study Identifier
P24-080
CT.gov Identifier
NCT06023030
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    15+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    * 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.

    Protocol 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 active CD in real world. Adverse events and change in disease activity will be assessed.

    Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 participants will be enrolled in Japan.

    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 64 weeks.

    There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

    Study Locations

    Location
    Status
    Location
    Anjou Kousei Hospital /ID# 261872
    Anjo-shi, Aichi-ken, Japan, 446-8602
    Status
    Recruiting
    Location
    Handa City Hospital /ID# 270446
    Handa, Aichi-ken, Japan, 475-8599
    Status
    Recruiting
    Location
    Aichi Medical University Hospital /ID# 261871
    Nagakute, Aichi-ken, Japan, 480-1195
    Status
    Recruiting
    Location
    Masuko Memorial Hospital /ID# 267420
    Nagoya, Aichi-ken, Japan, 453-0016
    Status
    Recruiting
    Location
    Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219
    Nagoya, Aichi-ken, Japan, 453-8511
    Status
    Recruiting
    Location
    Nagoya City University Hospital /ID# 275588
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Recruiting
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