An Observational Study to Assess Change in Disease Activity and Adverse Events of Rinvoq in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Japan

Study Identifier
P22-962
CT.gov Identifier
NCT05791526
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    15+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants diagnosed with moderately to severely active Ulcerative colitis (UC). * Participants who are within 14 days from the commencement of Rinvoq treatment for UC. * Participants who are administered the first dose of Rinvoq for UC after approval for UC in Japan.
    Exclusion Criteria:
    * Participants currently participating in registrational clinical trial. * Participants for whom Rinvoq is contraindicated. * Participants that have been previously exposed to Rinvoq.

    Protocol Summary

    Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective Rinvoq is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.

    Rinvoq is a drug approved for the treatment of ulcerative colitis (UC). All study participants will receive Rinvoq as prescribed by their study doctor in accordance with approved local label. Approximately 300 adult 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 60 weeks.

    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.

    Study Locations

    Location
    Status
    Location
    Anjou Kousei Hospital /ID# 256207
    Anjo-shi, Aichi-ken, Japan, 446-8602
    Status
    Not applicable
    Location
    Ichinomiyanishi Hospital /ID# 259498
    Ichinomiya-shi, Aichi-ken, Japan, 494-0001
    Status
    Not applicable
    Location
    Aikawa Minnano-shinryojo /ID# 258447
    Nagoya, Aichi-ken, Japan, 458-0011
    Status
    Not applicable
    Location
    Shimozato Clinic /ID# 261901
    Nagoya, Aichi-ken, Japan, 458-0044
    Status
    Not applicable
    Location
    Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049
    Nagoya, Aichi-ken, Japan, 461-0004
    Status
    Not applicable
    Location
    Yamada Coloproctology Clinic /ID# 259508
    Niwa-gun, Aichi-ken, Japan, 480-0147
    Status
    Not applicable
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