Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis

Study Identifier
P23-430
CT.gov Identifier
NCT05496348
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
  • Ulcerative Colitis (UC)
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants with an endoscopically confirmed diagnosis of active moderate to severe Ulcerative colitis (UC). * Participants initiating Upadacitinib (UPA) at the investigator's discretion as part of their routine clinical care; the decision to administer UPA must be made prior to and independent of documentation for the study and according to the approved local label. * Participants able to understand and communicate with the investigator and comply with the requirements of the study. * Participants willing to continue with study documentation after cessation of UPA.
    Exclusion Criteria:
    * Participants with any contraindication to Upadacitinib (UPA). * Participants previously exposed to a Janus kinase (JAK) inhibitor.

    Protocol Summary

    Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will assess how effective upadacitinib is in treating UC.

    Upadacitinib (RINVOQ) is an approved drug for treating UC. Approximately 400 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Germany, Austria and Switzerland.

    Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 2 years.

    There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and only data which are routinely collected during a regular visit will be utilized for this study.

    Study Locations

    Location
    Status
    Location
    Krankenhaus der Barmherzigen Brueder Wien /ID# 251867
    Vienna, State of Vienna, Austria, 1020
    Status
    Active, Not Recruiting
    Location
    Kepler Universitaetsklinikum GmbH /ID# 251868
    Linz, Upper Austria, Austria, 4020
    Status
    Active, Not Recruiting
    Location
    Krankenhaus der Barmherzigen Brueder Salzburg /ID# 251869
    Salzburg, Austria, 5010
    Status
    Active, Not Recruiting
    Location
    Universitaetsklinik Heidelberg /ID# 249922
    Heidelberg, Baden-Wurttemberg, Germany, 69120
    Status
    Active, Not Recruiting
    Location
    Praxis fuer Gastroenterologie - Heidelberg /ID# 249917
    Heidelberg, Baden-Wurttemberg, Germany, 69121
    Status
    Active, Not Recruiting
    Location
    Rems-Murr-Klinikum Winnenden /ID# 278791
    Winnenden, Baden-Wurttemberg, Germany, 71364
    Status
    Completed
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