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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06023030
Recruitment Status : Recruiting
First Posted : September 5, 2023
Last Update Posted : April 25, 2024
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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 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.


Condition or disease
Crohn's Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan
Actual Study Start Date : July 28, 2023
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : November 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Groups and Cohorts
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Group/Cohort
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Drug Related Serious Infections [ Time Frame: Up to 64 Weeks ]
    Pecentage of participants with serious infections.


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and Adult participants with Crohn's disease (CD) in Japan.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023030


Contacts
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Contact: AbbVie GK Clinical Trial Registration Desk +81-3-4577-1111 abbvie_jpn_info_clingov@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT06023030    
Other Study ID Numbers: P24-080
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Crohn's disease
Upadacitinib
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases