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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06023030

Collaborator

(none)

240

Enrollment

Locations

40.1

Anticipated Duration (Months)

120

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Crohn's Disease

Study Design

Study Type:

Observational

Anticipated 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 :

Jul 28, 2023

Anticipated Primary Completion Date :

Nov 30, 2026

Anticipated Study Completion Date :

Nov 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Upadacitinib Participants will receive upadacitinib as prescribed by their physician according to local label.

Outcome Measures

Primary Outcome Measures

Percentage of Participants with Drug Related Serious Infections [Up to 64 Weeks]
Pecentage of participants with serious infections.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Ieda Hospital /ID# 259754	Toyota-shi	Aichi	Japan	470-1219
2	Yokkaichi Hazu Medical Center /ID# 260140	Yokkaichi-shi	Mie	Japan	510-0016

Sponsors and Collaborators

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

AbbVie

ClinicalTrials.gov Identifier:

NCT06023030

Other Study ID Numbers:

P24-080

First Posted:

Sep 5, 2023

Last Update Posted:

Sep 5, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by AbbVie

Crohn's disease

Upadacitinib

Additional relevant MeSH terms:

Crohn Disease

Study Results

No Results Posted as of Sep 5, 2023