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

A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06023030

Enrollment

240

Registered

2023-09-05

Start date

2023-07-28

Completion date

2027-05-01

Last updated

2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's disease, Upadacitinib

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants with Drug Related Serious Infections	Up to 64 Weeks	Pecentage of participants with serious infections.

Countries

Japan

Contacts

CONTACTAbbVie GK Clinical Trial Registration Desk

abbvie_jpn_info_clingov@abbvie.com+81-3-4577-1111

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results