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NCT Number: NCT06023030

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anjou Kousei Hospital /ID# 261872, Anjo-shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants with Drug Related Serious Infections

    Time frame: Up to 64 Weeks

    Pecentage of participants with serious infections.

Study contacts

Contact information is provided by the study sponsor or research team.

AbbVie GK Clinical Trial Registration Desk

CONTACT

[email protected]

+81-3-4577-1111

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 5, 2023
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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