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NCT06023030Recruiting

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
AbbVieClinicalTrials.gov
Verified
Study focus
Disease/Condition
Crohn's Disease
Study type
Observational
Sponsor & location
Primary sponsor
AbbVie
Location
Toyota-shi,Yokkaichi-shi,Osaka-shi, Japan
Timeline & enrollment
Phase
N/A
Start date
Jul 28, 2023
End date
Nov 30, 2026
Enrollment
240 participants
Primary outcome

Percentage of Participants with Drug Related Serious Infections

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.

ICD-10 classifications
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06023030
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06023030 through Pure Global AI's free database. This phase not specified trial is sponsored by AbbVie and is currently Recruiting. The study focuses on Crohn's Disease. Target enrollment is 240 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.