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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan
Overview
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.
Primary outcome measures
- Percentage of Participants with Drug Related Serious Infections [Time frame: Up to 64 Weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 104 centers
- Anjou Kousei Hospital /ID# 261872 — Anjo-shi
- Handa City Hospital /ID# 270446 — Handa
- Aichi Medical University Hospital /ID# 261871 — Nagakute
- Masuko Memorial Hospital /ID# 267420 — Nagoya
- Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219 — Nagoya
- Nagoya City University Hospital /ID# 275588 — Nagoya
- Toyohashi Municipal Hospital /ID# 274975 — Toyohashi
- Ieda Hospital /ID# 259754 — Toyota-shi
- … and 96 more centers
Identifiers
NCT: NCT06023030 · P24-080