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
| NCT ID | NCT06023030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AbbVie |
| Condition | Crohn's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-07-28 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2023-07-28 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT06023030 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06023030 currently recruiting?
Yes, NCT06023030 is actively recruiting participants. Contact the research team at abbvie_jpn_info_clingov@abbvie.com for enrollment information.
Where is the NCT06023030 trial being conducted?
This trial is being conducted at Anjo-shi, Japan, Handa, Japan, Nagakute, Japan, Nagoya, Japan and 11 additional locations.
Who is sponsoring the NCT06023030 clinical trial?
NCT06023030 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 240 participants.
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