Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease
NCT ID: NCT06780683
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
174 participants
OBSERVATIONAL
2024-01-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Crohn's disease
Upadacitinib
Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease).
Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.
ulcerative colitis
Upadacitinib
Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease).
Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.
Interventions
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Upadacitinib
Induction Therapy: The dose of upadacitinib for induction therapy is 45mg once daily for a duration of 8 weeks (for ulcerative colitis) or 12 weeks (for Crohn's disease).
Maintenance Therapy: The dose of upadacitinib for maintenance therapy is 15mg once daily; for patients with refractory, severe, or extensive disease, a maintenance dose of 30mg once daily may be considered.
Eligibility Criteria
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Inclusion Criteria
* Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent.
Exclusion Criteria:
* Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.
ALL
No
Sponsors
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Xiang Gao
OTHER
Responsible Party
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Xiang Gao
Director of Gastroenterology
Locations
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The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
The Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Haiyan Zhang
Role: backup
Xiang Gao
Role: backup
Taofeng Jiang
Role: backup
Xiaoling Wang
Role: backup
Yun He
Role: backup
Tao Zhang
Role: backup
References
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Loftus EV Jr, Panes J, Lacerda AP, Peyrin-Biroulet L, D'Haens G, Panaccione R, Reinisch W, Louis E, Chen M, Nakase H, Begun J, Boland BS, Phillips C, Mohamed MF, Liu J, Geng Z, Feng T, Dubcenco E, Colombel JF. Upadacitinib Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2023 May 25;388(21):1966-1980. doi: 10.1056/NEJMoa2212728.
Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26.
Other Identifiers
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2024ZSLYEC-250
Identifier Type: -
Identifier Source: org_study_id
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