Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease (EaseUpIBD)
January 13, 2025 updated by: Xiang Gao
Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: a Multicenter, Single-Arm, Prospective, Observational Real-World Study
Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments.
However, nearly half of the patients are either primary or secondary non-responders to the existing biologics.
Upadacitinib is the only oral small molecule targeted drug approved for IBD in China.
There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population.
This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
174
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lang Lin
- Phone Number: +86-020-38663423
- Email: linlang3@mail.sysu.edu.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510655
- Recruiting
- Sixth Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Xiang Gao
-
Contact:
- Xiang Gao
- Phone Number: +86-020-38663423
- Email: gxiang@mail.sysu.edu.cn
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
-
Contact:
- Haiyan Zhang
-
Contact:
- Haiyan, Zhang
- Phone Number: +86-020-81887233
- Email: zhanghaiyan128@126.com
-
Meizhou, Guangdong, China, 514000
- Recruiting
- Meizhou People's Hospital
-
Contact:
- Taofeng Jiang
- Phone Number: +86-0753-2202723
- Email: jtf18@163.com
-
Contact:
- Taofeng Jiang
-
Shenzhen, Guangdong, China, 518000
- Recruiting
- The Eighth Affiliated Hospital, Sun Yat-Sen University
-
Contact:
- Xiaoling Wang
- Phone Number: +86-0755-83982222
- Email: wangxling@mail.sysu.edu.cn
-
Contact:
- Xiaoling Wang
-
-
Guangxi
-
Liuzhou, Guangxi, China, 545000
- Recruiting
- Liuzhou People's Hospital
-
Contact:
- Yun He
- Phone Number: +86-0772-3612345
- Email: 2997835155@qq.com
-
Contact:
- Yun He
-
Nanning, Guangxi, China, 530000
- Recruiting
- Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
-
Contact:
- Tao Zhang
-
Contact:
- Tao Zhang
- Phone Number: +86-0771-2188018
- Email: ruikangec@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population was derived from IBD centers in China.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Crohn's disease
|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Remission Rate
Time Frame: 52 weeks
|
Clinical remission rate in patients with ulcerative Colitis or Crohn's Disease.
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Lancet. 2022 Sep 24;400(10357):996. doi: 10.1016/S0140-6736(22)01069-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
January 13, 2025
First Submitted That Met QC Criteria
January 13, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 13, 2025
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024ZSLYEC-250
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.