Clinical trial
A Retrospective Analysis of the Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease
Name
2024ZSLYEC-063
Description
This study focuses on evaluating Upadacitinib, a new oral medication that inhibits specific enzymes involved in inflammation, for treating inflammatory bowel disease (IBD), which includes conditions such as Crohn\'s Disease and Ulcerative Colitis. The goal is to determine how effective and safe this drug is for patients in China, where data is currently lacking.IBD significantly affects individuals\' quality of life and imposes a high burden on society and healthcare systems. Current treatments don\'t work for everyone, and some patients may need surgery. Upadacitinib has shown promise in other countries for treating IBD and related conditions and has been approved by the US FDA for such use.
Our study is retrospective and multicenter, meaning it will look back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib. Investigators aim to enroll patients treated between January 2020 and December 2023, focusing on adults who have taken Upadacitinib for at least 8 weeks.For patients, families, and healthcare providers, this research could mean a potential new treatment option for IBD. Understanding Upadacitinib\'s efficacy and safety could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life for those affected by IBD. The ultimate goal is to provide more personalized and effective treatment strategies for IBD patients in China.
Trial arms
Trial start
2021-01-01
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Completed
Treatment
Upadacitinib
Upadacitinib, a selective Janus kinase (JAK) inhibitor taken orally, is being assessed for its unique capacity to attenuate inflammatory pathways in IBD at a cellular level by selectively inhibiting JAK1, a pathway integral to inflammatory cytokine production. This study focuses on its use as monotherapy for Chinese patients unresponsive to conventional IBD treatments, such as aminosalicylates and corticosteroids. By centering on a demographic typically underrepresented in research, the study aims to provide new insights into dosing, treatment frequency, and duration, thus enhancing the understanding of Upadacitinib\'s safety and efficacy. The retrospective analysis of patient data is anticipated to inform more personalized treatment approaches, potentially improving IBD management and patient quality of life.
Size
81
Primary endpoint
Steroid-Free Clinical Remission
CD:Assessed at 12 weeks and up to 24 weeks; UC：Assessed at 8weeks and up to 24 weeks
Eligibility criteria
Inclusion Criteria:
* Patients who were hospitalized in our institution or its branches between January 2020 and September 2023.
Patients with a confirmed diagnosis of Crohn\'s Disease (CD) or Ulcerative Colitis (UC).
Patients aged 18 years or older. Patients who have received at least 8 weeks of Upadacitinib treatment prior to December 2023.
Exclusion Criteria:
* Patients with an unclear diagnosis. Patients under the age of 18. Patients who have been treated with Upadacitinib for less than 8 weeks.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 81, 'type': 'ACTUAL'}}
Updated at
2024-02-23
1 organization
1 product
1 indication
Product
UpadacitinibIndication
Inflammatory Bowel Disease