Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease

NCT06274996 | Completed

• 1 other identifier: 2024ZSLYEC-063
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Steroid-Free Clinical Remission

  Clinical remission in CD is defined as a CDAI score of less than 150, achieved without the use of corticosteroids.Clinical remission in UC is defined as a modified Mayo score of 2 or less, with no individual subscore greater than 1, achieved without the use of corticosteroids.

  CD:Assessed at 12 weeks and up to 24 weeks; UC：Assessed at 8weeks and up to 24 weeks

Secondary Outcomes (5)

• Clinical Response

  CD:Assessed at 12 weeks and up to 24 weeks; UC：Assessed at 8 weeks and up to 24 weeks

• Endoscopic Remission

  CD:Assessed at 12 weeks and up to 24 weeks; UC：Assessed at 8 weeks and up to 24 weeks

• Mucosal Healing

  CD:Assessed at 12 weeks and up to 24 weeks; UC：Assessed at 8 weeks and up to 24 weeks

• Radiological remission

  CD:Assessed at 12 weeks and up to 24 weeks; UC：Assessed at 8 weeks and up to 24 weeks

• Radiological response

  CD:Assessed at 12 weeks and up to 24 weeks; UC：Assessed at 8 weeks and up to 24 weeks

Interventions

Upadacitinib DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises patients aged 18 and older who were hospitalized for Crohn\'s Disease (CD) or Ulcerative Colitis (UC) between January 2020 and September 2023 at our institution or its branches, and who have been treated with Upadacitinib for at least 8 weeks prior to December 2023. The focus is on adults with a confirmed diagnosis to assess the treatment\'s efficacy in inducing clinical remission and altering disease progression. Exclusion criteria include unclear diagnosis, patients under 18, and Upadacitinib treatment for less than 8 weeks, ensuring a uniform group for valid results.

You may qualify if:

• 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.

You may not qualify if:

• Patients with an unclear diagnosis. Patients under the age of 18. Patients who have been treated with Upadacitinib for less than 8 weeks.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 23, 2024
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)