Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohn's Disease

NCT06446219 | Completed

• 1 other identifier: 2024ZSLYEC-257
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on Upadacitinib, a new oral and small-molecular medication that inhibits specific enzymes involved in inflammation. The goal is to determine efficacy and safety of Upadacitinib for Crohn's Disease patients in China compared with Vedolizumab, which is used to inhibit recruitment of inflammatory cells. Crohn's Disease 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 Crohn's Disease and related conditions, and has been approved by the US FDA for such use. The investigators' retrospective and multicenter study looks back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib and Vedolizumab. Investigators aim to enroll patients treated between January 2020 and March 2024, who received follow-up for more than 12 weeks. For patients, families, and healthcare providers, this research could provide a potential new treatment option for Crohn's Disease. Better efficacy and safety of Upadacitinib than Vedolizumab could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life. The ultimate goal is to provide more personalized and effective treatment strategies for Crohn's Disease patients in China.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Steroid-Free Clinical Remission

  Steroid-Free Clinical Remission in Crohn's Disease is defined as a Crohn's disease activity index(CDAI) score of less than 150, achieved without the use of corticosteroids.

  Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;

Secondary Outcomes (7)

• Clinical Remission

  Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;

• Clinical Response

  Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;

• Endoscopic Remission

  Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;

• Endoscopic Response

  Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;

• Mucosal Healing

  Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;

Study Arms (2)

Upadacitinib(UPA)

Upadacitinib, a selective Janus kinase (JAK) inhibitor taken orally, is being assessed for its unique capacity to attenuate inflammatory pathways in Crohn's Disease at a cellular level by selectively inhibiting Janus kinase(JAK)1, a pathway integral to inflammatory cytokine production. This study focuses on its use as main therapy for Chinese patients unresponsive to conventional Crohn's Disease treatments, such as tumor necrosis factor-α inhibitor. Rinvoq is the marketed drugs for clinical use, whose oral dosage is 45 mg per day during the induction period and 15 mg/30 mg per day during maintenance period, and the induction period would last for 8 weeks.

Vedolizumab(VDZ)

Vedolizumab, a monoclonal antibody targeting integrin α4β7, is used to inhibit recruitment of inflammatory cells. This drug is always used as second-line treatment for patients with moderate-to-severe active stage Crohn's Disease who fail to respond to conventional treatments such as tumor necrosis factor-α inhibitor. This study uses Vedolizumab as control group to illustrate the efficacy and safety of Upadacitinib in second-line treatment for Crohn's Disease. Entyvio is the marketed drugs for clinical use, should be given intra-arterially in week 0, 2, 6 and every subsequent 8 weeks.

Eligibility Criteria

• Age: 18 Years - 75 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 between January 2020 and March 2024 at our institution or its branches, and who have been received follow-up for no less than 12 weeks prior to March 2024. The study population should also failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab). The focus is on adults with a confirmed diagnosis to assess the efficacy in inducing clinical remission and altering disease progression. Exclusion criteria include unclear diagnosis, patients under 18, previously using Upadacitinib/Vedolizumab and absence of clinical data, 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 March 2024.
• Patients aged 18 years or older.
• Confirmed as moderately-to-severely active Crohn's disease according to Chinese clinical practice guideline on the management of Crohn's disease (2023,Guangzhou).
• Failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab).
• Follow-up time for no less than 12 weeks.

You may not qualify if:

• Patients who have previously used Upadacitinib and Vedolizumab.
• With insufficient clinical data at baseline, 12 weeks in the Upadacitinib group and 14 weeks in the Vedolizumab group to evaluate the efficacy.

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

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 6, 2024
• Study Start: January 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)