Vedolizumab in ulcerative colitis Japanese patients

Not Applicable

Completed

• Conditions: lcerative Colitis

• Registration Number: JPRN-jRCT1080225363
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

This study showed the efficacy and safety of Vedolizumab in the introduction and maintenance phases for patients with ulcerative colitis administered to Vedolizumab.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-26
• Study Completion: 2021-06-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

1. Patient initiated VDZ IV treatment (at least one infusion) as per label indication in Japan between December 1st, 2018 and February 29th, 2020
2. Female or male patient with a confirmed diagnosis of moderately to severely active UC
3. Patient aged 20 years or older at index event
4. Patient has medical information available from the date of UC diagnosis

Exclusion Criteria

1. Patient that received VDZ IV as part of clinical trial or interventional clinical study at index event
2. Patient enrolled in another Inflammatory Bowel Disease (IBD) clinical trial or interventional clinical study at index event
3. Partial Mayo score is missing at baseline
4. Patient initiated VDZ IV treatment as combination therapy with another biologic agent
5. Patient initiated VDZ IV treatment at another institution (patient's medical information is not precisely accessible)
6. Patient requested to opt-out of his or her medical information

Study & Design

• Study Type: Observational
• Study Design: Not specified