Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059301) titled 'Ancillary Study in Outcomes Research for Ulcerative Colitis using Patient Focused Registry' on Oct. 7.
Study Type:
Observational
Primary Sponsor:
Institute - Takeda Pharmaceutical Company, Limited
Condition:
Condition - Ulcerative colitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to clarify the below 4 points leading to the Outcome improvement (patient report type of outcome such as QOL, recurrence and deterioration, hospitalization and remove of the whole large bowel) by using patient-centric registry established in the preceding study, YOURS-001. :
1. To investigate the relationship between lifestyle factors and flare-ups in patients with ulcerative colitis in clinical remission.
2. Comprehensively evaluate changes in patient-reported outcomes (PRO)
Basic objectives2 - Others
Eligibility:
Age-lower limit - 16
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Subjects who fills below requirement
1.Subjects enrolled in the YOURS-001 trial, Outcomes Research for Ulcerative Colitis using Patient Focused Registry, who have agreed to secondary use of their data
Key exclusion criteria - Subjects who meet the following criteria are not eligible for this clinical study.
1. Subjects who are judged as inappropriate by the research institution to participate in this trial
Target Size - 2006
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 05 Month 08 Day
Date of IRB - 2025 Year 08 Month 25 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2025 Year 10 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067828
Disclaimer: Curated by HT Syndication.
