Tokyo, April 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060721) titled 'Real world investigation of Guselukmab induction and maintenance efficacy and safety for the patients with ulcerative colitis in Japanese tertiary center : REGALIA study' on April 30.
Study Type:
Observational
Primary Sponsor:
Institute - Saitama Medical University
Condition:
Condition - ulcerative colitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to establish the optimization of guselkumab treatment by prospectively examining the efficacy and safety, including the continuation rate, of guselkumab infusion and subcutaneous injection formulations in patients with ulcerative colitis.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients aged 18 years or older with ulcerative colitis who are scheduled to be treated with guselkumab in our department
Key exclusion criteria - 1) Patients who are allergic to guselkumab
2) Patients who are deemed inappropriate for this study by a physician
Target Size - 100
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 04 Month 02 Day
Date of IRB - 2026 Year 04 Month 02 Day
Anticipated trial start date - 2026 Year 04 Month 02 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069469
Disclaimer: Curated by HT Syndication.
