Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061165) titled 'Investigation of treatment effects, biomarkers and safety of S1P modulators for the induction of clinical response and remission in patients with ulcerative colitis in Japanese tertiary center: SPRINTER study' on June 30.
Study Type:
Observational
Primary Sponsor:
Institute - Saitama Medical Center, Saitama Medical University
Condition:
Condition - ulcerative colitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This prospective observational study will evaluate the therapeutic efficacy, biomarkers, and safety of S1P receptor modulators, including OZM and ETR, in patients with moderate to severe active or remission 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 - Ulcerative colitis patients aged 18 or older scheduled for treatment with OZM or ETR in our department
Key exclusion criteria - Patients with allergy of OZM or ETR
Patients deemed unsuitable for this study by a physician
Target Size - 150
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 06 Month 04 Day
Date of IRB - 2026 Year 06 Month 02 Day
Anticipated trial start date - 2026 Year 06 Month 05 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=R000069996
Disclaimer: Curated by HT Syndication.
