Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062396) titled 'Study of Oral 5-ASA Discontinuation in Patients with Ulcerative Colitis Who Have Achieved Mucosal Healing' on July 29.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Ehime Prefectural Central Hospital

Condition: Condition - Ulcerative Colitis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy and safety of discontinuing oral 5-aminosalicylic acid (5-ASA) compared with continuing oral 5-ASA in patients with ulcerative colitis who have achieved endoscopic mucosal healing with Advanced Therapy. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continue oral 5-aminosalicylic acid while maintaining Advanced Therapy. Interventions/Control_2 - Discontinue oral 5-aminosalicylic acid while maintaining Advanced Therapy.

Eligibility: Age-lower limit - 16 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Patients aged 16 years or older with a diagnosis of ulcerative colitis. 2) Receiving oral 5-aminosalicylic acid. 3) Receiving maintenance therapy with an advanced therapy approved for ulcerative colitis in Japan. 4) No systemic or topical corticosteroid use for at least 8 weeks before enrollment. 5) No changes in the type, dose, or dosing interval of oral 5-ASA or advanced therapy for at least 8 weeks before enrollment. 6) Clinical remission maintained for at least 8 weeks before enrollment (Partial Mayo Score of 1 or less and Rectal Bleeding Subscore =0). 7) Endoscopic mucosal healing (Mayo Endoscopic Subscore of 1 or less) confirmed within 8 weeks before enrollment. 8) Written informed consent obtained. Key exclusion criteria - 1) Refusal or inability to provide written informed consent. 2) Age younger than 16 years. 3) Pregnant or breastfeeding women. 4) History of total or subtotal colectomy. 5) Patients considered unsuitable for participation by the investigator. Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 15 Day Date of IRB - 2026 Year 07 Month 29 Day Anticipated trial start date - 2026 Year 07 Month 30 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071410

Disclaimer: Curated by HT Syndication.