Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062354) titled 'Evaluation of Extended Ustekinumab Dosing Intervals for Remission Maintenance in Refractory Ulcerative Colitis' on Aug. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Osaka Medical and Pharmaceutical University

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

Objective: Narrative objectives1 - Ustekinumab (UST) is a monoclonal antibody targeting the p40 subunit shared by interleukin (IL)-12 and IL-23. Following induction therapy, patients transition to maintenance therapy with subcutaneous UST administered every 8 or 12 weeks, beginning 8 weeks after the initial intravenous infusion. Because the clinical remission rate at week 8 was less than 20% in the phase III trial, most patients in routine clinical practice initially receive maintenance therapy every 8 weeks, with extension to every 12 weeks considered after stable disease control has been achieved. However, evidence regarding the efficacy and safety of extending the UST dosing interval, as well as predictors of successful interval extension, remains limited in patients with ulcerative colitis. The aim of this prospective study is to evaluate the efficacy and safety of extending the UST maintenance dosing interval from every 8 weeks to every 12 weeks in patients with ulcerative colitis. In addition, the study will investigate the success rate of dosing interval extension and identify predictors associated with successful interval extension. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The maintenance dosing interval of UST 90 mg per dose subcutaneous injection will be extended from every 8 weeks to every 12 weeks. Interventions/Control_2 - UST 90 mg per dose subcutaneous injection will be continued every 8 weeks as maintenance therapy.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with ulcerative colitis UC receiving maintenance therapy with subcutaneous UST 90 mg every 8 weeks will be included. Eligible patients must achieve clinical remission and mucosal healing one year after initiation of UST therapy. Mucosal healing is defined as endoscopic Mayo score 0 or 1 and fecal calprotectin level <=240 ug/g. Key exclusion criteria - Patients younger than 20 years of age will be excluded. Target Size - 30

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2021 Year 09 Month 03 Day Date of IRB - 2021 Year 09 Month 03 Day Anticipated trial start date - 2021 Year 09 Month 14 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071357

Disclaimer: Curated by HT Syndication.