Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059341) titled 'A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)' on Oct. 8.

Study Type: Observational

Primary Sponsor: Institute - AbbVie GK

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

Objective: Narrative objectives1 - The clinical effectiveness of risankizumab in patients with moderate to severe ulcerative colitis in real-world clinical practice Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 15 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - -Male or female patients 15 years of age or older. -Participants with a diagnosis of moderate to severe UC commenced on Risankizumab treatment prescribed as part of their routine clinical care at their clinical's discretion according to Japan approved label and treatment prescription recommendations/guidelines. -The decision to prescribe RZB is made prior to and independently of study participation. -Participants able to provide voluntary informed consent before any study-related activities or procedures. If the patient is under 18 years old, a patient's parent or legal guardian must be willing to give written informed consent. -Participants who can understand and communicate with the investigator and comply with the requirements of the study, including collection of PRO data using a smart device (i.e., mobile phone). -Participants without previous exposure to RZB. -Participants who are not currently participating in interventional research. Key exclusion criteria - No formal Exclusion criteria exist Target Size - 200

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 12 Month 18 Day Date of IRB - 2025 Year 08 Month 05 Day Anticipated trial start date - 2025 Year 09 Month 30 Day Last follow-up date - 2030 Year 02 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067805

Disclaimer: Curated by HT Syndication.