An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis
Velsipity® Tablets 2 mg Special Investigation (Investigation on Long-Term Use in Patients With Ulcerative Colitis)
1 other identifier
observational
553
1 country
1
Brief Summary
A study to assess the safety and effectiveness of Velsipity Tablets 2 mg during long-term treatment (up to a maximum of 52 weeks) in patients with ulcerative colitis under actual medical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedStudy Start
First participant enrolled
April 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 29, 2029
May 18, 2026
May 1, 2026
2.8 years
March 5, 2026
May 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions)
Up to 52 weeks
Secondary Outcomes (1)
Percentage of Participants With Symptomatic Remission
12 weeks and 52 weeks
Study Arms (1)
Patients with ulcerative colitis
Patients taking velsipity
Interventions
2 milligrams(mg) tablet as provided in real world practice
Eligibility Criteria
Patients with moderate to severe ulcerative colitis for whom treatment with this drug was started for the first time after the contract date for this study.
You may qualify if:
- Patients with moderate to severe ulcerative colitis for whom treatment with this drug was started for the first time after the contract date for this study. Patients who have participated in a clinical study of this drug in the past or patients who have participated in this study are excluded.
- Patients who understand the contents of this study and give consent to provision of the information collected in this study to third parties and the use of it for other purposes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 10, 2026
Study Start
April 27, 2026
Primary Completion (Estimated)
January 29, 2029
Study Completion (Estimated)
January 29, 2029
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.