An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Velsipity.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC). Basic parameters: from 0 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Velsipity® Tablets 2 mg Special Investigation (Investigation on Long-Term Use in Patients With Ulcerative Colitis)
Overview
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.
Interventions
- Drug Velsipity
2 milligrams(mg) tablet as provided in real world practice
Primary outcome measures
- The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions) [Time frame: Up to 52 weeks]
Secondary outcome measures (1)
- Percentage of Participants With Symptomatic Remission [Time frame: 12 weeks and 52 weeks]
Eligibility criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Pfizer — Tokyo
Identifiers
NCT: NCT07459686 · C5041036