An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis
ConditionUlcerative Colitis (UC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Velsipity
Drug2 milligrams(mg) tablet as provided in real world practice
Treatment groups
553 Participants
are divided into 1 treatment groupGroup A: Patients with ulcerative colitis1 intervention
Trial outcomes
Primary outcomes
1
The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions)
Time frame
Up to 52 weeksSecondary outcomes
1
Percentage of Participants With Symptomatic Remission
Time frame
12 weeks and 52 weeks Source ClinicalTrials.gov