Ulcerative Colitis (UC)
Conditions
Keywords
Etrasimod, Velsipity, Ulcerative Colitis, UC
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.
Interventions
DRUGVelsipity
2 milligrams(mg) tablet as provided in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. 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. 2. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions) | Up to 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Symptomatic Remission | 12 weeks and 52 weeks |
Countries
Japan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed