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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with ulcerative colitis | Patients taking velsipity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velsipity | Drug | 2 milligrams(mg) tablet as provided in real world practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of serious infections (adverse events and adverse drug reactions) and safety specifications (adverse drug reactions) | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Symptomatic Remission | 12 weeks and 52 weeks |
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Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Recruiting | Tokyo | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000656249 | etrasimod |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |