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| ID | Type | Description | Link |
|---|---|---|---|
| READ UC | Other Identifier | Alias Study Number |
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Study was cancelled due to reclassification of study design. No subjects enrolled in the study.
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This study aims to characterize the Portuguese population of patients with moderate-to-severe UC receiving advanced therapies, by describing clinical and sociodemographic characteristics, and remission outcomes . The clinical, biochemical, endoscopic, and histological outcomes will also be described, as well as frequency of selected EIM, comorbidities and the uptake of preventive care measures and hospitalizations .
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission | - percentage of participants with both a Mayo stool frequency subscore of 0 or 1 and Mayo rectal bleeding subscore of 0 , and a Faecal Calprotectin concentrations < to the cut-off concentration of 150-200 μg/g | at baseline |
| Demographics and clinical characteristics of Ulcerative Colitis participants |
| till baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration | at baseline | |
| Proportion of Ulcerative Colitis participants with symptomatic remission |
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Inclusion Criteria:
Exclusion Criteria:
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Patients followed at Portuguese gastroenterology services, presenting moderate-to-severe Ulcerative Colitis and receiving advanced therapies (i.e., anti-TNF or anti-integrin or JAK inhibitors drugs) for at least 16 weeks.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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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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| at baseline |
| Duration of symptomatic remission | since initiation symptomatic remission till baseline |
| Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g | at baseline |
| Proportion of participants with steroid use | at baseline |
| Total time without steroids since initiation of current advanced therapy | since initiation current advanced therapy till baseline |
| Proportion of participants in steroid-free remission | at baseline |
| Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay | since initiation current advanced therapy till baseline |
| Frequency and incidence of hospitalizations and emergency visits | since initiation current adavnced therapy till baseline |
| Frequency of registered preventive care measures | in the 12 months prior initiation current advanced therapy till baseline |
| Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations | till baseline |
| Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities | till baseline |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |