Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal
NCT04156672
ABOUT THIS STUDY
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- Aged at least 18 years old
- Diagnosed with Ulcerative Colitis, confirmed by a gastroenterologist
- Treated with anti-TNF or anti-integrin or JAK inhibitors drugs for at least 16 weeks
- Followed at one of the participating centers when initiating and during the current treatment
- Signed informed consent
- Treated with anti-TNF or anti-integrin or JAK inhibitors drugs at induction phase
- Enrolled in randomized clinical trials or other experimental studies in the last 12
months prior to initiation of advanced therapy
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Descriptive Information | |||||
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Brief Title | Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal | ||||
Official Title | REal-world Study of the Clinical Profile and Treatment Outcomes of Advanced Therapies for Ulcerative Colitis in Portugal-READ UC | ||||
Brief Summary | 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 . | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Cross-Sectional | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | 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. | ||||
Condition | Ulcerative Colitis | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Not yet recruiting | ||||
Estimated Enrollment | 310 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | September 30, 2020 | ||||
Estimated Primary Completion Date | September 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04156672 | ||||
Other Study ID Numbers | A3921353 READ UC ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | November 2019 |