Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal (READ-UC)
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ClinicalTrials.gov Identifier: NCT04156672 |
Recruitment Status :
Withdrawn
(Study was cancelled due to reclassification of study design. No subjects enrolled in the study.)
First Posted : November 7, 2019
Last Update Posted : January 27, 2021
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Condition or disease |
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Ulcerative Colitis |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | REal-world Study of the Clinical Profile and Treatment Outcomes of Advanced Therapies for Ulcerative Colitis in Portugal-READ UC |
Estimated Study Start Date : | October 6, 2020 |
Estimated Primary Completion Date : | April 30, 2021 |
Estimated Study Completion Date : | April 30, 2021 |

- Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission [ Time Frame: at baseline ]- 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
- Demographics and clinical characteristics of Ulcerative Colitis participants [ Time Frame: till baseline ]
- percentage of gender distribution, age distribution, smoking status distribution, height and weight distribution, BMI distribution
- percentage of Ulcerative Colitis extend and severity (Montreal criteria) distribution, percentage of prior acute severe Ulcerative Colitis, percentage of clinical relapses
- Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration [ Time Frame: at baseline ]
- Proportion of Ulcerative Colitis participants with symptomatic remission [ Time Frame: at baseline ]
- Duration of symptomatic remission [ Time Frame: since initiation symptomatic remission till baseline ]
- Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g [ Time Frame: at baseline ]
- Proportion of participants with steroid use [ Time Frame: at baseline ]
- Total time without steroids since initiation of current advanced therapy [ Time Frame: since initiation current advanced therapy till baseline ]
- Proportion of participants in steroid-free remission [ Time Frame: at baseline ]
- Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay [ Time Frame: since initiation current advanced therapy till baseline ]
- Frequency and incidence of hospitalizations and emergency visits [ Time Frame: since initiation current adavnced therapy till baseline ]
- Frequency of registered preventive care measures [ Time Frame: 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 [ Time Frame: till baseline ]
- Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities [ Time Frame: till baseline ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156672
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT04156672 |
Other Study ID Numbers: |
A3921353 READ UC ( Other Identifier: Alias Study Number ) |
First Posted: | November 7, 2019 Key Record Dates |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |