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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Recruitment Status : Withdrawn (Study was cancelled due to reclassification of study design.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
Sponsor:
Information provided by (Responsible Party):
Pfizer

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 .

Condition or disease
Ulcerative Colitis

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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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
  2. Proportion of Ulcerative Colitis participants with symptomatic remission [ Time Frame: at baseline ]
  3. Duration of symptomatic remission [ Time Frame: since initiation symptomatic remission till baseline ]
  4. Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g [ Time Frame: at baseline ]
  5. Proportion of participants with steroid use [ Time Frame: at baseline ]
  6. Total time without steroids since initiation of current advanced therapy [ Time Frame: since initiation current advanced therapy till baseline ]
  7. Proportion of participants in steroid-free remission [ Time Frame: at baseline ]
  8. Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay [ Time Frame: since initiation current advanced therapy till baseline ]
  9. Frequency and incidence of hospitalizations and emergency visits [ Time Frame: since initiation current adavnced therapy till baseline ]
  10. Frequency of registered preventive care measures [ Time Frame: in the 12 months prior initiation current advanced therapy till baseline ]
  11. Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations [ Time Frame: till baseline ]
  12. Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities [ Time Frame: till baseline ]


Information from the National Library of Medicine

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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
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.
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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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.
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases