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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Recruitment Status : Withdrawn (Study was cancelled due to reclassification of study design.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

Tracking Information
First Submitted Date October 24, 2019
First Posted Date November 7, 2019
Last Update Posted Date January 27, 2021
Estimated Study Start Date October 6, 2020
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 6, 2019)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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 Withdrawn
Actual Enrollment
 (submitted: January 25, 2021)
0
Original Estimated Enrollment
 (submitted: November 6, 2019)
310
Estimated Study Completion Date April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
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
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021