Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal (READ-UC)

• ClinicalTrials.gov Identifier: NCT04156672
• Recruitment Status: Withdrawn
• First Posted: November 7, 2019
• Last Update Posted: January 27, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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

Study Design

• 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

Groups and Cohorts

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04156672
• Other Study ID Numbers: A3921353; READ UC ( Other Identifier: Alias Study Number )
• First Posted: November 7, 2019
• 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:

Colitis; Colitis, Ulcerative; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Inflammatory Bowel Diseases