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NCT04852666 Clinical Trial

Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)

Ulcerative Colitis Clinical Trial

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Official title:
Comparative Effectiveness of Biologics or Small Molecule Therapies After Failure of Anti-TNF Treatment in Patients With Crohn's Disease and Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04852666
Other study ID # 19-0273
Secondary ID PaCR-2017C2-8172
Status Completed
Phase
First received
Last updated
Start date July 25, 2019
Est. completion date December 15, 2022

Study information
Verified date April 2022
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.

Description:

This study is a secondary analysis using data from participants in the IBD Partners and SPARC-IBD cohorts. Data received from IBD Partners consists of patient-reported outcomes gathered via online surveys (baseline and 6-month follow-ups). Data received from SPARC-IBD consists of patient-reported outcomes gathered via surveys (baseline and follow-ups) as well as data from clinical records.

Recruitment information / eligibility
Status Completed
Enrollment 900
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age greater than or equal to 18; - diagnosis of CD or UC (as reported by participant for IBD Partners and/or physician for SPARC); - initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib. Exclusion Criteria: - less than 18 years of age

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of North Carolina Chapel Hill North Carolina
United States Crohn's & Colitis Foundation New York New York

Sponsors (3)
Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Crohn's and Colitis Foundation, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PROMIS measures of pain interference NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference. 4-10 months after medication initiation
Primary PROMIS measures of fatigue NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue. 4-10 months after medication initiation
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