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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04852666
Collaborator
Patient-Centered Outcomes Research Institute (Other), Crohn's & Colitis Foundation (Other)
900
Enrollment
2
Locations
39.7
Anticipated Duration (Months)
450
Patients Per Site
11.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    900 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jul 25, 2019
    Anticipated Primary Completion Date :
    Nov 15, 2022
    Anticipated Study Completion Date :
    Nov 15, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    IBD Partners cohort

    IBD Partners is an internet-based cohort study of patients with Crohn's disease (CD) and ulcerative colitis (UC). It is coordinated by the University of North Carolina School of Medicine in conjunction with the Crohn's & Colitis Foundation. There is no intervention for this study.
    SPARC-IBD cohort

    SPARC-IBD is a multi-center cohort study of patients with Crohn's disease (CD) and ulcerative colitis (UC). It is coordinated by the Crohn's & Colitis Foundation. There is no intervention for this study.

    Outcome Measures

    Primary Outcome Measures

    1. PROMIS measures of pain interference [4-10 months after medication initiation]

      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.

    2. PROMIS measures of fatigue [4-10 months after medication initiation]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Crohn's & Colitis Foundation New York New York United States 10017
    2 University of North Carolina Chapel Hill North Carolina United States 27599-7555

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill
    • Patient-Centered Outcomes Research Institute
    • Crohn's & Colitis Foundation

    Investigators

    • Principal Investigator: Michael Kappelman, MD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT04852666
    Other Study ID Numbers:
    • 19-0273
    • PaCR-2017C2-8172-IC
    First Posted:
    Apr 21, 2021
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Crohn Disease
    Colitis
    Colitis, Ulcerative
    Ulcer

    Study Results

    No Results Posted as of Apr 7, 2022