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Completed

NCT Number: NCT04852666

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

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.

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Key information

Conditions

Crohn's Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Crohn's & Colitis Foundation, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age greater than or equal to 18;
  • diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort);
  • 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

Treatment and study plan

Primary outcomes

  1. PROMIS Measures of Pain Interference

    Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

    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 (poorer health).

  2. PROMIS Measures of Fatigue

    Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

    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 (poorer health).

Secondary outcomes

  1. Number of Participants With Index Medication Persistence

    Time frame: 4-10 months after medication initiation

    Medication persistence was defined as continuing index medication.

  2. Number of Participants Using Corticosteroids at Follow-Up

    Time frame: 4-10 months after medication initiation

    Participants who reported using corticosteroids.

  3. Short Crohn's Disease Activity Index (sCDAI)

    Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

    Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patients' symptoms using only a questionnaire, which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, stool frequency, and general well-being reported as a total score. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI with scores ranging from 0 to 600, such that scores,<150 define remission, 150 to 219 mild activity, 220 to 450 moderate activity, and greater than 450 severe activity.

  4. Mayo Clinic Score

    Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

    The Mayo Clinic Score (MCS) asks 2 questions about (1) stool frequency and (2) rectal bleeding with an overall score range (0-6). Higher scores reflect more disease symptomatology.

  5. PROMIS Social Satisfaction Score

    Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

    NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of social satisfaction. 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 for social satisfaction indicates better health.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Crohn's and Colitis Foundation
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: COMPARE

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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