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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis

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 Type: Observational
• Enrollment (Actual): 465

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Crohn's & Colitis Foundation
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7555
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population: participants in IBD Partners or SPARC cohort.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Crohn's Disease (Vedolizumab); Participants with Crohn's disease (CD) who reported taking vedolizumab.
Crohn's Disease (Ustekinumab); Participants with Crohn's disease (CD) who reported taking ustekinumab.
Ulcerative Colitis (Vedolizumab); Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
Ulcerative Colitis (Tofacitinib); Participants with Ulcerative colitis (UC) who reported taking tofacitinib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (poorer health).	Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
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 (poorer health).	Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Index Medication Persistence	Medication persistence was defined as continuing index medication.	4-10 months after medication initiation
Number of Participants Using Corticosteroids at Follow-Up	Participants who reported using corticosteroids.	4-10 months after medication initiation
Short Crohn's Disease Activity Index (sCDAI)	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.	Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Mayo Clinic Score	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.	Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
PROMIS Social Satisfaction Score	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.	Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Patient-Centered Outcomes Research Institute; Crohn's and Colitis Foundation
• Investigators: Principal Investigator: Michael Kappelman, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2019
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 19-0273; PaCR-2017C2-8172-IC (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No