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

Completed

• Conditions: Crohn's Disease; Ulcerative Colitis

• Registration Number: NCT04852666
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Study Start: 2019-07-25
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-21
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Results First Submitted: 2023-03-22
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Results First Posted: 2024-06-14
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 465

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.

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Exclusion Criteria

• less than 18 years of age

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROMIS Measures of Pain Interference	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).
PROMIS Measures of Fatigue	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 Outcome Measures

Name	Time	Method
Number of Participants Using Corticosteroids at Follow-Up	4-10 months after medication initiation	Participants who reported using corticosteroids.
Mayo Clinic Score	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.
Number of Participants With Index Medication Persistence	4-10 months after medication initiation	Medication persistence was defined as continuing index medication.
Short Crohn's Disease Activity Index (sCDAI)	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.
PROMIS Social Satisfaction Score	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.

Trial Locations

Locations (2)

Crohn's & Colitis Foundation; 🇺🇸 New York, New York, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States