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
• Start date: July 25, 2019
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• 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: 465
• 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 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Ulcer
• Ulcerative Colitis

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 (poorer health).	Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
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 (poorer health).	Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Secondary	Number of Participants With Index Medication Persistence	Medication persistence was defined as continuing index medication.	4-10 months after medication initiation
Secondary	Number of Participants Using Corticosteroids at Follow-Up	Participants who reported using corticosteroids.	4-10 months after medication initiation
Secondary	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)
Secondary	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)
Secondary	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)