Clinical trial NCT04852666: Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Crohn's and Colitis Foundation
First posted: 2021-04-21
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population: participants in IBD Partners or SPARC cohort.

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.

Eligibility criteria: 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

Primary outcomes:
measure: PROMIS Measures of Pain Interference
timeFrame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
measure: PROMIS Measures of Fatigue
timeFrame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Secondary outcomes:
measure: Number of Participants With Index Medication Persistence
timeFrame: 4-10 months after medication initiation
measure: Number of Participants Using Corticosteroids at Follow-Up
timeFrame: 4-10 months after medication initiation
measure: Short Crohn's Disease Activity Index (sCDAI)
timeFrame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
measure: Mayo Clinic Score
timeFrame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
measure: PROMIS Social Satisfaction Score
timeFrame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Other outcomes:
Locations:
city: New York
country: United States
facility: Crohn's & Colitis Foundation
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael Kappelman, MD
role: PRINCIPAL_INVESTIGATOR
References: