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

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

465 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-25

Study Completion Date

2022-12-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Crohn's Disease Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Crohn's Disease (Vedolizumab)

Participants with Crohn's disease (CD) who reported taking vedolizumab.

No interventions assigned to this group

Crohn's Disease (Ustekinumab)

Participants with Crohn's disease (CD) who reported taking ustekinumab.

No interventions assigned to this group

Ulcerative Colitis (Vedolizumab)

Participants with Ulcerative colitis (UC) who reported taking vedolizumab.

No interventions assigned to this group

Ulcerative Colitis (Tofacitinib)

Participants with Ulcerative colitis (UC) who reported taking tofacitinib.

No interventions assigned to this group

Eligibility Criteria

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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.