CompletedNot Applicable

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

United States465 participantsStarted 2019-07-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PROMIS Measures of Pain Interference

Timeframe: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

PROMIS Measures of Fatigue

Timeframe: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)

Trial details

NCT IDNCT04852666

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-15

Results submitted2023-03-22

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