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

University of North Carolina (UNC)

Status

Completed

Conditions

Ulcerative Colitis

Crohn's Disease

Study type

Observational

Funder types

Other

Identifiers

NCT04852666

19-0273

PaCR-2017C2-8172-IC (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

465 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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