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

NCT04852666 | Completed Results

• 2 other identifiers: 19-0273PaCR-2017C2-8172-IC
• Study Type: observational
• Target: 465
• Locations: 1 country
• Sites: 2

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.

Conditions

Crohn's Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Number of Participants With Index Medication Persistence

  4-10 months after medication initiation

• Number of Participants Using Corticosteroids at Follow-Up

  4-10 months after medication initiation

• Short Crohn's Disease Activity Index (sCDAI)

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

• Mayo Clinic Score

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

• PROMIS Social Satisfaction Score

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

Study Arms (4)

Crohn's Disease (Vedolizumab)

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

Crohn's Disease (Ustekinumab)

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

Ulcerative Colitis (Vedolizumab)

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

Ulcerative Colitis (Tofacitinib)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population: participants in IBD Partners or SPARC cohort.

You may qualify if:

• 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.

You may not qualify if:

• less than 18 years of age

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Crohn's and Colitis Foundation: collaborator

Study Sites (2)

Crohn's & Colitis Foundation

New York, New York, 10017, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599-7555, United States

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Results Point of Contact

• Title: Michael Kappelman, MD, MPH
• Organization: University of North Carolina at Chapel Hill

michael_kappelman@med.unc.edu

919-843-5908

Study Officials

• Michael Kappelman, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: July 25, 2019
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: June 14, 2024
• Results First Posted: June 14, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)