A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

Recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis

• Registration Number: NCT03251118
• Lead Sponsor: Target PharmaSolutions, Inc.

Brief Summary

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-24
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-17
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

1. Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any IBD treatment (initial or subsequent) outside of a clinical trial.
2. Have plans for future visits at the site for continued management of IBD.

Exclusion Criteria

1. Inability to provide written informed consent/assent.
2. Being enrolled in any interventional study or trial for IBD treatment. Note: Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries).
3. Prior total abdominal colectomy for UC or IBDU.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Natural history of Inflammatory Bowel Disease: Treatment response	Up to 5 years
Natural history of Inflammatory Bowel Disease: Participant demographics	Up to 5 years
Natural history of Inflammatory Bowel Disease: Treatment use	Up to 5 years
Natural history of Inflammatory Bowel Disease: Characteristics of IBD	Up to 5 years
Natural history of Inflammatory Bowel Disease: Disease progression	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Self-reported patient health measures: EQ-5D	Every 3 months for 5 years
Self-reported patient health measures: PRO-2 for Crohn's Disease	Every 3 months for 5 years
Reasons for treatment discontinuation	Up to 5 years
Self-reported patient health measures: PRO-2 for Ulcerative colitis	Every 3 months for 5 years
Self-reported patient health measures: Manitoba IBD Index (MIBDI)	Every 3 months for 5 years
Timepoint of endoscopic response	Up to 5 years
Self-reported patient health measures: 2-question Adherence Measure	Every 3 months for 5 years
Timepoint of endoscopic remission	Up to 5 years
Endoscopic measures of mucosal healing	Up to 5 years
Adverse event frequency and severity	Every 3 months for 5 years
Timepoint of clinical response	Every 3 months for 5 years
Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)	Every 3 months for 5 years

Trial Locations

Locations (37)

Om Research; 🇺🇸 Lancaster, California, United States

FACEY Medical Foundation; 🇺🇸 Mission Hills, California, United States

University of California - Davis; 🇺🇸 Sacramento, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Gastro Florida; 🇺🇸 Clearwater, Florida, United States

University of Florida Health Jacksonville-Gastroenterology; 🇺🇸 Jacksonville, Florida, United States

Advanced Gastroenterology Associates, LLC; 🇺🇸 Palm Harbor, Florida, United States

Atlanta Gastro; 🇺🇸 Atlanta, Georgia, United States

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

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