A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease (TARGET-IBD)

• ClinicalTrials.gov Identifier: NCT03251118
• Recruitment Status: Recruiting
• First Posted: August 16, 2017
• Last Update Posted: August 29, 2019
• Sponsor: Target PharmaSolutions, Inc.
• Information provided by (Responsible Party): Target PharmaSolutions, Inc.

Study Description

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.

Condition or disease
Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis; Indeterminate Colitis

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 15000 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 5 Years
• Official Title: A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
• Actual Study Start Date: July 24, 2017
• Estimated Primary Completion Date: July 2025
• Estimated Study Completion Date: July 2025

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Natural history of Inflammatory Bowel Disease: Characteristics of IBD [ Time Frame: Up to 5 years ]
2. Natural history of Inflammatory Bowel Disease: Participant demographics [ Time Frame: Up to 5 years ]
3. Natural history of Inflammatory Bowel Disease: Treatment use [ Time Frame: Up to 5 years ]
4. Natural history of Inflammatory Bowel Disease: Treatment response [ Time Frame: Up to 5 years ]
5. Natural history of Inflammatory Bowel Disease: Disease progression [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :

1. Endoscopic measures of mucosal healing [ Time Frame: Up to 5 years ]
2. Adverse event frequency and severity [ Time Frame: Every 3 months for 5 years ]
3. Timepoint of clinical response [ Time Frame: Every 3 months for 5 years ]
4. Timepoint of endoscopic response [ Time Frame: Up to 5 years ]
5. Reasons for treatment discontinuation [ Time Frame: Up to 5 years ]
6. Self-reported patient health measures: EQ-5D [ Time Frame: Every 3 months for 5 years ]
7. Self-reported patient health measures: PRO-2 for Crohn's Disease [ Time Frame: Every 3 months for 5 years ]
8. Self-reported patient health measures: PRO-2 for Ulcerative colitis [ Time Frame: Every 3 months for 5 years ]
9. Self-reported patient health measures: 2-question Adherence Measure [ Time Frame: Every 3 months for 5 years ]
10. Self-reported patient health measures: Manitoba IBD Index (MIBDI) [ Time Frame: Every 3 months for 5 years ]
11. Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI) [ Time Frame: Every 3 months for 5 years ]
12. Timepoint of endoscopic remission [ Time Frame: Up to 5 years ]

Biospecimen Retention:   Samples With DNA

Patients enrolled in TARGET-IBD may be invited to participate in the Biorepository Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the participant's unique study ID number and the date the sample was obtained. The link between the participant's study ID number and their name will be available only at the site where the samples were obtained.

Eligibility Criteria

• Ages Eligible for Study: 2 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adults and children (age 2 or older) with a diagnosis of Crohn's disease, Ulcerative colitis, or Indeterminate colitis having been prescribed any IBD treatment outside of a clinical trial

Criteria

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.

Contacts and Locations

Contacts

Contact: Laura Dalfonso; 9842340268; ldalfonso@targetpharmasolutions.com

  Show 35 Study Locations

Sponsors and Collaborators

Target PharmaSolutions, Inc.

More Information

Additional Information:

• Responsible Party: Target PharmaSolutions, Inc.
• ClinicalTrials.gov Identifier: NCT03251118 History of Changes
• Other Study ID Numbers: TARGET-IBD
• First Posted: August 16, 2017
• Last Update Posted: August 29, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Target PharmaSolutions, Inc.:

Crohn's Disease; Ulcerative colitis; Indeterminate colitis; Digestive System Diseases

Additional relevant MeSH terms:

Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Pathologic Processes