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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03251118
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : November 23, 2020
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251118


Contacts
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Contact: Laura Dalfonso 9842340268 ldalfonso@targetpharmasolutions.com

Locations
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Sponsors and Collaborators
Target PharmaSolutions, Inc.
More Information
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Additional Information:

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Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT03251118    
Other Study ID Numbers: TARGET-IBD
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: November 23, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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