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

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ClinicalTrials.gov Identifier: NCT03251118
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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

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





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.


Information from the National Library of Medicine

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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.

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
Contact: Chuck Moser 984-234-0268 ext 213 cmoser@targetpharmasolutions.com

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Sponsors and Collaborators
Target PharmaSolutions, Inc.

Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT03251118     History of Changes
Other Study ID Numbers: TARGET-IBD
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
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:
Inflammatory Bowel Diseases
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes