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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 : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Tracking Information
First Submitted Date July 28, 2017
First Posted Date August 16, 2017
Last Update Posted Date February 4, 2019
Actual Study Start Date July 24, 2017
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 11, 2017)
  • Natural history of Inflammatory Bowel Disease: Characteristics of IBD [ Time Frame: Up to 5 years ]
  • Natural history of Inflammatory Bowel Disease: Participant demographics [ Time Frame: Up to 5 years ]
  • Natural history of Inflammatory Bowel Disease: Treatment use [ Time Frame: Up to 5 years ]
  • Natural history of Inflammatory Bowel Disease: Treatment response [ Time Frame: Up to 5 years ]
  • Natural history of Inflammatory Bowel Disease: Disease progression [ Time Frame: Up to 5 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03251118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 11, 2017)
  • Endoscopic measures of mucosal healing [ Time Frame: Up to 5 years ]
  • Adverse event frequency and severity [ Time Frame: Every 3 months for 5 years ]
  • Timepoint of clinical response [ Time Frame: Every 3 months for 5 years ]
  • Timepoint of endoscopic response [ Time Frame: Up to 5 years ]
  • Reasons for treatment discontinuation [ Time Frame: Up to 5 years ]
  • Self-reported patient health measures: EQ-5D [ Time Frame: Every 3 months for 5 years ]
  • Self-reported patient health measures: PRO-2 for Crohn's Disease [ Time Frame: Every 3 months for 5 years ]
  • Self-reported patient health measures: PRO-2 for Ulcerative colitis [ Time Frame: Every 3 months for 5 years ]
  • Self-reported patient health measures: 2-question Adherence Measure [ Time Frame: Every 3 months for 5 years ]
  • Self-reported patient health measures: Manitoba IBD Index (MIBDI) [ Time Frame: Every 3 months for 5 years ]
  • Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI) [ Time Frame: Every 3 months for 5 years ]
  • Timepoint of endoscopic remission [ Time Frame: Up to 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Official Title A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
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.
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
Condition
  • Inflammatory Bowel Diseases
  • Crohn's Disease
  • Ulcerative Colitis
  • Indeterminate Colitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 11, 2017)
15000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laura Dalfonso 9842340268 ldalfonso@targetpharmasolutions.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03251118
Other Study ID Numbers TARGET-IBD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Target PharmaSolutions, Inc.
Study Sponsor Target PharmaSolutions, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Target PharmaSolutions, Inc.
Verification Date February 2019