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.
Brief Title
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Central Contacts
Central Contact Role
Contact
Central Contact Phone
9842340268
Central Contact Email
ldalfonso@targetpharmasolutions.com
Completion Date
Completion Date Type
Estimated
Conditions
Inflammatory Bowel Diseases
Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
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.
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.
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
Crohn's Disease
Ulcerative colitis
Indeterminate colitis
Digestive System Diseases
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
2 Years
NCT Id
NCT03251118
Org Class
Industry
Org Full Name
Target PharmaSolutions, Inc.
Org Study Id
TARGET-IBD
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease
Primary Outcomes
Outcome Measure
Natural history of Inflammatory Bowel Disease: Characteristics of IBD
Outcome Time Frame
Up to 5 years
Outcome Measure
Natural history of Inflammatory Bowel Disease: Participant demographics
Outcome Time Frame
Up to 5 years
Outcome Measure
Natural history of Inflammatory Bowel Disease: Treatment use
Outcome Time Frame
Up to 5 years
Outcome Measure
Natural history of Inflammatory Bowel Disease: Treatment response
Outcome Time Frame
Up to 5 years
Outcome Measure
Natural history of Inflammatory Bowel Disease: Disease progression
Outcome Time Frame
Up to 5 years
Secondary Outcomes
Outcome Time Frame
Up to 5 years
Outcome Measure
Endoscopic measures of mucosal healing
Outcome Time Frame
Every 3 months for 5 years
Outcome Measure
Adverse event frequency and severity
Outcome Time Frame
Every 3 months for 5 years
Outcome Measure
Timepoint of clinical response
Outcome Time Frame
Up to 5 years
Outcome Measure
Timepoint of endoscopic response
Outcome Time Frame
Up to 5 years
Outcome Measure
Reasons for treatment discontinuation
Outcome Time Frame
Every 3 months for 5 years
Outcome Measure
Self-reported patient health measures: EQ-5D
Outcome Time Frame
Every 3 months for 5 years
Outcome Measure
Self-reported patient health measures: PRO-2 for Crohn's Disease
Outcome Time Frame
Every 3 months for 5 years
Outcome Measure
Self-reported patient health measures: PRO-2 for Ulcerative colitis
Outcome Time Frame
Every 3 months for 5 years
Outcome Measure
Self-reported patient health measures: 2-question Adherence Measure
Outcome Time Frame
Every 3 months for 5 years
Outcome Measure
Self-reported patient health measures: Manitoba IBD Index (MIBDI)
Outcome Time Frame
Every 3 months for 5 years
Outcome Measure
Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI)
Outcome Time Frame
Up to 5 years
Outcome Measure
Timepoint of endoscopic remission
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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
Std Ages
Child
Adult
Older Adult
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Gitit Tomer
Investigator Email
gitomer@montefiore.org
Investigator Phone
718-741-2332