Crohn's Disease, Indeterminate Colitis, Inflammatory Bowel Diseases, Ulcerative Colitis
Conditions
Keywords
Crohn's Disease, Ulcerative colitis, Indeterminate colitis, Digestive System Diseases
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.
Interventions
None listed
Sponsors
Target PharmaSolutions, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Natural history of Inflammatory Bowel Disease: Disease progression | Up to 5 years |
| Natural history of Inflammatory Bowel Disease: Characteristics of IBD | Up to 5 years |
| Natural history of Inflammatory Bowel Disease: Participant demographics | Up to 5 years |
| Natural history of Inflammatory Bowel Disease: Treatment use | Up to 5 years |
| Natural history of Inflammatory Bowel Disease: Treatment response | Up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint of clinical response | Every 3 months for 5 years |
| Timepoint of endoscopic response | Up to 5 years |
| Reasons for treatment discontinuation | Up to 5 years |
| Self-reported patient health measures: EQ-5D | Every 3 months for 5 years |
| Self-reported patient health measures: PRO-2 for Crohn's Disease | Every 3 months for 5 years |
| Self-reported patient health measures: PRO-2 for Ulcerative colitis | Every 3 months for 5 years |
| Self-reported patient health measures: Manitoba IBD Index (MIBDI) | Every 3 months for 5 years |
| Self-reported patient health measures: 2-question Adherence Measure | Every 3 months for 5 years |
| Self-reported patient health measures: Pediatric Ulcerative colitis Activity Index (PUCAI) | Every 3 months for 5 years |
| Timepoint of endoscopic remission | Up to 5 years |
| Endoscopic measures of mucosal healing | Up to 5 years |
| Adverse event frequency and severity | Every 3 months for 5 years |
Countries
United States
Outcome results
None listed