Brief Summary
This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for IBD in a cohort of patients cared for by gastroenterologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.
Brief Title
CorEvitas Inflammatory Bowel Disease (IBD) Registry
Detailed Description
The objective of the CorEvitas Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD. The diseases under study include Crohn's Disease (CD) and Ulcerative Colitis (UC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the prevalence and incidence of comorbidities and adverse events, medication utilization patterns, and patient productivity measures.
The design is a prospective, non-interventional registry for patients with IBD under the care of a certified gastroenterologist. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters using CorEvitas registry questionnaires. These questionnaires collect data on patient demographics, disease duration, medical history (including all prior and current treatments for IBD), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes.
After the enrollment visit, IBD patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals, not to exceed 2 visits in any 12 month period.
Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.
The design is a prospective, non-interventional registry for patients with IBD under the care of a certified gastroenterologist. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters using CorEvitas registry questionnaires. These questionnaires collect data on patient demographics, disease duration, medical history (including all prior and current treatments for IBD), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes.
After the enrollment visit, IBD patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals, not to exceed 2 visits in any 12 month period.
Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
508-408-5435
Central Contact Email
corevitasregistrytrials@corevitas.com
Completion Date
Completion Date Type
Estimated
Conditions
Inflammatory Bowel Diseases
Eligibility Criteria
ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the CorEvitas IBD Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.
Inclusion Criteria:
* At least 18 years of age or older.
* Willing and able to provide written consent for participation in the IBD Registry.
* Willing and able to provide Personally Identifiable Information (PII) which includes the following types of personal information at a minimum: full name, date of birth, sex, and home address zip code.
* Diagnosis of one of the following by a gastroenterologist:
1. Crohn's disease
2. Ulcerative colitis
* Prevalent users or new /incident users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease.
Exclusion Criteria:
• Participating in or planning to participate in a clinical trial (Phase I - III) or a post-marketing study or registry (i.e. phase IV).∆
Inclusion Criteria:
* At least 18 years of age or older.
* Willing and able to provide written consent for participation in the IBD Registry.
* Willing and able to provide Personally Identifiable Information (PII) which includes the following types of personal information at a minimum: full name, date of birth, sex, and home address zip code.
* Diagnosis of one of the following by a gastroenterologist:
1. Crohn's disease
2. Ulcerative colitis
* Prevalent users or new /incident users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease.
Exclusion Criteria:
• Participating in or planning to participate in a clinical trial (Phase I - III) or a post-marketing study or registry (i.e. phase IV).∆
Inclusion Criteria
inclusion criteria and none of the Inclusion Criteria:
* At least 18 years of age or older.
* Willing and able to provide written consent for participation in the IBD Registry.
* Willing and able to provide Personally Identifiable Information (PII) which includes the following types of personal information at a minimum: full name, date of birth, sex, and home address zip code.
* Diagnosis of one of the following by a gastroenterologist:
1. Crohn's disease
2. Ulcerative colitis
* Prevalent users or new /incident users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease.
* At least 18 years of age or older.
* Willing and able to provide written consent for participation in the IBD Registry.
* Willing and able to provide Personally Identifiable Information (PII) which includes the following types of personal information at a minimum: full name, date of birth, sex, and home address zip code.
* Diagnosis of one of the following by a gastroenterologist:
1. Crohn's disease
2. Ulcerative colitis
* Prevalent users or new /incident users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03162549
Org Class
Network
Org Full Name
CorEvitas
Org Study Id
CorEvitas-IBD-600
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
CorEvitas Inflammatory Bowel Disease (IBD) Registry
Primary Outcomes
Outcome Description
The major clinical outcomes include an assessment of the epidemiology of Inflammatory Bowel Disease; to better understand the presentation, natural history, management and outcomes.
Outcome Measure
IBD epidemiology, presentation, natural history, management, and outcomes
Outcome Time Frame
Time Frame: A minimum of 10 years from last patient enrolled
Secondary Outcomes
Outcome Time Frame
[Time Frame: every 6 months for 10 years]
Outcome Measure
Disease burden: Harvey-Bradshaw Index
Outcome Time Frame
[Time Frame: every 6 months for 10 years]
Outcome Measure
Disease burden: Fistula History
Outcome Time Frame
[Time Frame: every 6 months for 10 years]
Outcome Measure
Disease burden: Disease Location and Behavior
Outcome Time Frame
[Time Frame: time frame: at registry enrollment]
Outcome Measure
Percentage of patients with history of comorbidities
Outcome Time Frame
[Time Frame: time frame: every 6 months for 10 years]
Outcome Measure
Physician reported: Pouchitis
Outcome Time Frame
[Time Frame: time frame: every 6 months for 10 years]
Outcome Measure
Physician reported: Simple Clinical Colitis Activity Index (SCCAI)
Outcome Time Frame
[Time Frame: time frame: every 6 months for 10 years]
Outcome Measure
Physician reported: Mayo Severity Index
Outcome Time Frame
[Time Frame: time frame: every 6 months for 10 years]
Outcome Measure
Physician reported: IBD related extraintestinal manifestations
Outcome Time Frame
[Time Frame: time frame: every 6 months for 10 years]
Outcome Measure
Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI)
Outcome Time Frame
[Time Frame: time frame: every 6 months for 10 years]
Outcome Measure
Patient reported: PROMIS
See Also Links
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
Patients are enrolled in the Inflammatory Bowel Disease (IBD) Registry during regularly -scheduled office visits. Selected gastroenterologist are invited to participate as investigators in the Registry.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Thomas Ullman
Investigator Email
tullman@montefiore.org
Investigator Phone
347-671-8211