- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03162549
Corrona Inflammatory Bowel Disease (IBD) Registry
Study Overview
Status
Conditions
Detailed Description
The objective of the Corrona 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 Corrona 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 Corrona related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Massachusetts
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Waltham, Massachusetts, United States, 02451
- Corrona, LLC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the Corrona 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:
- Crohn's disease
- 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).∆
Eligible Medications Grouped by Drug Class
ANTI-TNF AGENTS AND BIOSIMILARS - Adalimumab (HUMIRA), Adalimumab-atto (AMJEVITA), Certolizumab pegol (CIMZIA), Golimumab (SIMPONI), Infliximab (REMICADE), Infliximab-dyyb (INFLECTRA)
INTEGRIN RECEPTOR ANTAGONISTS - Natalizumab (TYSABRI), Vedolizumab (ENTYVIO)
INTERLEUKIN ANTAGONIST (IL-12 AND IL-23), Ustekinumab (STELARA),
JAK INHIBITOR - Tofacitinib (XELJANZ)
SPHINGSOSINE-1-PHOSPHATE RECEPTOR (S1PR) - Ozanimod (ZEPOSIA)
∆ Once clinical trial participation has ended, a patient is permitted to enroll in the registry if they satisfy the eligibility requirements.
∗ These criteria are subject to change with the needs of the registry at the sole discretion of the Sponsor (Corrona).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Inflammatory Bowel Disease
Pts presenting to enrolling sites across the US are invited to enroll if eligible
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IBD epidemiology, presentation, natural history, management, and outcomes
Time Frame: Time Frame: A minimum of 10 years from last patient enrolled
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The major clinical outcomes include an assessment of the epidemiology of Inflammatory Bowel Disease; to better understand the presentation, natural history, management and outcomes.
|
Time Frame: A minimum of 10 years from last patient enrolled
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease burden: Harvey-Bradshaw Index
Time Frame: [Time Frame: every 6 months for 10 years]
|
[Time Frame: every 6 months for 10 years]
|
Disease burden: Fistula History
Time Frame: [Time Frame: every 6 months for 10 years]
|
[Time Frame: every 6 months for 10 years]
|
Disease burden: Disease Location and Behavior
Time Frame: [Time Frame: every 6 months for 10 years]
|
[Time Frame: every 6 months for 10 years]
|
Percentage of patients with history of comorbidities
Time Frame: [Time Frame: time frame: at registry enrollment]
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[Time Frame: time frame: at registry enrollment]
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Physician reported: Pouchitis
Time Frame: [Time Frame: time frame: every 6 months for 10 years]
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[Time Frame: time frame: every 6 months for 10 years]
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Physician reported: Simple Clinical Colitis Activity Index (SCCAI)
Time Frame: [Time Frame: time frame: every 6 months for 10 years]
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[Time Frame: time frame: every 6 months for 10 years]
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Physician reported: Mayo Severity Index
Time Frame: [Time Frame: time frame: every 6 months for 10 years]
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[Time Frame: time frame: every 6 months for 10 years]
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Physician reported: IBD related extraintestinal manifestations
Time Frame: [Time Frame: time frame: every 6 months for 10 years]
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[Time Frame: time frame: every 6 months for 10 years]
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Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI)
Time Frame: [Time Frame: time frame: every 6 months for 10 years]
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[Time Frame: time frame: every 6 months for 10 years]
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Patient reported: PROMIS
Time Frame: [Time Frame: time frame: every 6 months for 10 years]
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[Time Frame: time frame: every 6 months for 10 years]
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jeffrey Greenberg, MD, CorEvitas
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Corrona-IBD-600
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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