An observational study in Inflammatory Bowel Diseases, sponsored by CorEvitas. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by CorEvitas · Observational
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.
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.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 2,287 is above the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →CorEvitas is the lead sponsor of 28 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Diagnosis of one of the following by a gastroenterologist:
Exclusion Criteria:
Pts presenting to enrolling sites across the US are invited to enroll if eligible
IBD epidemiology, presentation, natural history, management, and outcomes
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: Time Frame: A minimum of 10 years from last patient enrolled
Disease burden: Harvey-Bradshaw Index
Time frame: [Time Frame: every 6 months for 10 years]
Disease burden: Fistula History
Time frame: [Time Frame: every 6 months for 10 years]
Disease burden: Disease Location and Behavior
Time frame: [Time Frame: every 6 months for 10 years]
Percentage of patients with history of comorbidities
Time frame: [Time Frame: time frame: at registry enrollment]
Physician reported: Pouchitis
Time frame: [Time Frame: time frame: every 6 months for 10 years]
Physician reported: Simple Clinical Colitis Activity Index (SCCAI)
Time frame: [Time Frame: time frame: every 6 months for 10 years]
Physician reported: Mayo Severity Index
Time frame: [Time Frame: time frame: every 6 months for 10 years]
Physician reported: IBD related extraintestinal manifestations
Time frame: [Time Frame: time frame: every 6 months for 10 years]
Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI)
Time frame: [Time Frame: time frame: every 6 months for 10 years]
Patient reported: PROMIS
Time frame: [Time Frame: time frame: every 6 months for 10 years]
Plan to share: No
Started Mar 2017 (actual). Primary completion is estimated for Dec 2100, 1,005 months after the start.
Of 243 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 132. This study's planned 1,005 months is above that.
Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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