Corrona Inflammatory Bowel Disease (IBD) Registry

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03162549
Study type	Observational [Patient Registry]
Source	CorEvitas
Contact
Status	Enrolling by invitation
Phase
Start date	March 27, 2017
Completion date	December 2100

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04046913` - The ADDapt Diet in Reducing Crohn's Disease Inflammation	N/A
Active, not recruiting	`NCT04989907` - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting	`NCT05316584` - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy	N/A
Active, not recruiting	`NCT04990258` - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed	`NCT06216223` - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients	N/A
Enrolling by invitation	`NCT06015789` - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting	`NCT06065995` - StoMakker Mobile Application	N/A
Recruiting	`NCT03282786` - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease	N/A
Recruiting	`NCT06002074` - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases	N/A
Recruiting	`NCT04960826` - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting	`NCT05413941` - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease	N/A
Completed	`NCT03668249` - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed	`NCT00721812` - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686	Phase 1
Recruiting	`NCT05809999` - IBD Neoplasia Surveillance RCT	N/A
Recruiting	`NCT04138225` - The Ecological Role of Yeasts in the Human Gut
Recruiting	`NCT04991324` - Cholecalciferol Comedication in IBD - the 5C-study	Phase 3
Completed	`NCT03173144` - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting	`NCT05043818` - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting	`NCT03042091` - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery	Early Phase 1
Completed	`NCT02874365` - Intestinal Stem Cells Characterization	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.