Corrona Inflammatory Bowel Disease (IBD) Registry
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|ClinicalTrials.gov Identifier: NCT03162549|
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2017
Last Update Posted : February 5, 2020
|Condition or disease|
|Inflammatory Bowel Diseases|
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), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). 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 :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||15 Years|
|Official Title:||Corrona Inflammatory Bowel Disease (IBD) Registry|
|Actual Study Start Date :||March 27, 2017|
|Estimated Primary Completion Date :||December 2100|
|Estimated Study Completion Date :||December 2100|
Inflammatory Bowel Disease
Pts presenting to enrolling sites across the US are invited to enroll if eligible
- IBD epidemiology, presentation, natural history, management, and outcomes [ Time Frame: Time Frame: A minimum of 10 years from last patient enrolled ]The major clinical outcomes include an assessment of the epidemiology of Inflammatory Bowel Disease; to better understand the presentation, natural history, management and outcomes.
- 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] ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162549
|United States, Massachusetts|
|Waltham, Massachusetts, United States, 02451|
|Study Director:||Jeffrey Greenberg, MD||Corrona, LLC.|