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Trial record 1 of 1 for:    03162549
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Corrona Inflammatory Bowel Disease (IBD) Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03162549
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Corrona, LLC.

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.

Condition or disease
Inflammatory Bowel Diseases

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), 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
Inflammatory Bowel Disease
Pts presenting to enrolling sites across the US are invited to enroll if eligible



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Disease burden: Harvey-Bradshaw Index [ Time Frame: [Time Frame: every 6 months for 10 years] ]
  2. Disease burden: Fistula History [ Time Frame: [Time Frame: every 6 months for 10 years] ]
  3. Disease burden: Disease Location and Behavior [ Time Frame: [Time Frame: every 6 months for 10 years] ]
  4. Percentage of patients with history of comorbidities [ Time Frame: [Time Frame: time frame: at registry enrollment] ]
  5. Physician reported: Pouchitis [ Time Frame: [Time Frame: time frame: every 6 months for 10 years] ]
  6. Physician reported: Simple Clinical Colitis Activity Index (SCCAI) [ Time Frame: [Time Frame: time frame: every 6 months for 10 years] ]
  7. Physician reported: Mayo Severity Index [ Time Frame: [Time Frame: time frame: every 6 months for 10 years] ]
  8. Physician reported: IBD related extraintestinal manifestations [ Time Frame: [Time Frame: time frame: every 6 months for 10 years] ]
  9. Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI) [ Time Frame: [Time Frame: time frame: every 6 months for 10 years] ]
  10. Patient reported: PROMIS [ Time Frame: [Time Frame: time frame: every 6 months for 10 years] ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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:

    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).∆

Eligible Medications Grouped by Drug Class & Diagnosis

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)

∆ 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).


Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Corrona, LLC
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Corrona, LLC.
Investigators
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Study Director: Jeffrey Greenberg, MD Corrona, LLC.
Additional Information:
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Responsible Party: Corrona, LLC.
ClinicalTrials.gov Identifier: NCT03162549    
Other Study ID Numbers: Corrona-IBD-600
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis