SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry



Status:Active, not recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:January 2009
End Date:August 2025

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A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease

The purpose of this study is to monitor safety outcomes of patients who have taken Cimzia® as
compared to a non- Cimzia® control population. The SECURE Registry's target enrollment is
3045 patients and it's objective is to monitor patients for approximately 8 years.

Physicians are expected to manage patients as they would under normal practice conditions;
patients will receive and use their medications according to their normal course of medical
treatment.

Inclusion Criteria:

- Patient must have medically documented Crohn's disease (CD)

- The decision to prescribe Cimzia or other medications has been made by the physician
independent of inclusion in this study

- Patient (or his/her legally acceptable representative) is able to provide written
informed consent to permit collection of data

- Patients participating in randomized, blinded clinical trials for CD or other
conditions are not eligible for inclusion into the SECURE registry. Involvement in
other registries, where patients follow routine clinical practice, is permitted,
however

- For the Cimzia cohort: Patient is receiving treatment with Cimzia for the first time.
Patient must receive Cimzia treatment within 2 months of enrollment into the registry

- Patient is currently receiving treatment with Cimzia for <=12 months. Patient must
also receive a Cimzia dose within 2 months following enrollment into the registry

- For the comparison cohort: Patient is switching CD treatment or beginning CD treatment
for the first time. Previous Cimzia treatment is prohibited in the comparator group.
Patient must receive new CD treatment within 2 months of enrollment into the registry.
Patient is currently receiving anti-TNF treatment for <=12 months. Patient must
receive anti-TNF treatment within 2 months following enrollment into the registry.
Patient is currently receiving immunosuppressant therapy for <=12 months. Patient must
receive immunosuppressant therapy within 2 months following enrollment into the
registry. Patient is currently receiving systemic steroid therapy for <=12 months.
Patient must receive systemic steroid therapy within 2 months following enrollment
into registry.

Exclusion Criteria:

- See inclusion criteria
We found this trial at
198
sites
Allentown, Pennsylvania
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Altamonte Springs, Florida
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Atlanta, Georgia
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Austin, Texas
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Baltimore, Maryland
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Beverly Hills, California
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Bismarck, North Dakota
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Boca Raton, Florida
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Boston, Massachusetts
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Chapel Hill, North Carolina
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Cumming, Georgia
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Decatur, Georgia
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Egg Harbor Township, New Jersey
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Encinitas, California
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Evanston, Illinois
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Flushing, New York
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Fort Sam Houston, Texas
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Fountain Valley, California
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Great Neck, New York
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Green Bay, Wisconsin
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Hermitage, Pennsylvania
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Hoffman Estates, Illinois
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Hollywood, Florida
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Houston, Texas
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Houston, Texas
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Huntsville, Alabama
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Jackson, Tennessee
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Jericho, New York
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Johns Creek, Georgia
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Kalamazoo, Michigan
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Kinston, North Carolina
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La Jolla, California
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Lake Success, New York
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