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

Purpose

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 4000 patients and it's objective is to monitor patients for approximately 10 years.

Condition	Intervention
Crohn's Disease	Drug: Cimzia

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Percentage of subjects with at least one Serious Adverse Event (SAE) during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
An SAE is any untoward medical occurrence which results in death, is life-threatening, requires or prolongs hospitalization, results in persistent/permanent disability/incapacitation, results in a congenital anomaly/birth defect, or any important medical event.
Percentage of subjects with at least one non-serious Adverse Event (AE) of interest during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
AEs of interest include Autoimmune disorders, Demyelinating disorders, Serious infections or opportunistic infections, Lymphoma and other malignancies, and Hypersensitivity reactions.

Secondary Outcome Measures:

Incidence rates per 100 patient-years of Serious Adverse Events for subjects in this study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
An SAE is any untoward medical occurrence which results in death, is life-threatening, requires or prolongs hospitalization, results in persistent/permanent disability/incapacitation, results in a congenital anomaly/birth defect, or any important medical event.
Incidence rates per 100 patient-years of Adverse Events (AEs) of interest for subjects in this study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
AEs of interest include Autoimmune disorders, Demyelinating disorders, Serious infections or opportunistic infections, Lymphoma and other malignancies, and Hypersensitivity reactions.
Mean number of doses received by subjects during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
Harvey Bradshaw Index (HBI) total score at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
HBI scores consist of clinical parameters for general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (1 per item). Lower scores indicated better well-being.
Harvey Bradshaw Index (HBI) total score at Last/Withdrawal visit (up to 10 years) [ Time Frame: Last/Withdrawal visit (up to 10 years) ] [ Designated as safety issue: No ]
HBI scores consist of clinical parameters for general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (1 per item). Lower scores indicated better well-being.
Physician's assessment of disease at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Physician's assessment of disease at Last/Withdrawal visit (up to 10 years) [ Time Frame: Last/Withdrawal visit (up to 10 years) ] [ Designated as safety issue: No ]
Patient's assessment of disease at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Patient's assessment of disease at Last/Withdrawal visit (up to 10 years) [ Time Frame: Last/Withdrawal visit (up to 10 years) ] [ Designated as safety issue: No ]

Estimated Enrollment:	4000
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2023
Estimated Primary Completion Date:	April 2022 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cimzia Cohort: Patient about to receive treatment with Cimzia® as part of pre-existing management plan for Crohn's disease or has already been receiving treatment with Cimzia® for < 6 months	Drug: Cimzia The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.
Comparison cohort Patient must be about to receive treatment with any other medication as part of a pre-existing management plan for Crohn's disease or has already been receiving treatment (previous Cimzia® treatment is prohibited).

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients of selected gastroenterologists and internal medicine physicians from both community-based and academic practice settings (75% and 25% respectively) Each physician should be able to recruit a minimum of 5 patients prescribed Cimzia® and/or 5 patients prescribed other treatments.

Recruitment into both cohorts will be monitored and controlled as needed in order to ensure balanced enrollment over time. In order to ensure reasonable balance between both cohorts, retrospective frequency matching will be applied for disease severity (mild/moderate/severe), age categories and gender.

Criteria

Inclusion Criteria:

Patient must have medically documented Crohn's disease
The decision to prescribe Cimzia or other medications has been made by the physician independent of inclusion in this study
For the Cimzia cohort: Patient must be about to receive treatment with Cimzia® for Crohn's disease or has already been receiving treatment with Cimzia® for ≤6 months.
For the comparison cohort: Patient must be about to receive treatment with any other medication (other than Cimzia) for Crohn's disease or has already been receiving treatment or the patient has one of the following criteria: -currently receiving or history of anti-TNF treatment -currently receiving or history of immunosuppressant therapy within 6 months -currently receiving or history of systemic steroid therapy within 6 months

Exclusion Criteria:

See inclusion criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844285

Show 191 Study Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00844285 History of Changes
Other Study ID Numbers:	C87075
Study First Received:	February 13, 2009
Last Updated:	April 22, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Certolizumab Pegol, Cimzia ®
Crohn's Disease

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 19, 2013