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

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00844285

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:

The primary endpoint is to track safety outcomes of patients who have taken Cimzia® [ Time Frame: Every 3 - 6 months for 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence rates and recurrence for SAEs and specific events of interest [ Time Frame: Every 6 months for 10 years ] [ Designated as safety issue: No ]
Exposure to Cimzia® or other medications [ Time Frame: Every 3 - 6 months for 10 years ] [ Designated as safety issue: No ]
HBI rating scale [ Time Frame: Every 6 months for 10 years ] [ Designated as safety issue: No ]
Physician's assessment of disease [ Time Frame: Every 3 - 6 months for 10 years ] [ Designated as safety issue: No ]
Patient's disease assessment [ Time Frame: Every 3 - 6 months for 10 years ] [ Designated as safety issue: No ]
Reason for discontinuation of Cimzia® or other medications [ Time Frame: Every 6 months for 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 2023 (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

USA Gastroenterologists and internal medicine physicians from both community-based and academic practice settings

Criteria

Inclusion Criteria:

USA Patients must have medically documented Crohn's disease > 3 months prior to study entry
see cohort requirements

Exclusion Criteria:

See cohort requirements

Contacts and Locations

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

Show 186 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 19, 2012
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 23, 2012