Status:
COMPLETED
SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
Lead Sponsor:
UCB BIOSCIENCES, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 an...
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 Criteria
Inclusion
- 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
- See inclusion criteria
Key Trial Info
Start Date :
January 30 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 21 2020
Estimated Enrollment :
3072 Patients enrolled
Trial Details
Trial ID
NCT00844285
Start Date
January 30 2009
End Date
August 21 2020
Last Update
May 6 2023
Active Locations (197)
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1
C87075 931
Birmingham, Alabama, United States, 35209
2
C87075 198
Birmingham, Alabama, United States, 35233
3
C87075 286
Huntsville, Alabama, United States, 35802
4
C87075 032
Montgomery, Alabama, United States, 36116