N/A
N=3,072
SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00844285 ↗Enrolled (actual)
3,072
Serious AEs
23.0%
Results posted
May 2023
Primary outcome: Primary: Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) — 0.45; 0.65 no. of events per 100 participant-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cimzia (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UCB BIOSCIENCES, Inc.
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) |
0.45; 0.65 | — |
| PRIMARY Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) |
0.35; 0.59; 0.60; 0.56; 0.48; 2.03 | — |
| SECONDARY Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment |
-1.1; -0.7; -1.3; -1.2; -0.8; -1.3 | — |
| SECONDARY Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment |
0.6; 0.2; 0.1; 0.2; -0.1; -0.0 | — |
| SECONDARY Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment |
-0.4; -0.2; -0.3; -0.5; -0.3; -0.3 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment |
-0.0; -0.0; -0.1; -0.2; -0.1; -0.1 | — |
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 and it's objective is to monitor patients for approximately 8 years.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00844285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.