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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT00844285
• Date of registration: 13/02/2009
• Prospective Registration: No
• Primary sponsor: UCB BIOSCIENCES, Inc.
• Public title: SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry SECURE
• Scientific title: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease
• Date of first enrolment: January 30, 2009
• Target sample size: 3072
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00844285
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: UCB Cares
• Affiliation: 001 844 599 2273(UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Cimzia

Primary Outcome(s)

Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) [Time Frame: Baseline up to 10 years]

Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) [Time Frame: Baseline up to 10 years]

Secondary Outcome(s)

Change From Baseline in Patient's Assessment of Disease Total Score to Each Post-Baseline Assessment [Time Frame: Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105 and 108, compared to Baseline]

Change From Baseline in Physician's Assessment of Disease Total Score to Each Post-Baseline Assessment [Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline]

Change From Baseline in Patient's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment [Time Frame: Month 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105 and 108, compared to Baseline]

Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment [Time Frame: Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, and 108, compared to Baseline]

Secondary ID(s)

C87075

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/05/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00844285