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

Completed

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00844285

Run by

UCB BIOSCIENCES, Inc.

People needed

3072

Starts

2009-01-30

Expected to finish

2020-08-21

Last updated by the study team

2023-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• See inclusion criteria

Where it is running

• C87075 198 — Birmingham, Alabama, United States
• C87075 286 — Huntsville, Alabama, United States
• C87075 032 — Montgomery, Alabama, United States
• C87075 253 — Scottsdale, Arizona, United States
• C87075 307 — Tucson, Arizona, United States
• C87075 377 — Tucson, Arizona, United States
• C87075 574 — North Little Rock, Arkansas, United States
• C87075 059 — Beverly Hills, California, United States
• C87075 580 — Encino, California, United States
• C87075 021 — Fountain Valley, California, United States
• C87075 261 — La Jolla, California, United States
• C87075 220 — Los Angeles, California, United States
• C87075 728 — Oceanside, California, United States
• C87075 571 — Palm Springs, California, United States
• C87075 485 — San Carlos, California, United States
• C87075 027 — Torrance, California, United States
• C87075 946 — Boulder, Colorado, United States
• C87075 491 — Lonetree, Colorado, United States
• C87075 087 — Hamden, Connecticut, United States
• C87075 077 — Hartford, Connecticut, United States
• C87075 097 — Torrington, Connecticut, United States
• C87075 639 — Altamonte Springs, Florida, United States
• C87075 049 — Boca Raton, Florida, United States
• C87075 871 — Boca Raton, Florida, United States
• C87075 931 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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