SECUREA Non-Interventional Long-term Post-Marketing Registry of Patients Treated withCertolizumab Pegol (Cimzia®) for Crohn's Disease

Principal Investigator: Kathleen Boynton
Keywords: Cimzia , Crohn's Disease , Digestive System Diseases , Gastrointestinal Diseases , Inflammatory Bowel Disease Department: Gastroenterology
IRB Number: 00035974 Co Investigator:  
Specialty: Gastroenterology
Sub Specialties: Inflammatory Bowel Disease/Crohn's/Ulcerative Colitis
Recruitment Status: Recruiting

Contact Information

Hannah  Kinnebrew
hannah.kinnebrew@hsc.utah.edu
801-581-3693

Brief Summary

The objective of this registry is to measure the safety outcomes among Cimzia patients
compared to those that occur while on a different CD treatment regimen.
All SAEs and AEs of interest will be collected and summarized (see Section 10). The AEs of
interest are: selected autoimmune disorders and demyelinating disorders, serious infections
including opportunistic infections, hypersensitivity reactions, lymphoma and other
malignancies. In addition, UCB plans to evaluate aplastic anemia and serious cardiac events
(specifically, CHF). All these events represent serious risks known to the class of tumor
necrosis factor (TNF) blocking agents. During the development program for CD and
rheumatoid arthritis consisting of over 6,000 subjects, reported events were consistent with
the class.

 

Inclusion Criteria

Patients who meet all of the following criteria will be eligible for inclusion into the SECURE
Registry:
 Patient (or his/her legally acceptable representative) is able to provide written informed
consent to permit collection of data.
 Patient must be 18 years of age or older.
 Patient must have medically documented CD.
 The decision to prescribe Cimzia or other medications has been made by the investigator
independently of the decision to include the patient in the study.
 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.
Cimzia-treated patients
For a patient to qualify as being treated with Cimzia, they must meet one of the following
criteria:
 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. Patients must also
receive a Cimzia dose within 2 months following enrollment into the registry.
Comparator patients
Patients enrolled in the comparator group are eligible to participate in the registry if one of
the following criteria is fulfilled:
 Patient is switching CD treatments 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.
Patients must fit into at least ONE of the following 3 criteria:
 Patient is currently receiving for CD anti-TNF treatment (or other approved biologics) for
≤12 months. Patient must receive anti-TNF treatment (or other biologics) 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 the registry.

Exclusion Criteria

None