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

• Percentage of subjects with at least one Serious Adverse Event (SAE) during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
  An SAE is any untoward medical occurrence which results in death, is life-threatening, requires or prolongs hospitalization, results in persistent/permanent disability/incapacitation, results in a congenital anomaly/birth defect, or any important medical event.
• Percentage of subjects with at least one non-serious Adverse Event (AE) of interest during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
  AEs of interest include Autoimmune disorders, Demyelinating disorders, Serious infections or opportunistic infections, Lymphoma and other malignancies, and Hypersensitivity reactions.

• Incidence rates per 100 patient-years of Serious Adverse Events for subjects in this study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
  An SAE is any untoward medical occurrence which results in death, is life-threatening, requires or prolongs hospitalization, results in persistent/permanent disability/incapacitation, results in a congenital anomaly/birth defect, or any important medical event.
• Incidence rates per 100 patient-years of Adverse Events (AEs) of interest for subjects in this study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
  AEs of interest include Autoimmune disorders, Demyelinating disorders, Serious infections or opportunistic infections, Lymphoma and other malignancies, and Hypersensitivity reactions.
• Mean number of doses received by subjects during the study (approximately 10 years) [ Time Frame: Approximately 10 years ] [ Designated as safety issue: No ]
• Harvey Bradshaw Index (HBI) total score at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  HBI scores consist of clinical parameters for general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (1 per item). Lower scores indicated better well-being.
• Harvey Bradshaw Index (HBI) total score at Last/Withdrawal visit (up to 10 years) [ Time Frame: Last/Withdrawal visit (up to 10 years) ] [ Designated as safety issue: No ]
  HBI scores consist of clinical parameters for general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (1 per item). Lower scores indicated better well-being.
• Physician's assessment of disease at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
• Physician's assessment of disease at Last/Withdrawal visit (up to 10 years) [ Time Frame: Last/Withdrawal visit (up to 10 years) ] [ Designated as safety issue: No ]
• Patient's assessment of disease at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
• Patient's assessment of disease at Last/Withdrawal visit (up to 10 years) [ Time Frame: Last/Withdrawal visit (up to 10 years) ] [ Designated as safety issue: No ]

• Incidence rates and recurrence for SAEs and specific events of interest [ Time Frame: Every 6 months for 10 years ] [ Designated as safety issue: Yes ]
• Exposure to Cimzia® or other medications [ Time Frame: Every 3 - 6 months for 10 years ] [ Designated as safety issue: Yes ]
• HBI rating scale [ Time Frame: Every 6 months for 10 years ] [ Designated as safety issue: Yes ]
• Physician's assessment of disease [ Time Frame: Every 3 - 6 months for 10 years ] [ Designated as safety issue: Yes ]
• Patient's disease assessment [ Time Frame: Every 3 - 6 months for 10 years ] [ Designated as safety issue: Yes ]
• Reason for discontinuation of Cimzia® or other medications [ Time Frame: Every 6 months for 10 years ] [ Designated as safety issue: Yes ]

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 4000 patients and it's objective is to monitor patients for approximately 10 years.

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.

Patients of selected gastroenterologists and internal medicine physicians from both community-based and academic practice settings (75% and 25% respectively) Each physician should be able to recruit a minimum of 5 patients prescribed Cimzia® and/or 5 patients prescribed other treatments.

Recruitment into both cohorts will be monitored and controlled as needed in order to ensure balanced enrollment over time. In order to ensure reasonable balance between both cohorts, retrospective frequency matching will be applied for disease severity (mild/moderate/severe), age categories and gender.

• Cimzia Cohort:
  Patient about to receive treatment with Cimzia® as part of pre-existing management plan for Crohn's disease or has already been receiving treatment with Cimzia® for < 6 months
  Intervention: Drug: Cimzia
• Comparison cohort
  Patient must be about to receive treatment with any other medication as part of a pre-existing management plan for Crohn's disease or has already been receiving treatment (previous Cimzia® treatment is prohibited).

Inclusion Criteria:

• Patient must have medically documented Crohn's disease
• The decision to prescribe Cimzia or other medications has been made by the physician independent of inclusion in this study
• For the Cimzia cohort: Patient must be about to receive treatment with Cimzia® for Crohn's disease or has already been receiving treatment with Cimzia® for ≤6 months.
• For the comparison cohort: Patient must be about to receive treatment with any other medication (other than Cimzia) for Crohn's disease or has already been receiving treatment or the patient has one of the following criteria: -currently receiving or history of anti-TNF treatment -currently receiving or history of immunosuppressant therapy within 6 months -currently receiving or history of systemic steroid therapy within 6 months

Exclusion Criteria:

• See inclusion criteria