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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Cimzia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cimzia Cohort:<br>Patients 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 ≤12 months. Patients must also receive a Cimzia dose within 2 months following enrollment. | Drug: Cimzia<br>* The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.<br>|
| Comparison cohort<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events of Interest Per 100 Participants-Years By Actual Treatment (Malignancy Rules) | Incidence rate is defined as the number of participants experiencing the event of interest divided by the number person-years without an event (time up to the event for participants experiencing an event, and the full study time for those without). Adverse events of interest included malignant or unspecified tumor, serious infections, opportunistic infections, serious cardiovascular events, congestive heart failure, demyelinating-like disorders, aplastic anemia, pancytopenia, thrombocytopenia, neutropenia, leucopenia, serious bleeding events, lupus and lupus-like illness, serious skin reactions, hepatic events, hypersensitivity reactions and anaphylactic reactions, malignant lymphomas, non-melanoma skin cancer, autoimmune disorders. Treatment groups are based upon actual treatment conservatively assigning participant time and events to CZP even after stopping CZP. Data for malignant or unspecified tumor as per malignancy rules has been reported in this outcome measure. | Baseline up to 10 years | 
| Incidence of Adverse Events of Interest Per 100 Participant-Years By Actual Treatment (Acute Event Rules) | Incidence rate is defined as the number of participants experiencing the event of interest divided by the number person-years without an event (time up to the event for participants experiencing an event, and the full study time for those without an event of interest). Adverse events of interest (AEoI) included malignant or unspecified tumor, serious infections, opportunistic infections, serious cardiovascular events, congestive heart failure, demyelinating-like disorders, aplastic anemia, pancytopenia, thrombocytopenia, neutropenia, leucopenia, serious bleeding events, lupus and lupus-like illness, serious skin reactions, hepatic events, hypersensitivity reactions and anaphylactic reactions, malignant lymphomas, non-melanoma skin cancer, autoimmune disorders. Data for AEoIs as per acute event rules has been reported in this outcome measure where the AEoI is assigned to the treatment the participant is on at the time of the event. | Baseline up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment | HBI measured 5 parameters: the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), presence of an abdominal mass on physical exam (0= none to 3= definite and tender), and whether there are any complications [1 per item: joint pain (arthralgia), eye inflammation (uveitis), red nodules on skin (erythema nodosum), canker sores (aphthous ulcers), skin wound/ulcers (pyoderma gangrenosum), tear in skin of anal area (anal fissure), fluid or pus drainage from anal area (new fistula), and abscess]. The total HBI score was sum of all the 5 individual parameters, where minimum score was 0 and there was no pre-specified maximum score as it was dependent on the number of liquids stools. Higher HBI scores indicated greater disease activity. A negative change indicated less disease activity. | 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 | HBI response determined based on patient reported HBI total scores was defined as a drop of at least 3 points from baseline HBI total score. Patient reported HBI was composed of 4 parameters: the general well-being (0= very well to 4= terrible), abdominal pain (0= none to 3= severe), number of liquid stools per day (0 to no maximum score), and whether there are any complications [1 per item: joint pain (arthralgia), eye inflammation (uveitis), red nodules on skin (erythema nodosum), canker sores (aphthous ulcers), skin wound/ulcers (pyoderma gangrenosum), tear in skin of anal area (anal fissure), fluid or pus drainage from anal area (new fistula), and abscess]. The total HBI score was sum of all the 4 individual parameters, where minimum score was 0 and there was no pre-specified maximum score as it was dependent on the number of liquids stools. Higher HBI scores indicated greater disease activity. A negative change indicated less disease activity. | 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 | Physician assessment of disease severity was measured by the general well-being component of HBI score and had a score range of 0= very well to 4= terrible. Higher scores indicated greater disease activity. A negative change indicated less disease activity. | 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 Assessment of Disease Total Score to Each Post-Baseline Assessment | Patient assessment of disease severity was measured by the general well-being component of HBI score and had a score range of 0= very well to 4= terrible. Higher scores indicated greater disease activity. A negative change indicated less disease activity. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Certolizumab Pegol, Cimzia ®, Crohn's Disease