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

UCB BIOSCIENCES, Inc.3,072 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,072

Conditions

Crohn's Disease

Interventions

CimziaDRUG

The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (197)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline up to 10 years

Secondary Outcomes

Change From Baseline in Physician's Harvey Bradshaw Index (HBI) Total Score to Each Post-Baseline Assessment

Data from ClinicalTrials.gov

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C87075 931

Birmingham, Alabama, United States

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

...and 187 more locations

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.

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