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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00844285
First received: February 13, 2009
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Crohn's Disease
Drug: Cimzia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Incidence rate of Adverse Events (AEs) 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, hypersensitivity reactions and other events (congestive heart failure, aplastic anemia serious bleeding events and serious skin reactions).

    Incidence rate is defined as the number of patients experiencing the event of interest divided by the number person-years without an event (time up to the event for patients experiencing an event, and the full study time for those without an event of interest).


  • Recurrence of Adverse Events (AEs) 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, hypersensitivity reactions and other events (congestive heart failure, aplastic anemia serious bleeding events and serious skin reactions).

    Recurrence rate is defined as the number of patients experiencing a recurrence of the event of interest divided by the number person-years without a recurrence (time up to the recurrence event for patients experiencing an recurrence, and the full study time for those without a recurrence).


  • Time to 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, hypersensitivity reactions and other events (congestive heart failure, aplastic anemia serious bleeding events and serious skin reactions).


Secondary Outcome Measures:
  • Change from Baseline in Harvey Bradshaw Index (HBI) total score yearly (up to 10 years) [ Time Frame: Baseline, year 1 up to year 10 ] [ 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.

  • Change from Baseline in Physician's assessment of disease yearly (up to 10 years) [ Time Frame: Baseline, year 1 up to year 10 ] [ Designated as safety issue: No ]
  • Change from Baseline in Patient's assessment of disease yearly (up to 10 years) [ Time Frame: Baseline, year 1 up to year 10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: January 2009
Estimated Study Completion Date: January 2026
Estimated Primary Completion Date: January 2026 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cimzia Cohort:
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
The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.
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).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844285

  Show 189 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00844285     History of Changes
Other Study ID Numbers: C87075
Study First Received: February 13, 2009
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Certolizumab Pegol, Cimzia ®
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Certolizumab pegol
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014