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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00844285
Recruitment Status : Active, not recruiting
First Posted : February 16, 2009
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date February 13, 2009
First Posted Date February 16, 2009
Last Update Posted Date July 19, 2019
Actual Study Start Date January 2009
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 9, 2017)
  • Incidence rate of Adverse Events (AEs) of interest during the study (approximately 8 years) [ Time Frame: Approximately 8 years ]
    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 8 years) [ Time Frame: Approximately 8 years ]
    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 8 years) [ Time Frame: Approximately 8 years ]
    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).
Original Primary Outcome Measures
 (submitted: February 13, 2009)
The primary endpoint is to track safety outcomes of patients who have taken Cimzia® [ Time Frame: Every 3 - 6 months for 10 years ]
Change History Complete list of historical versions of study NCT00844285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 9, 2017)
  • Change from Baseline in Harvey Bradshaw Index (HBI) total score yearly (up to 8 years) [ Time Frame: Baseline, year 1 up to year 8 ]
    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 8 years) [ Time Frame: Baseline, year 1 up to year 8 ]
  • Change from Baseline in Patient's assessment of disease yearly (up to 8 years) [ Time Frame: Baseline, year 1 up to year 8 ]
Original Secondary Outcome Measures
 (submitted: February 13, 2009)
  • Incidence rates and recurrence for SAEs and specific events of interest [ Time Frame: Every 6 months for 10 years ]
  • Exposure to Cimzia® or other medications [ Time Frame: Every 3 - 6 months for 10 years ]
  • HBI rating scale [ Time Frame: Every 6 months for 10 years ]
  • Physician's assessment of disease [ Time Frame: Every 3 - 6 months for 10 years ]
  • Patient's disease assessment [ Time Frame: Every 3 - 6 months for 10 years ]
  • Reason for discontinuation of Cimzia® or other medications [ Time Frame: Every 6 months for 10 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry
Official Title A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease
Brief Summary 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 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Crohn's Disease
Intervention Drug: Cimzia
The associated drug description is a total of two 200 mg subcutaneous injections of Cimzia to total 400 mg.
Study Groups/Cohorts
  • 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.
    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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 28, 2017)
3045
Original Estimated Enrollment
 (submitted: February 13, 2009)
4000
Estimated Study Completion Date August 2025
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00844285
Other Study ID Numbers C87075
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UCB Pharma
Study Sponsor UCB Pharma
Collaborators Not Provided
Investigators
Study Director: UCB Cares +1 844 599 2273(UCB)
PRS Account UCB Pharma
Verification Date July 2019