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SECURE Cimzia Registry Trial

Clinical Trial Title: 
A noninterventional, long-term, post-marketing registry of patients treated with Certolizumab Pegol (Cimzia) for Crohn’s disease
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Ece Mutlu, MD
Clinical Trial Protocol Description: 

This study is a post-drug approval observational registry designed to monitor the long-term safety of Cimzia when used in customary clinical practice in patients with Crohn’s disease and compared to a non-Cimzia control population. Patients will be included in the Cimzia arm of the registry when they are elected to be treated with Cimzia by their physician. The control group will also be included in the registry when elected by the physician to begin an alternate drug therapy for control of their Crohn’s disease such as first time treatment with steroids, or immunosuppressant treatment such as 6-MP or azathioprine, or anti-TNF treatments Humira, Remicade or Tysabri. Subjects enrolled will be followed for 10 years. The choice of medical treatment will be made independently by the physician in the regular course of practice and will not be influenced by participation in the study protocol. The registry will include 2,000 Cimzia-treated Crohn’s patients and 2,000 patients being treated with other treatment options.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have medically documented Crohn’s disease.
  • Have been started on Cimzia by your medical doctor/gastroenterologist within the past 12 months or have been started for the first time on steroids (e.g. Prednisone), immunosuppressants (e.g. 6-MP or azathioprine) or anti-TNF treatments (e.g. Humira, Remicade or Tysabri) for your Crohn’s within the past 12 months.
  • Have medical documentation about medication use in the past and currently for Crohn’s disease treatment.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Clinical Trial Area: 
Digestive Disorders
Contact Email: 
Contact Phone: 
(312) 942-3466
Contact Name: 
GI Clinical Trials