Joint Clinical Trials Office

You are here

SECURE: A Non-Interventional Long-term Post-Marketing Registry of Patients Treated with Certolizumab Pegol (Cimzia®) for Crohn's Disease

Clinical Trial Details

This clinical trial is open for men and women with Crohn’s disease whose physician has determined that these patients will begin taking Cimzia® (certolizumab pegol) or another medication to treat Crohn’s disease. 

The purpose of this observational registry is to collect information on the long-term use and safety of Cimzia as compared to other Crohn's disease medications prescribed by doctors in routine clinical practice. 

This registry study is part of a post-marketing committment from UCB to the FDA. 

This study measures the safety and outcomes among Cimzia patients compared to those that occur while on a different Crohn's disease treatment regimen. 

Study participants will be on this study for approximately 10 years after enrollment, regardless of discontinuation of Cimzia or other medications.

At the enrollment visit, the study participants will be asked to provide demographic information, Crohn’s disease related history and other medical history, study participant’s and physician’s assessment of Crohn’s disease severity and related information.

Follow up period: Every six months study participants will be followed during normal physician visits to collect physician-reported information such as any adverse events, physician’s disease assessment, full details on exposure of Cimzia or other medication, any changes in medication and related information. Every three months, study participants will be followed in the form of web, mail surveys and/or phone follow-up calls to collect patient information such as any major changes in health status, disease assessment, any changes in medication, full details on exposure to Cimzia® or other medications and any administrative changes such as change in contact information.

Enrolled study participants will be followed for approximately 10 years during normal physician visits and through direct patient follow-up in the form of web, mail surveys and/or phone follow-up calls.

Study participants will be compensated in the form of a “Participant Kit” with nominal (small, inexpensive) appreciation gifts for being in this study. The kit is worth about $20.00. The study participants will also receive an appreciation gift worth no more than $20.00 for each survey that they complete (on the web or by phone or via paper).

Key eligibility:

  • Men and women age 18 and older
  • Diagnosis: Crohn’s disease
  • The decision to prescribe Cimzia® or other medications has been made by the physician independently of the   decision to include the patient in the study
  • No participation in randomized, blinded clinical trials for Crohn’s Disease or other conditions
  • Detailed eligibility will be reviewed when you contact the study team at the Jill Roberts Center for Inflammatory Bowel Disease

Study contact by location

Upper East Side - Manhattan

Contact(s)

Fatiha Chabouni
(212) 746-5109
fac2005@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

0906010458

Status

Open to Enrollment

Sponsor