Purpose and methods

The purpose of the study is to obtain safety and outcome data on rheumatoid arthritis (RA) patients receiving certolizumab pegol (Cimzia®) and other RA treatments. Please note that this purpose is broader than just the evaluation of certolizumab pegol.

To conduct this study we will evaluate patients at 6-month intervals by mailed or Internet patient questionnaires. We will validate reports of serious medical outcomes by medical record review. A copy of our evaluation form is available at www.ndbCimzia®.org

Agreement

What you agree to do. By participating in this study you agree to identify eligible certolizumab pegol and control patients, explain the study to them, and obtain informed consents and patient registration forms; and to provide follow-up information to the NDB regarding patient treatment and adverse event status, from time to time, only if requested, unless the patient revokes consent.

What the patient will do. The patients will complete an RA outcomes questionnaire every 6 months.

Enrollment and how to enroll patient

Eligible patients. A certolizumab pegol patient eligible for enrollment is a patient in your practice who will start certolizumab pegol or has started certolizumab pegol within the last 6 months — whether or not the patient is still receiving that treatment. The certolizumab pegol patient must be able to read, write and speak English.

A control patient eligible for enrollment is a patient who will start a non-biologic DMARD or has started a non-biologic DMARD within the last 6 months —whether or not the patient is still receiving that treatment. The control patient must be able to read, write and speak English.

How many patients you may enroll. You may enroll as many patients as you wish, but not more than 4 control patients for each certolizumab pegol patient you enroll. You agree to enroll at least 2 control patients for each certolizumab pegol patient.

Order of enrollment. You may enroll up to 2 control patients before enrolling the first certolizumab pegol patient.