Frequently Asked Questions about the Bedaquiline Patient Registry

What are the hours of operation for the BDQ Patient Registry Coordination Center?

The hours of operation are from 8:30 AM to 5:30 PM ET, Monday through Friday. The BDQ Patient Registry Coordination Center (RCC) will be closed on standard holidays. After hours, a message can be left with contact information where the HCP can be reached, and a follow-up call or email will be returned by the next business day.

Where can patients access treatment with SIRTURO™ (BDQ)?

SIRTURO™ (BDQ), in coordination with the Centers for Disease Control and Prevention (CDC), is a limited distribution product, and is available through qualified centers that evaluate, diagnose and treat patients with MDR-TB. Janssen is committed to appropriate and responsible access to BDQ, and it is available by prescription from HCPs associated with centers who have been qualified to prescribe BDQ. If you have questions regarding access to BDQ, please contact Cardinal Health 108 dba Metro Medical at 1-855-691-0963.

Can the enrollment form be emailed so the HCP can fill it out and return it?

Yes. Though the goal is to collect the data in real time in an interview format using forms as a guide for data entry over the phone by talking with the RCC staff; if it is easier to send the forms with the information, forms and other supporting documents may be emailed to the Registry.

Reminder: If the patient data is sent, all forms must be redacted of any personal identifying information.

What is the IRB submission process?

The BDQ Patient Registry protocol has been submitted to the central IRB, WIRB, who has approved that patient consent can be obtained by the HCP and documented using the approved Participant Information Form (PIF). A copy of the signed PIF is given to the patient, and the original remains with the HCP in his/her records. The PIF is not to be sent to the Registry.

Some HCPs require additional approvals by their institutions or partnering hospitals; if additional submissions are required, there is no funding available to compensate for submission fees. Please let the RCC know if this will keep you from enrolling a potential patient and Janssen will be informed.

Is the Registry only for patients with MDR-TB?

No, the Registry will enroll all patients who have been treated with BDQ and meet the enrollment criteria.

How long will the Registry be open?

The BDQ Patient Registry opened on 23 December 2013. Enrollment will be conducted for a 3 year period through December of 2016 and the Registry will close 24 months after the last patient has completed the BDQ treatment that made them eligible for the Registry.

How are patients enrolled?

Participation in the BDQ Patient Registry is voluntary. Patients are enrolled by their HCP who has decided to treat them with BDQ.

If the patient is assessed prior to treatment with BDQ or after BDQ treatment initiation but prior to observation of any patient outcomes for the current course of therapy, then the patient can be enrolled prospectively.

If the patient is assessed after the completion of BDQ treatment or during BDQ treatment and patient treatment outcomes for the current course of therapy have been observed, the patient can be enrolled retrospectively.

Enrollment either prospectively or retrospectively is conditional upon the patient providing consent to participate as documented with the Registry Participant Information Form (PIF).


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