JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri: STRATIFY-2

Study ID
Study00002357

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Janida Carter
903/327-3370
janida.carter@utsouthwestern.edu

Principal Investigator
Benjamin Greenberg

Summary

STuDY DeSiGn
enrollment
This is an observational, longitudinal cohort study. all patients with relapsing MS treated with Tysabri or who are considering beginning treatment with Tysabri are eligible to participate.

Patients who are about to begin treatment with Tysabri may enroll into STRaTiFY-2 prior to enrolling into the TouCH Prescribing Program.

Patients who are already receiving Tysabri at the time of enrollment into STRaTiFY-2 and their prescribers must be enrolled in the TouCH Prescribing Program before enrollment into this study.

Patients participating in any other Tysabri clinical trial or study sponsored by Biogen idec or elan may not participate in this study.

Site personnel will administer informed consent to eligible patients prior to any study procedures taking place. The original informed Consent Forms (iCF) and documentation of the consent process will be retained in the patient record at the Prescribing Physician's site.

Sample Collection Process
after the patient has provided written informed consent, a serum sample will be collected to be tested for JCV antibodies. a serum sample will then be collected annually for up to 4 years for JCV antibody testing. all samples will be sent to a central laboratory. Results of the serum JCV antibody tests (detectable/not detectable) will be provided to the Prescribing Physician. Remaining serum aliquots will be stored for future JCV research. if a sample collection is not received approximately 1 and 2 years after enrollment, a reminder will be sent to the Prescribing Physician.

Relevant patient data will be collected using a provided laboratory requisition forms. Copies of the laboratory requisition forms are to be kept at the Prescribing Physician's site in the patient record.

There are no study mandated visits. Samples will be collected during routine patient care or follow-up visits at or about 1 and 2 years after the initial sample collection at enrollment.

no treatment is provided in this study. Patients may withdraw from the study at any time, for any reason. if a patient discontinues Tysabri, they will be withdrawn from this study.

information Collected at enrollment
The Prescribing Physician will collect the following information at enrollment:
* informed consent for participation in the study
* Serum collection for JCV antibody testing and storage for future JCV research
* information on laboratory requisition form: date and time of sample collection, patient information (initials, date of birth, gender, patient TouCH iD, if applicable), prescriber name, site number, and date informed consent was obtained

information Collected every 12 Months for up to 4 Years From enrollment
* Serum collection for JCV antibody testing and storage for future JCV research
* information on laboratory requisition form: date and time of sample collection, patient information (initials, date of birth, gender, patient TouCH iD, if applicable), prescriber name, site number, and date informed consent was
obtained

additional, optional Sample Collection:
additional samples may be collected for those patients that have taken medications that suppress the immune system, anD have received more than 12 infusions of Tysabri (and most likely will have received 24 or more infusions of Tysabri before the program ends), anD have provided samples that were positive for the anti-JCV antibody in STRaTiFY 2. These samples will be stored for future Tysabri and PML research and to identify biomarkers that may help to further define the risk of developing PML.

Participant Eligibility

This is an observational, longitudinal cohort study. All patients with relapsing MS treated with Tysabri or who are considering beginning treatment with Tysabri are eligible to participate.