Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy

Teva Pharmaceuticals

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Procedure: NAbs testing

Study type: Observational

Funder types: Industry

Identifiers

NCT00336557

PM028

Details and patient eligibility

About

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Full description

An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.

Enrollment: 1,230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to provide informed consent.
• Male or female, 18 years of age or older, with a diagnosis of MS.

Exclusion criteria

• Has been on oral or parenteral corticosteroid therapy within the two weeks prior to the Baseline Visit.
• Has been treated with immunoglobulins (IgG) or plasmapheresis within the last six months.
• Has any condition which the investigator or nurse feels may interfere with participation in the study or with assessments for the full duration of the study.
• Previously participated in this study.
• Has received an experimental drug in the last thirty (30) days.

Trial design

1,230 participants in 2 patient groups

Regularly Scheduled NAb Testing Arm

Description:

Subjects will be scheduled for 5 study visits over the course of 12 months and any NAbs test results will be available to the investigator during the study.

Treatment:

Procedure: NAbs testing

Usual Care Arm

Description:

Subjects will be scheduled for 2 study visits over the course of 12 months and any NAbs test results will be unknown by the investigator until the conclusion of the subject's study participation.