JC-Virus (JCV) Antibody Program (STRATIFY-1)

Biogen

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Drug: Tysabri® (natalizumab)

Study type: Observational

Funder types: Industry

Identifiers

NCT01070823

101JC401

Details and patient eligibility

About

The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.

Full description

This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.

Enrollment: 1,096 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).

Key Exclusion Criteria:

• Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

1,096 participants in 1 patient group

Relapsing Multiple Sclerosis

Description:

Participants receiving or considering treatment with Tysabri® (natalizumab).

Treatment:

Drug: Tysabri® (natalizumab)