Immunogenicity and Safety Study of Serum-Free Avonex

Biogen

Status and phase

Completed

Phase 2

Conditions

Multiple Sclerosis

Treatments

Drug: Interferon beta-1a

Study type

Interventional

Funder types

Industry

Identifiers

NCT00912860

C-867

Details and patient eligibility

About

To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given to interferon beta naive patients with relapsing/remitting multiple sclerosis.

Enrollment

155 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must have a diagnosis of relapsing/remitting MS as defined by McDonald, et al15; criteria numbers 1-4.
Must have an expanded disability status scale (EDSS) score between 0 and 5.5, inclusive.
Must be able to understand and comply with the protocol.

Exclusion criteria

Has experienced a relapse within 2 months prior to Day 1. Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 48 hours, and accompanied by new objective neurological findings upon examination by the investigator.
History of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would preclude therapy with interferon beta.
Abnormal screening or baseline blood tests determined to be clinically significant by the investigator
History of a seizure within 3 months prior to Day 1.
History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1.
Known allergy to natural rubber latex.

Other inclusion and exclusion criteria apply as per protocol