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.
Drug: Interferon beta-1a
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Full eligibility criteria for NCT00912860
Ages eligible for Study
18 Years to 60 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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
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Tris trial is registered with FDA with number: NCT00912860. The sponsor of the trial is Biogen and it is looking for 155 volunteers for the current phase.
Official trial title: A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis
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