Open-Label Safety Extension Study of Avonex

Biogen408 enrolled

Overview

To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

408

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a (Avonex)DRUG

dosage and frequency as per Biogen Idec protocol

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated. * Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-838. Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-838. * have not been diagnosed with any other disease that accounts for their neurologic symptoms. Exclusion Criteria: * History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta. * History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin. * History of seizure within the 3 months prior to enrollment. * Abnormal laboratory results at the screening visit: * History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study. Other inclusion and exclusion criteria apply as per Biogen Idec Protocol

Outcomes

Primary Outcomes

The primary objective of this study is to collect data on serious adverse events which occur during extended treatment with AVONEX in subjects at high risk for developing MS and in subjects with secondary progressive MS.

Time frame: The study duration is 7 months

Secondary Outcomes

To monitor the occurrence of diagnosed clinically definite multiple sclerosis (CDMS) in subjects who enter this study at high risk for developing MS following an initial demyelinating event.

Time frame: The study duration is 7 months

Data from ClinicalTrials.gov

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