Open-Label Safety Extension Study of Avonex

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2003-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Patients previously enrolled in BIogen Idec study C95-812.

Group Type EXPERIMENTAL

Interferon beta-1a (Avonex)

Intervention Type DRUG

dosage and frequency as per Biogen Idec protocol

2

Patients previously enrolled in Biogen Idec study C96-823.

Group Type EXPERIMENTAL

Interferon beta-1a (Avonex)

Intervention Type DRUG

dosage and frequency as per Biogen Idec protocol

3

Patients previously enrolled in Biogen Idec study C97-830.

Group Type EXPERIMENTAL

Interferon beta-1a (Avonex)

Intervention Type DRUG

dosage and frequency as per Biogen Idec protocol

Interventions

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Interferon beta-1a (Avonex)

dosage and frequency as per Biogen Idec protocol

Intervention Type DRUG

Other Intervention Names

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Avonex

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes