Open-Label Safety Extension Study of Avonex

Study Overview
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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.

Official Title
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An Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1a (Avonex)


Participation Criteria
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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. Other inclusion and exclusion criteria apply as per Biogen Idec Protocol
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients previously enrolled in BIogen Idec study C95-812. | Drug: Interferon beta-1a (Avonex)<br>* dosage and frequency as per Biogen Idec protocol<br>* Other names: Avonex;|
| Experimental: 2<br>Patients previously enrolled in Biogen Idec study C96-823. | Drug: Interferon beta-1a (Avonex)<br>* dosage and frequency as per Biogen Idec protocol<br>* Other names: Avonex;|
| Experimental: 3<br>Patients previously enrolled in Biogen Idec study C97-830. | Drug: Interferon beta-1a (Avonex)<br>* dosage and frequency as per Biogen Idec protocol<br>* Other names: Avonex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | The study duration is 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | The study duration is 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Avonex, Interferon beta-1a, patients at high risk to develop multiple sclerosis