Open-Label Safety Extension Study of Avonex
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00915460 |
Recruitment Status :
Completed
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Interferon beta-1a (Avonex) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 408 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | 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 |
Study Start Date : | September 1999 |
Actual Primary Completion Date : | June 2003 |
Actual Study Completion Date : | July 2003 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Patients previously enrolled in BIogen Idec study C95-812.
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Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex |
Experimental: 2
Patients previously enrolled in Biogen Idec study C96-823.
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Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex |
Experimental: 3
Patients previously enrolled in Biogen Idec study C97-830.
|
Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex |
- 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 ]
- 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 ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915460
Study Director: | Biogen-Idec Investigator | Biogen |
Responsible Party: | Biogen Idec MD, Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00915460 |
Other Study ID Numbers: |
C-98-838 |
First Posted: | June 8, 2009 Key Record Dates |
Last Update Posted: | June 8, 2009 |
Last Verified: | June 2009 |
Multiple Sclerosis Avonex Interferon beta-1a patients at high risk to develop multiple sclerosis |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Interferons Interferon-beta Interferon beta-1a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |