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Open-Label Safety Extension Study of Avonex

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ClinicalTrials.gov Identifier: NCT00915460
Recruitment Status : Completed
First Posted : June 8, 2009
Last Update Posted : June 8, 2009
Sponsor:
Information provided by:
Biogen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Interferon beta-1a (Avonex) Phase 4

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Patients previously enrolled in BIogen Idec study C95-812.
 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

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

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

Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Biogen
Investigators
Study Director: Biogen-Idec Investigator Biogen
More Information
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Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00915460     History of Changes
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

Keywords provided by Biogen:
Multiple Sclerosis
Avonex
Interferon beta-1a
patients at high risk to develop multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple 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