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Open-Label Safety Extension Study of Avonex

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00915460
First received: June 5, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 5, 2009
June 5, 2009
September 1999
June 2003   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Open-Label Safety Extension Study of Avonex
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

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Multiple Sclerosis
Drug: Interferon beta-1a (Avonex)
dosage and frequency as per Biogen Idec protocol
Other Name: Avonex
  • Experimental: 1
    Patients previously enrolled in BIogen Idec study C95-812.
    Intervention: Drug: Interferon beta-1a (Avonex)
  • Experimental: 2
    Patients previously enrolled in Biogen Idec study C96-823.
    Intervention: Drug: Interferon beta-1a (Avonex)
  • Experimental: 3
    Patients previously enrolled in Biogen Idec study C97-830.
    Intervention: Drug: Interferon beta-1a (Avonex)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
408
July 2003
June 2003   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00915460
C-98-838
Yes
Biogen Idec MD, Biogen Idec
Biogen Idec
Not Provided
Study Director: Biogen-Idec Investigator Biogen Idec
Biogen Idec
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP