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
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: Interferon beta-1a (Avonex)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 408
Study Start Date: September 1999
Study Completion Date: July 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915460

Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Biogen-Idec Investigator Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00915460     History of Changes
Other Study ID Numbers: C-98-838
Study First Received: June 5, 2009
Last Updated: June 5, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 17, 2014