Open-Label Safety Extension Study of Avonex

NCT00915460 | Completed Phase 4 DMC

• 1 other identifier: C-98-838
• Study Type: interventional
• Target: 408
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Avonex; Interferon beta-1a; patients at high risk to develop multiple sclerosis

Outcome Measures

Primary Outcomes (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.

  The study duration is 7 months

Secondary Outcomes (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.

  The study duration is 7 months

Study Arms (3)

1

EXPERIMENTAL

Patients previously enrolled in BIogen Idec study C95-812.

Drug: Interferon beta-1a (Avonex)

2

EXPERIMENTAL

Patients previously enrolled in Biogen Idec study C96-823.

Drug: Interferon beta-1a (Avonex)

3

EXPERIMENTAL

Patients previously enrolled in Biogen Idec study C97-830.

Drug: Interferon beta-1a (Avonex)

Interventions

Interferon beta-1a (Avonex) DRUG

dosage and frequency as per Biogen Idec protocol

Also known as: Avonex

1; 2; 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Biogen-Idec Investigator

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: September 1, 1999
• Primary Completion: June 1, 2003
• Study Completion: July 1, 2003
• Last Updated: June 8, 2009

Record last verified: 2009-06