Immunogenicity and Safety Study of Serum-Free Avonex

NCT00912860 | Completed Phase 2

• 1 other identifier: C-867
• Study Type: interventional
• Target: 155
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given to interferon beta naive patients with relapsing/remitting multiple sclerosis.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; interferon beta-1a; avonex

Outcome Measures

Primary Outcomes (1)

• To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®

  Study duration is 20 months

Secondary Outcomes (1)

• To evaluate the safety of a serum-free pre-formulated solution of AVONEX®

  The study duration is 20 months

Study Arms (1)

1

EXPERIMENTAL

serum-free avonex given IM

Drug: Interferon beta-1a

Interventions

Interferon beta-1a DRUG

serum free Avonex given IM once a week

Also known as: Avonex

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must have a diagnosis of relapsing/remitting MS as defined by McDonald, et al15; criteria numbers 1-4.
• Must have an expanded disability status scale (EDSS) score between 0 and 5.5, inclusive.
• Must be able to understand and comply with the protocol.

You may not qualify if:

• Has experienced a relapse within 2 months prior to Day 1. Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 48 hours, and accompanied by new objective neurological findings upon examination by the investigator.
• History of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would preclude therapy with interferon beta.
• Abnormal screening or baseline blood tests determined to be clinically significant by the investigator
• History of a seizure within 3 months prior to Day 1.
• History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1.
• Known allergy to natural rubber latex.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 3, 2009
• Study Start: January 1, 2003
• Primary Completion: December 1, 2004
• Study Completion: January 1, 2005
• Last Updated: June 10, 2009

Record last verified: 2009-06