Immunogenicity and Safety Study of Serum-Free Avonex

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00912860
First received: June 2, 2009
Last updated: June 5, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: Interferon beta-1a
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX® [ Time Frame: Study duration is 20 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety of a serum-free pre-formulated solution of AVONEX® [ Time Frame: The study duration is 20 months ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: January 2003
Study Completion Date: January 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
serum-free avonex given IM
Drug: Interferon beta-1a
serum free Avonex given IM once a week
Other Name: Avonex

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Other inclusion and exclusion criteria apply as per protocol

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912860

Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Biogen-Idec Investigator Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00912860     History of Changes
Other Study ID Numbers: C-867
Study First Received: June 2, 2009
Last Updated: June 5, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
multiple sclerosis
interferon beta-1a
avonex

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 1a
Interferon-beta
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 26, 2014