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OpenTrials
Completed

NCT Number: NCT00912860

Immunogenicity and Safety Study of Serum-Free Avonex

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interferon beta-1a

Drug

serum free Avonex given IM once a week

Other names: Avonex

Primary outcomes

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

    Time frame: Study duration is 20 months

Secondary outcomes

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

    Time frame: The study duration is 20 months

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Jun 3, 2009
Registry last updated
Jun 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.