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Immunogenicity and Safety Study of Serum-Free Avonex

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon beta-1a (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Biogen-Idec Investigator, Principal Investigator, Affiliation: Biogen

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®

Secondary outcome: To evaluate the safety of a serum-free pre-formulated solution of AVONEX®

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: January 2003
Last updated: June 5, 2009

Page last updated: August 20, 2015

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