Immunogenicity and Safety Study of Serum-Free Avonex

NCT ID: NCT00912860

Last Updated: 2009-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

serum-free avonex given IM

Group Type EXPERIMENTAL

Interferon beta-1a

Intervention Type DRUG

serum free Avonex given IM once a week

Interventions

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Interferon beta-1a

serum free Avonex given IM once a week

Intervention Type DRUG

Other Intervention Names

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Avonex

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Biogen Idec

Principal Investigators

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Biogen-Idec Investigator

Role: PRINCIPAL_INVESTIGATOR

Biogen

Other Identifiers

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C-867

Identifier Type: -

Identifier Source: org_study_id

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