Immunogenicity and Safety Study of Serum-Free Avonex

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00912860

Enrollment

155

Registered

2009-06-03

Start date

2003-01-31

Completion date

2005-01-31

Last updated

2009-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, interferon beta-1a, avonex

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.

Interventions

DRUGInterferon beta-1a

serum free Avonex given IM once a week

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®	Study duration is 20 months

Secondary

Measure	Time frame
To evaluate the safety of a serum-free pre-formulated solution of AVONEX®	The study duration is 20 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026