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
What it found
We found no results in the registry or in papers.
This trial finished 21 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®
Study duration is 20 months
Immune response
Other measures (1)
To evaluate the safety of a serum-free pre-formulated solution of AVONEX®
The study duration is 20 months
Safety
Who could take part
MS (type not specified) · 18 to 60 · EDSS 0 to 5.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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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History
Started
Jan 2003
Main results due
Dec 2004
Finished
Jan 2005