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Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients

A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis

NCT00784836•Biogen

View on ClinicalTrials.gov

Summary

The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
•Male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.
•Must have a diagnosis of relapsing MS.
•Must have a screening Expanded Disability Status Scale (EDSS) score between 0 and 6.0, inclusive.
•All male subjects and female participants of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of Avonex.

Exclusion Criteria

•History of severe allergic or anaphylactic reactions.
•Diagnosed with Primary progressive, secondary progressive, or progressive relapsing MS.
•Known allergy to any component of the Avonex formulation.
•History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease.
•Subjects with history of malignant disease, including solid tumors and hematologic malignancies.
•History of seizure disorder or unexplained blackouts OR 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. Severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy.
•Clinically significant abnormal electrocardiogram (ECG) values as determined by the investigator.
•Known history of, or a positive test result for, human immunodeficiency virus (HIV).
•Known history of, or a positive test result for hepatitis C virus.
+7 more criteria

Locations (2)

Henry Ford Hospital

Detroit, Michigan, United States

MS Center at Texas Neurology

Dallas, Texas, United States

Key Dates

Start Date

October 1, 2008

Primary Completion Date

February 1, 2009

Completion Date

February 1, 2009

Last Updated

May 7, 2014

Enrollment

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

BG9418 (interferon beta 1-a)

DRUG

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

RECRUITINGNA

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients

Inclusion Criteria

Exclusion Criteria

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