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

NCT00784836 | Terminated Phase 3 Results

• 1 other identifier: 108MS303
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis - Relapsing

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)

  The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.

  assessed every 3 months up to 18 months

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Planned for up to 18 months plus 30 days; actual study duration was 111 days.

Study Arms (1)

Avonex

EXPERIMENTAL

Avonex 30 mcg given subcutaneously, once weekly, for 18 months.

Drug: BG9418 (interferon beta 1-a)

Interventions

BG9418 (interferon beta 1-a) DRUG

Also known as: Avonex

Avonex

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Abnormal screening blood tests exceeding any of the limits defined below:
• Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin.
• Total white blood cell count (WBC) \<3700 cells/mm
• Platelet count \<150,000 cells/mm
• Hemoglobin \<10 g/dL in female subjects; \<11 g/dL in male subjects

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MS Center at Texas Neurology

Dallas, Texas, 75214, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Early termination with partial data from 3 subjects, therefore, no statistical analysis performed.

Results Point of Contact

• Title: Biogen Idec Medical Director
• Organization: Biogen Idec Inc.

clinicaltrials@biogenidec.com

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: November 4, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 7, 2014
• Results First Posted: May 7, 2014

Record last verified: 2014-04

Locations

US (2)