- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00784836
Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients
April 7, 2014 updated by: Biogen
A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Texas
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Dallas, Texas, United States, 75214
- MS Center at Texas Neurology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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
- Serum creatinine >upper limit of normal (ULN)
- Prothrombin time (PT) or activated partial thromboplastin time (aPTT) > 1.2*ULN
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Avonex
Avonex 30 mcg given subcutaneously, once weekly, for 18 months.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)
Time Frame: assessed every 3 months up to 18 months
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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.
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assessed every 3 months up to 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Planned for up to 18 months plus 30 days; actual study duration was 111 days.
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AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product.
SAE: any untoward medical occurrence that at any dose: results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect.
An SAE may also be any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
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Planned for up to 18 months plus 30 days; actual study duration was 111 days.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
February 1, 2009
Study Completion (ACTUAL)
February 1, 2009
Study Registration Dates
First Submitted
October 29, 2008
First Submitted That Met QC Criteria
November 3, 2008
First Posted (ESTIMATE)
November 4, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
May 7, 2014
Last Update Submitted That Met QC Criteria
April 7, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Adjuvants, Immunologic
- Interferons
- Interferon beta-1a
- Interferon-beta
Other Study ID Numbers
- 108MS303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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