Back to resultsImmunogenicity and Safety Study of Serum-Free Avonex
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Interferon beta-1a
Sponsored by
About this trial
This is an interventional basic science trial for Multiple Sclerosis focused on measuring multiple sclerosis, interferon beta-1a, avonex
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
serum-free avonex given IM
Outcomes
Primary Outcome Measures
To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®
Secondary Outcome Measures
To evaluate the safety of a serum-free pre-formulated solution of AVONEX®
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00912860
Brief Title
Immunogenicity and Safety Study of Serum-Free Avonex
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, interferon beta-1a, avonex
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
serum-free avonex given IM
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Other Intervention Name(s)
Avonex
Intervention Description
serum free Avonex given IM once a week
Primary Outcome Measure Information:
Title
To evaluate the immunogenicity of a serum-free pre-formulated solution of AVONEX®
Time Frame
Study duration is 20 months
Secondary Outcome Measure Information:
Title
To evaluate the safety of a serum-free pre-formulated solution of AVONEX®
Time Frame
The study duration is 20 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biogen-Idec Investigator
Organizational Affiliation
Biogen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of Serum-Free Avonex
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