Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers

Study Overview
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Brief Summary
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This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.

Official Title
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A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control Subjects

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Interferon beta-1a (Avonex)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Control Subjects (Group 1) Must be in general good health. Must not have received interferons in the past. All MS Subjects Clinical or laboratory-supported diagnosis of relapsing remitting MS (McDonald et al, criteria numbers 1-4). Either on AVONEX® or treatment-naïve. Have an EDSS score between 0.0 and 5.5, inclusive. Exclusion Criteria: History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, to other components of the drug formulation. History of intolerance to acetaminophen, ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study. History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease. History of malignancy. The presence of any significant medical condition or psychiatric illness not due to MS that, in the investigator's opinion, would interfere with therapy History of uncontrolled seizures within the 3 months prior to enrollment. History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 8 weeks prior to enrollment. Positive for human immunodeficiency virus (HIV), hepatitis C antibody (HCV) or positive for hepatitis B surface antigen (HbsAg) at screening. Other inclusion and exclusion criteria apply as per protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>Healthy Volunteers | |
| Experimental: Group 2<br>MS patients previously naïve to interferon therapy | Drug: Interferon beta-1a (Avonex)<br>* 30 mcg by intramuscular injection once a week<br>* Other names: Avonex;|
| Experimental: Group 3<br>MS patients on Interferon beta-1a treatment with no history of breakthrough disease (clinically stable) | Drug: Interferon beta-1a (Avonex)<br>* 30 mcg by intramuscular injection once a week<br>* Other names: Avonex;|
| Experimental: Group 4<br>MS patients on interferon beta-1a treatment with a history of breakthrough disease. | Drug: Interferon beta-1a (Avonex)<br>* 30 mcg by intramuscular injection once a week<br>* Other names: Avonex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bioanalytical measures after receiving therapy for 3 to 6 months |  | Study duration is 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis