Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: Natalizumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4 Between the ages of 18 and 55, inclusive Baseline EDSS score between 0.0 and 5.0, inclusive Have been treated with Avonex for at least the 12 months prior to randomization Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization. Cranial MRI scan demonstrating lesions consistent with MS. Have given written informed consent to participate in the study. Exclusion Criteria: Primary progressive, secondary progressive, or progressive relapsing MS. MS relapse has occurred within 50 days of randomization A clinically significant infectious illness within 30 days prior to randomization History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks. History of severe allergic or anaphylactic reactions or known drug hypersensitivity. Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3 Abnormal blood tests at Screening Visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks. | Drug: Natalizumab<br>* Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.<br>* Other names: Tysabri;|
| Placebo Comparator: Group 2<br>Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks. | Drug: Placebo<br>* Placebo monthly infusion for up to 116 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. |  | 1 year and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| If this combination reduces MRI lesions and the overall rate of clinical relapses |  | 1 year and 2 years | 

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