A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a

Study Overview
=================
Brief Summary
-----------------
Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRIÂ®) or Interferon beta-1a (AVONEXÂ®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).

Official Title
-----------------
Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a

Conditions
-----------------
Relapsing-Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: TYSABRI and AVONEX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of RRMS. Patients with unilateral AON consistent with Multiple Sclerosis (MS). Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset. Age 18-55 years. Expanded Disability Status Scale (EDSS) 0 to 5.0. Understand and sign informed consent. Exclusion Criteria: History or presence of progressive multifocal leukoencephalopathy (PML). Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS). Immune-compromised in the judgment of the Investigator. History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study. Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc). Previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis (ON) with the most recent ON symptom onset being less than 12 months ago. Previous treatment with > 1 Disease Modifying Therapy (DMT). Previous treatment with investigational products for MS, immunosuppressant or cytotoxic therapy. Previous treatment with TYSABRI® Women who are not postmenopausal, surgically sterile, or willing to practice contraception. Women pregnant, breast feeding, or planning to become pregnant. Involved with other study protocol simultaneously without prior approval. Determined not suitable for study participation by Investigator and/or Sponsor.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: TYSABRI<br> | Drug: TYSABRI and AVONEX<br>* TYSABRI and AVONEX treatment per package insert.<br>|
| No Intervention: AVONEX<br> | Drug: TYSABRI and AVONEX<br>* TYSABRI and AVONEX treatment per package insert.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups. |  | Between week 4 and weeks 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups. |  | Between week 4 and weeks 36 |