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
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
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).
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.