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Sponsor decision to withdraw study at this time.
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Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TYSABRI | Experimental |
| |
| AVONEX | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TYSABRI and AVONEX | Drug | TYSABRI and AVONEX treatment per package insert. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
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