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The study was not feasible to conduct in the US and abroad.
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| Name | Class |
|---|---|
| Biogen | INDUSTRY |
This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017 by measuring the nerve fiber thickness in the eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo for 48 weeks, BIIB017 for 48 weeks | Placebo Comparator | Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks. |
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| BIIB017 every 2 weeks for 96 weeks | Experimental | 125 mcg BIIB017 SC every 2 weeks for 96 weeks. |
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| BIIB017 every 4 weeks for 96 weeks | Experimental | 125 mcg BIIB017 SC every 4 weeks for 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB017 | Drug | BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms. | 1 year | |
| To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 24 in the BIIB-17 vs. placebo arms. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 12 in the BIIB-17 vs. placebo arms. | baseline and 1 year | |
| Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Calabresi, MD | Johns Hopkins University | Principal Investigator |
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| baseline and 3 months |
| Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population. | 3 months and 1 year |
| Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population. | baseline and 1 year |
| Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population. | baseline and 1 year |
| Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis. | 1 year |
| Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 24 in the BIIB-17 vs. placebo arms. | baseline and 2 years |
| Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population. | 3 months and 2 years |
| Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population. | baseline and 2 years |
| Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population. | baseline and 2 years |
| Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis. | 2 years |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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