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Safety Assessments Performed The following clinical safety assessmentswere performed:

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a complete physical examination at screening and at study completion, or within 2 weeks from premature discontinuation,

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measurement of vital signs at screening,Day 1 (baseline), and at Months 3,6,9, 12, 15, 1821, and 24, and

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clinician (physician, physician assistant,or nurse) assessmentof the injection site at Day 1 (baseline), and at Months 3,6, 9, 12, 15, 1821, and 24.

The following laboratory safety assessmentswere performed:

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hematology: complete blood count (CBC) with differential and platelet count, aswell PT and aPTT at screening,Day 1 (baseline), and at Months 3,6, 12, 18, and 24; blood chemistry: sodium, potassium, chloride, carbon dioxide, blood urea nitrogen (BUN), creatinine, uric acid, calcium, phosphorus, albumin, total protein, alkaline phosphatase,total bilirubin, ALT, AST, lactic dehydrogenase(LDH), and glucose at screening, Day 1 (baseline), and at Months 3,6, 12, 18, and 24; and

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serum pregnancytest for female subjects who were not postmenopausal or surgically sterile at screening, andat Months 3, 6,9, 12, 15, 18,21, and 24.

The following product-specific safety assessmentswere performed:

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antibody testing. Serum was tested for the presenceof binding antibodies to interferon beta-la using anELISA, and for the presenceandtiter of,neutralizing antibodies to interferon beta-la using an antiviral CPE assayat baseline, and at Months 3, 6, 9, 12, 15, 18,21, and24.

Assessment of Antigenicity The assessmentof antigenicity,was conducted in a two-step assay,asfollows: An ELISA assaywas performed to screenfor the presenceof binding antibodies. If the ELISA results were negative (i.e., <20), no further tests were performed. If the ELISA results were positive, the antiviral CPE assaywas performed to screenfor the presenceof neutralizing antibodies (NAB). The neutralizing titer value was calculated automatically, asa part of the antigenicity bioassay, only if the antiviral CPE assay showed positive sample results.

For analysis purposes,for negative ELISA results, neutralizing antibodies were assumed not present,andthe neutralizing titer value was setto zero. Also, for antiviral CPE assays indicating that the sample was negative for neutralizing antibodies, the neutralizing titer value was setto zero. For caseswith no titer values, the following specifications were utilized to determine titer values.

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If titer is not missing, then the calculated titer = titer value.

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If the titer is missing andthe titer screenis negative then the calculated titer = 0. If the titer is missing andthe titer screeningis missing and ELISA is negative then the calculated titer = 0.

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For all other conditions, the calculated titer is missing.

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