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The intent of this study was to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C occurred every 3 weeks. Neurological function was measured by Inflammatory Neuropathy Cause And Treatment (INCAT) scores. Patients who deteriorated or showed no improvement between day 16 and month 6 received the alternate study drug for an additional 6 months.
117 subjects with newly or previously diagnosed CIDP defined by INCAT neurophysiological diagnostic criteria were enrolled into the trial. Patients were not replaced if they discontinued prematurely.
Eligible subjects were randomized to receive either IGIV-C at a dose of 2 g/kg body weight (bw) ideally over 2-4 days, or matching placebo. Thereafter, study drug infusion (IGIV-C or matching placebo) was administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions. Patient's functional disability was measured using the INCAT disability score at baseline, day 16, and at each study visit scheduled every 3 weeks for 6 months. If the INCAT score worsened by ≥1 point at any time between day 16 and month 6 (not including the month 6 visit) relative to baseline, the subject was immediately crossed over to the other study drug. Subjects whose INCAT upper extremity score changed from 0 to 1 or from 1 to 0 had an adjusted INCAT score calculated where this upper extremity change was not incorporated into the adjusted score. Any subject with an adjusted INCAT score change of 0 was deemed a stable patient and was crossed over at week 6.
Upon entering the crossover period, subjects received either IGIV-C at a dose of 2 g/kg bw ideally over 2-4 days or matching placebo. Thereafter, a study drug infusion (IGIV-C or matching placebo) was administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions. A subject was terminated from the study any time between day 16 and 6 months during the crossover period if the INCAT score failed to improve by ≥ 1 point relative to INCAT score at time of crossover. Stable subjects who crossed over at Week 6 remained in the Crossover Treatment Period for 3 weeks before being considered for withdrawal (due to lack of improvement). Any subject who had crossed-over to the alternate study drug was deemed a treatment failure for the primary efficacy analysis.
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