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The trial studied 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period.
This trial was designed as a multi-national, randomized, double-blind, placebo-controlled prospective trial with three parallel groups.
One hundred twenty (120) patients, 40 per treatment arm, with relapsing-remitting (RR) multiple sclerosis (MS) were anticipated to be enrolled in this trial. Eligible patients must have had a diagnosis of MS as per the McDonald Criteria. In addition, patients must have had a diagnosis of relapsing-remitting course of MS defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression. Patients must also have had active disease with at least 1 defined documented relapse in the last year.
During a 2 month run-in period, 2 magnetic resonance imagings (MRIs) were performed 6 weeks apart and patients were stratified based on the presence or absence of 1 or more Gadolinium (Gd) enhancing lesions on the first MRI (Gd-enhancing lesion yes-no) and were randomized to one of two dose regimens of IGIV-C or matching placebo. Patients received study drug infusions every 4 weeks for 48 weeks for a total of 12 infusions. Patients were evaluated by MRI every 6 weeks and by clinical assessments every 3 months. A follow-up visit occurred 4 weeks after the last infusion.
The treatment groups were as follows:
- IGIV-C 0.2 g/kg bw/infusion (2 ml/kg bw)
- IGIV-C 0.4 g/kg bw/infusion (4 ml/kg bw)
- Placebo (0.1% albumin) 4 ml/kg bw/infusion
For blinding purposes, at each infusion, all patients received a total volume of 4 ml/kg body weight (bw). For patients receiving 0.2 g/kg bw of IGIV-C the final volume of 4 ml/kg bw) was adjusted by the addition of dextrose 5%. Placebo was supplied as Albumin 5%, USP or Albumin 25%, USP and diluted with either dextrose 5% or saline to a final concentration of 0.1% albumin.
Dose adaptation was performed for subsequent infusions in case the patient's body weight had changed > 10%. The maximum amount available per infusion was 400 ml (8 vials) calculated for a patient with a body weight of 100 kg. The suggested initial infusion rate was 0.02 ml/kg/min for the first 15 minutes. If there was no evidence of a hypersensitivity reaction, the infusion may have been given at a slowly increasing rate over the next 30 minutes up to a maximum allowable rate of 0.08 ml/kg/min. As such, the infusion for a 70 kg patient would take approximately 1 hour 15 min. The overall infusion time may have a range from 1 to 2 hours.
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