The trial will study 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 is 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 will be enrolled in this trial. Eligible patients must have a diagnosis of MS as per the McDonald Criteria. In addition, patients must have 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 active disease with at least 1 defined documented relapse in the last year. During a 2 month run-in period, 2 MRIs will be performed 6 weeks apart and patients will be stratified based on the presence or absence of 1 or more Gadolinium enhancing lesions on the first MRI (Gd-enhancing lesion yes-no) and will be randomized to one of two dose regimens of IGIV-C or matching placebo. Patients will receive study drug infusions every 4 weeks for 48 weeks for a total of 12 infusions. Patients will be evaluated by MRI every 6 weeks and by clinical assessments every 3 months. A follow-up visit will occur 4 weeks after the last infusion. The treatment groups are as follows: * IGIV-C - 0.2 g/kg body weight (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 will receive a total volume of 4 ml/kg bw. For patients receiving 0.2 g/kg bw of IGIV-C, the final volume of 4 ml/kg bw will be adjusted by the addition of dextrose 5%. Placebo will be supplied as Albumin 5% or Albumin 25% and diluted with either dextrose 5% or saline to a final concentration of 0.1% albumin. Dose adaptation will be performed for subsequent infusions in case the patient's body weight has changed \> 10%. The maximum amount available per infusion will be 400 ml (8 vials) calculated for a patient with a body weight of 100 kg. The suggested initial infusion rate will be 0.02 ml/kg/min for the first 15 minutes. If there is no evidence of a hypersensitivity reaction, the infusion may be 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 will take approximately 1hour 15 min. The overall infusion time may have a range from 1 to 2 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
Percentage of Relapse Free Subjects (no Relapse)
A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.
Time frame: 12 months
Effect on the Combined Unique Lesion Activity on Magnetic Resonance Imaging (MRI)
Time frame: 1 year
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Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Northwest NeuroSpecialists, PLLC
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The Mt. Sinai Medical Center, Department of Neurology
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SUNY Health Science Center at Stony Brook, Department of Neurology
Stony Brook, New York, United States
Wake Forest University - School of Medicine
Winston-Salem, North Carolina, United States
Neurology Health Care Service, Fletcher Allen Health Care
Burlington, Vermont, United States
Department of Neurology, Karl-Franzens University
Graz, Austria
Foothills Hospital
Calgary, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital, General Campus - Neurology Division
Ottawa, Ontario, Canada
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