Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified; Albumin (Human) 25%, United States Pharmacopeia (USP)
Intervention type(s): Drug; Drug
Other intervention name(s): Gamunex®; IGIVnex®; Gaminex; IGIV-C; Immune Globulin Intravenous (Human) , 10%; IGIV; BAY 41-1000; TAL-05-00004; IGIV-C, 10%; IVIG; Immune Globulin (Human), 10% (IGIV); Immune Globulin Intravenous, 10% by Chromatography Process; NDC 13533-645-12; NDC 13533-645-15; NDC 13533-645-20; NDC 13533-645-24; NDC 13533-645-71; Plasbumin®-5; Plasbumin®-25; Plasbumin®-5 (Low Aluminum); Plasbumin®-25 (Low Aluminum); Albumin (Human) 5%, USP; Albumin (Human) 25%, USP; TAL-05-00009; TAL-05-00023; TAL-05-00025; TAL-05-00026; BAY 34-9255; NDC 13533-684-16; NDC 13533-684-25; NDC 13533-684-71; NDC 13533-685-20; NDC 13533-685-25; NDC 13533-685-27; NDC 13533-690-20; NDC 13533-690-25; NDC 13533-690-27; NDC 13533-692-16; NDC 13533-692-20; NDC 13533-692-71
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment