Clinical Trial: Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Infla

Brief Summary: The intent of this study is 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 will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.

Detailed Summary: 110 subjects, 55 per treatment group, with newly or previously diagnosed CIDP defined by INCAT neurophysiological diagnostic criteria will be enrolled into the trial. Patients will not be replaced if they discontinue prematurely.
Sponsor: Grifols Therapeutics Inc.

Current Primary Outcome: Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period [ Time Frame: 6 months ]

The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period.

Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10.

INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement.

INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help



Original Primary Outcome: ≥ 1 point improvement in the INCAT score relative to baseline at 6 months (without crossing over) or the last INCAT assessment after the first study drug infusion (crossing over). Any subject who crosses over will be considered a non-responder.

Current Secondary Outcome:

  • Mean Change in the Amplitude (Millivolts) in the Most Severely Affected Motor Nerve During the Efficacy Period [ Time Frame: 6 months ]
    Mean changes in amplitude [mV] measured at most proximal site in the most severely affected motor nerve from baseline to endpoint during the Efficacy Period (Intent to treat population)
  • Mean Change in Grip Strength During the Efficacy Period [ Time Frame: 6 months ]
  • Time to Relapse for Subjects Who Were IGIV-C Responders or IGIV-C Rescue Successes, During the Randomized Withdrawal Period [ Time Frame: 6 months ]


Original Secondary Outcome:

  • - Mean change in the amplitude (millivolts) in the most severely affected motor nerve
  • - Change in grip strength
  • - Time to relapse


Information By: Grifols Therapeutics Inc.

Dates:
Date Received: September 13, 2005
Date Started: April 2004
Date Completion:
Last Updated: February 23, 2016
Last Verified: February 2016