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

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 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.

Description

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.

Eligible subjects will be 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) will be 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 will be 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 worsens by ≥1 point at any time between day 16 and month 6 (not including the month 6 visit) relative to baseline, the subject will be immediately crossed over to the other study drug. Subjects whose INCAT upper extremity score changes from 0 to 1 or from 1 to 0 will have an adjusted INCAT score calculated where this upper extremity change is not incorporated into the adjusted score. Any subject with an adjusted INCAT score change of 0 will be deemed a stable patient and will be crossed over at week 6.

Upon entering the crossover period, subjects will receive 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) will be 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 will be terminated from the study any time between day 16 and 6 months during the crossover period if the INCAT score fails to improve by ≥1 point relative to INCAT score at time of crossover. Stable subjects who crossed over at Week 6 must remain in the Crossover Treatment Period for 3 weeks before being considered for withdrawal (due to lack of improvement). Any subject who has been crossed-over to the alternate study drug will be deemed a treatment failure for the primary efficacy analysis.

Randomization will be within each center. Eight randomization numbers, which constitutes one or more full random blocks, will be assigned to each center. A random number will be assigned to subjects in ascending order.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, Albumin (Human) 25%, USP

Location

Yale University School of Medicine
New Haven
Connecticut
United States
06520-8018

Status

Completed

Source

Talecris Biotherapeutics

Results (where available)

View Results

Links

• Source: http://clinicaltrials.gov/show/NCT00220740
• Information obtained from ClinicalTrials.gov on July 15, 2010

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