The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.
This is a Double Blind, Randomized study. All subjects will enter a wash-out phase of up to 12 weeks, or until functional deterioration, defined as an increase of ≥1 point (worsening) in the adjusted INCAT disability score, is demonstrated. Eligible subjects will then be randomized in a 1:2 ratio to receive either 0.5 g/kg or 1.0 g/kg KIg10 at 3-weekly intervals for 21 weeks. Subjects who relapse during randomized treatment due to functional deterioration, based on the INCAT score, will be rescued with 2.0 g/kg KIg10 at 3-weekly intervals for 21 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
161
Kedrion intravenous immunoglobulin (IVIg) 10%
Advanced Neurology Epilepsy and Sleep Center/ANESC Research
El Paso, Texas, United States
RECRUITINGEfficacy of 1.0 g/kg KIg10 in the treatment of adult subjects with active CIDP
The proportion of responders in the 1.0 g/kg KIg10 arm, at week 24 relative to Randomization Baseline week 0, based on the adjusted INCAT disability score. A responder is defined as having a ≥1 point decrease (improvement) in the adjusted INCAT score at week 24 relative to adjusted INCAT score at randomization baseline.
Time frame: From Baseline upto 24 weeks of treatment
Efficacy of 0.5 g/kg KIg10 in the treatment of adult subjects with active CIDP
The proportion of responders in the 0.5 g/kg KIg10 arm at week 24 relative to randomization baseline, based on the adjusted INCAT disability score. A responder is defined as having a ≥1 point decrease (improvement) in the adjusted INCAT score at week 24 relative to adjusted INCAT score at randomization baseline.
Time frame: From Baseline upto 24 weeks of treatment
Proportion of responders (Week 24 vs Baseline) in both dose groups
Proportion of responders in both dose groups based on Grip Strength and I-RODs
Time frame: From Baseline upto 24 weeks of treatment
Proportion of responders in rescued subjects
Proportion of responders in rescued subjects based on grip strength, I-RODS scores, adjusted INCAT disability score
Time frame: End of Treatment vs onset of rescue treatment
Improvers based on the MRC-sumscore
Improvers by a change of 4 points in both dose groups (week 24 versus baseline) based on MRC-sumscore
Time frame: From Baseline upto 24 weeks of treatment
Mean Change in MRC-sumscore
Mean change in MRC-sumscore for both dose groups at week 24 vs baseline
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Time frame: From Baseline upto 24 weeks of treatment
Mean Change in MRC-sumscore for rescued subjects
Mean change in MRC-sumscore for rescued subjects from End of Treatment versus onset of rescue treatment
Time frame: End of Treatment vs onset of rescue treatment
Disease Related QoL (CAPPRI) for each dose level
For each dose level the Chronic Acquired Polyneuropathy Patient Reported Index (CAPPRI) will be analysed for disease related QoL
Time frame: From Baseline upto 24 weeks of treatment
Mean change in I-RODS
For each dose level, mean change from randomization baseline (visit 2, week 0) to end of study (visit 10, week 24) in Inflammatory-Rasch-built Overall Disability Scale (I- RODS) score
Time frame: From Baseline upto 24 weeks of treatment
Mean change in I-RODS for rescued subjects
Mean change to the end of treatment assessments prior to onset of rescue treatment, in Inflammatory-Rasch-built Overall Disability Scale (I- RODS) score for rescued subjects
Time frame: End of Treatment vs onset of rescue treatment