The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Study Site
Brussels, Belgium
Study Site
Edegem, Belgium
Study Site
Ghent, Belgium
Responder Rate
Percentage of responders based on the adjusted Inflammatory Neuropathy Cause and Treatment Scale (INCAT) score. Responders were defined as those subjects who: 1) demonstrated a "clinically meaningful improvement" between baseline and Week 25, or 2) who were discontinued from the study for any reason after the start of IgPro10 treatment but with "clinically meaningful improvement" at the last study visit. "Clinically meaningful improvement" was a decrease of at least 1 adjusted INCAT score point excluding an improvement of one point in the total score if this improvement was only due to a decrease in the upper limb score of 1 to 0.
Time frame: 25 weeks
Change in Adjusted INCAT Score
The change in INCAT score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. The INCAT disability score ranges from 0 to 10 and is the sum of arm and leg disability each rated between 0 and 5 (where arm = 0 indicates 'no upper limb problems' and arm = 5 indicates 'inability to use either arm for any purposeful movement', and leg = 0 indicates 'walking not affected', and leg = 5 indicates 'restricted to wheelchair, unable to stand and walk a few steps with help'). Thus, a higher INCAT disability score indicates greater disability. Negative values for change in INCAT score indicate improvement, with a more negative value indicating greater improvement compared with the value at baseline.
Time frame: Up to 34 weeks
Change in Maximum Grip Strength
Change in maximum grip strength of the dominant hand. A non-parametric analysis was used to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. Positive values for change in maximum grip strength indicate improvement.
Time frame: Up to 34 weeks
Change in Medical Research Council Sum Scale (MRC)
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Study Site
Leuven, Belgium
Study Site
Helsinki, Finland
Study Site
Turku, Finland
Study Site
Vaasa, Finland
Study Site
Limoges, France
Study Site
Lyon, France
Study Site
Marseille, France
...and 12 more locations
The change in MRC sum score was determined at the completion visit compared to baseline and to the last measurement under the previous IVIG treatment using a non-parametric analysis to calculate the Hodges-Lehmann point estimate and the corresponding Tukey confidence interval on an exploratory basis. The 80-point MRC sum score is the sum of scores for eight bilateral (left and right side) muscle groups, each rated between 0 (no visible contraction) to 5 (normal movement). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline.
Time frame: Up to 34 weeks
Immunoglobulin G (IgG) Level
Time frame: At baseline and at Weeks 7, 13 and 19 (levels determined immediately before and after IVIG infusion), and at completion visit (Week 25)
Frequency of Adverse Events (AEs)
Overall rate of AEs per infusion.
Time frame: For the duration of the study, up to 34 weeks
Severity of AEs Per Infusion
The severity of each AE was to be graded by the investigator as follows: * Mild: Symptoms were easily tolerated and there was no interference with daily activities. * Moderate: Discomfort enough to cause some interference with daily activities. * Severe: Incapacitating with inability to work or do usual activity.
Time frame: For the duration of the study, up to 34 weeks
Severity of AEs Per Subject
The severity of each AE was to be graded by the investigator as follows: * Mild: Symptoms were easily tolerated and there was no interference with daily activities. * Moderate: Discomfort enough to cause some interference with daily activities. * Severe: Incapacitating with inability to work or do usual activity.
Time frame: 34 weeks
Relatedness of AEs Per Infusion
The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.
Time frame: For the duration of the study, up to 34 weeks
Relatedness of AEs Per Subject
The causal relationship of an AE to the study drug was to be assessed and assigned by the investigator.
Time frame: For the duration of the study, up to 34 weeks
Mean Change in Systolic and Diastolic Blood Pressure During Infusion
Systolic and diastolic blood pressure (BP) were measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and standard deviation (SD) of these individual mean changes is reported.
Time frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Mean Change in Pulse Rate During Infusion
Pulse rate was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.
Time frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Mean Change in Body Temperature During Infusion
Body temperature was measured before the start of IgPro10 infusion, at 30 minutes and 1 hour after the start of infusion, then every hour until the end of infusion and at 1 hour after the end of infusion. Mean changes from the pre-infusion value to each of the post-infusion values were calculated for each infusion, and the mean value and SD of these individual mean changes is reported.
Time frame: At Days 1 to 5 and at Weeks 4, 7, 10, 13, 16, 19 and 22.
Number of Subjects With Normal/Abnormal Not Clinically Significant (ANCS) Value at Baseline Changing to Abnormal Clinically Significant (ACS) Value at Completion Visit in Routine Laboratory Parameters.
Number of subjects with changes from normal/ANCS values at baseline to ACS values at Completion Visit in routine laboratory parameters including hematology and serum chemistry analytes. Investigators flagged each laboratory value as normal, ANCS or ACS at each assessment timepoint.
Time frame: At Day 1 (baseline) and at Completion Visit (Week 25 or early discontinuation)