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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01545076
Registration number
NCT01545076
Ethics application status
Date submitted
1/03/2012
Date registered
6/03/2012
Date last updated
5/07/2018
Titles & IDs
Public title
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
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Scientific title
Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study
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Secondary ID [1]
0
0
IgPro20_3003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Inflammatory Demyelinating Polyneuropathy
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0
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Polyradiculoneuropathy
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0
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Condition category
Condition code
Neurological
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0
0
0
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Other neurological disorders
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Inflammatory and Immune System
0
0
0
0
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Autoimmune diseases
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Neurological
0
0
0
0
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Neurodegenerative diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - IgPro20 (low dose)
Treatment: Other - Placebo
Treatment: Other - IgPro10
Treatment: Other - IgPro20 (high dose)
Experimental: IgPro20 low dose -
Experimental: IgPro20 high dose -
Placebo comparator: Placebo -
Treatment: Other: IgPro20 (low dose)
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:
0.2 g/kg body weight (low dose arm)
Treatment: Other: Placebo
2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Treatment: Other: IgPro10
10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse.
Treatment: Other: IgPro20 (high dose)
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:
0.4 g/kg body weight (high dose arm)
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
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Assessment method [1]
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Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score). The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
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Timepoint [1]
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Up to 25 weeks
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Secondary outcome [1]
0
0
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
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Assessment method [1]
0
0
The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
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Timepoint [1]
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Baseline and up to 25 weeks
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Secondary outcome [2]
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Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
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Assessment method [2]
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The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
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Timepoint [2]
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0
Baseline and up to 25 weeks
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Secondary outcome [3]
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Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
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Assessment method [3]
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An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
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Timepoint [3]
0
0
Baseline and up to 25 weeks
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Secondary outcome [4]
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Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
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Assessment method [4]
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The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
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Timepoint [4]
0
0
Baseline and up to 25 weeks
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Secondary outcome [5]
0
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Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
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Assessment method [5]
0
0
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Timepoint [5]
0
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Up to 25 weeks
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Secondary outcome [6]
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Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
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Assessment method [6]
0
0
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Timepoint [6]
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0
Up to 28 weeks
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Secondary outcome [7]
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Number of Subjects With Adverse Events During the SC Treatment Period
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Assessment method [7]
0
0
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Timepoint [7]
0
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Up to 28 weeks
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Secondary outcome [8]
0
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Percentage of Subjects With Adverse Events During the SC Treatment Period
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Assessment method [8]
0
0
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Timepoint [8]
0
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Up to 28 weeks
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Secondary outcome [9]
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Time to Improvement During IgPro10 Re-stabilization Therapy
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Assessment method [9]
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Improvement is defined as an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, Mean Grip strength improvement by at least 8 kPa in one hand, or MRC Sum score \>=3.
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Timepoint [9]
0
0
Up to 13 weeks
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Secondary outcome [10]
0
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Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
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Assessment method [10]
0
0
The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
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Timepoint [10]
0
0
Reference visit and up to 13 weeks
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Secondary outcome [11]
0
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Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
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Assessment method [11]
0
0
An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
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Timepoint [11]
0
0
Reference visit and up to 13 weeks
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Secondary outcome [12]
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0
Change in R-ODS During IgPro10 Re-stabilization Therapy
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Assessment method [12]
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The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
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Timepoint [12]
0
0
Reference visit and up to 13 weeks
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Secondary outcome [13]
0
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Change in INCAT During IgPro10 Re-stabilization Therapy
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Assessment method [13]
0
0
The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
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Timepoint [13]
0
0
Reference visit and up to 13 weeks
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Secondary outcome [14]
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Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
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Assessment method [14]
0
0
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Timepoint [14]
0
0
Up to 13 weeks
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Secondary outcome [15]
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0
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
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Assessment method [15]
0
0
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Timepoint [15]
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0
Up to 13 weeks
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Secondary outcome [16]
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0
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
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Assessment method [16]
0
0
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Timepoint [16]
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0
Up to 13 weeks
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Secondary outcome [17]
0
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Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
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Assessment method [17]
0
0
Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline score..The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
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Timepoint [17]
0
0
Up to 13 weeks
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Secondary outcome [18]
0
0
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
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Assessment method [18]
0
0
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Timepoint [18]
0
0
Up to 13 weeks
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Secondary outcome [19]
0
0
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
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Assessment method [19]
0
0
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Timepoint [19]
0
0
Up to 13 weeks
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Secondary outcome [20]
0
0
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
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Assessment method [20]
0
0
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Timepoint [20]
0
0
Up to 13 weeks
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Secondary outcome [21]
0
0
Change in Mean Grip Strength During IgPro10 Rescue Therapy
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Assessment method [21]
0
0
The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
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Timepoint [21]
0
0
Before first rescue IgPro10 infusion and up to 13 weeks
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Secondary outcome [22]
0
0
Change in MRC Sum Score During IgPro10 Rescue Therapy
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Assessment method [22]
0
0
An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
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Timepoint [22]
0
0
Before first rescue IgPro10 infusion and up to 13 weeks
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Secondary outcome [23]
0
0
Change in R-ODS During IgPro10 Rescue Therapy
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Assessment method [23]
0
0
The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
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Timepoint [23]
0
0
Before first rescue IgPro10 infusion and up to 13 weeks
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Secondary outcome [24]
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0
Change in INCAT During IgPro10 Rescue Therapy
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Assessment method [24]
0
0
The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 ("No upper limb problems") to 5 ("Inability to use either arm for any purposeful movement"), and scores for leg disability range from 0 ("Walking not affected") to 5 ("Restricted to wheelchair, unable to stand and walk a few steps with help"). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the "adjusted" INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant.
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Timepoint [24]
0
0
Before first rescue IgPro10 infusion and up to 13 weeks
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Eligibility
Key inclusion criteria
* Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
* An IVIG treatment during the last 8 weeks prior to enrollment.
* Age =18 years.
* Written informed consent for study participation obtained before undergoing any study-specific procedures.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any polyneuropathy of other causes
* Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
* Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
* History of thrombotic episodes within the 2 years prior to enrolment
* Known allergic or other severe reactions to blood products including intolerability to previous IVIG
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2016
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Sample size
Target
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Accrual to date
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Final
208
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Site Reference 0360017 - Herston
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Recruitment hospital [2]
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Site reference 0360011 - Fitzroy
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Recruitment hospital [3]
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0
Site reference 0360008 - Southport
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Recruitment postcode(s) [1]
0
0
4029 - Herston
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Recruitment postcode(s) [2]
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0
- Fitzroy
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Recruitment postcode(s) [3]
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- Southport
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Colorado
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Country [5]
0
0
United States of America
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State/province [5]
0
0
District of Columbia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
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Indiana
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Country [9]
0
0
United States of America
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State/province [9]
0
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Kansas
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Country [10]
0
0
United States of America
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State/province [10]
0
0
New Jersey
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Country [11]
0
0
United States of America
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State/province [11]
0
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New York
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Country [12]
0
0
United States of America
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State/province [12]
0
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North Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
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Ohio
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Oklahoma
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Tennessee
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Country [16]
0
0
United States of America
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State/province [16]
0
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Texas
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Country [17]
0
0
United States of America
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State/province [17]
0
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Virginia
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Country [18]
0
0
United States of America
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State/province [18]
0
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Washington
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Country [19]
0
0
Belgium
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State/province [19]
0
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Leuven
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Country [20]
0
0
Canada
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State/province [20]
0
0
British Columbia
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Country [21]
0
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Canada
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State/province [21]
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Quebec
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Country [22]
0
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Canada
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State/province [22]
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Edmonton
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Country [23]
0
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Canada
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State/province [23]
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Toronto
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Country [24]
0
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Czechia
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State/province [24]
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Hradec Kralove
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Country [25]
0
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Czechia
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Prague
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Country [26]
0
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Estonia
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State/province [26]
0
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Tallinn
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Country [27]
0
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Finland
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State/province [27]
0
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Helsinki
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Country [28]
0
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France
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State/province [28]
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Clermont-Ferrand
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France
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Marseille
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France
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Nice
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France
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Pessac
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0
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Duesseldorf
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Germany
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Essen
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Germany
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Göttingen
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Germany
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Hannover
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Germany
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Ibbenbueren
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Germany
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Koeln
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Germany
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Leipzig
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Germany
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Potsdam
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Germany
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Wuerzburg
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Israel
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Haifa
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Israel
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Tel Aviv
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Italy
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Chieti
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Italy
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Firenze
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Italy
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Genova
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Italy
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Milano
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Torino
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Aomori
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Japan
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Chiba
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0
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Japan
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Kanagawa
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Japan
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Matsumoto
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Japan
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Osaka
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0
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Japan
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Saitama
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0
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Japan
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Tokushima
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0
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Japan
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Tokyo
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Japan
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Yamaguchi
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Netherlands
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Amsterdam
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Netherlands
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Maastricht
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Utrecht
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Poland
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Gdansk
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Poland
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Lodz
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Poland
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Lublin
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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United Kingdom
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London
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United Kingdom
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Manchester
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Funding & Sponsors
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Commercial sector/industry
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CSL Behring
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Commercial sector/industry
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ICON Clinical Research
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Ethics approval
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Summary
Brief summary
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP. Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo. The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.
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Trial website
https://clinicaltrials.gov/study/NCT01545076
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Trial related presentations / publications
van Schaik IN, Bril V, van Geloven N, Hartung HP, Lewis RA, Sobue G, Lawo JP, Praus M, Mielke O, Durn BL, Cornblath DR, Merkies ISJ; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018 Jan;17(1):35-46. doi: 10.1016/S1474-4422(17)30378-2. Epub 2017 Nov 6. Erratum In: Lancet Neurol. 2018 Jan;17(1):26. doi: 10.1016/S1474-4422(17)30427-1. Lancet Neurol. 2018 Aug;17(8):661. doi: 10.1016/S1474-4422(18)30260-6. van Schaik IN, van Geloven N, Bril V, Hartung HP, Lewis RA, Sobue G, Lawo JP, Mielke O, Cornblath DR, Merkies IS; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial. Trials. 2016 Jul 25;17(1):345. doi: 10.1186/s13063-016-1466-2.
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Public notes
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Contacts
Principal investigator
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Prof. Dr. Ivo N. van Schaik
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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What supporting documents are/will be available?
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT01545076
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