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Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

Primary Purpose

Chronic Inflammatory Demyelinating Polyneuropathy, Polyradiculoneuropathy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IgPro20 (low dose)
Placebo
IgPro10
IgPro20 (high dose)
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Sites / Locations

  • Site reference 8400181
  • Site reference 8400173
  • Site reference 8400172
  • Site reference 8400167
  • Site reference 8400077
  • Site Reference 8400352
  • Site reference 8400214
  • Site reference 8400162
  • Site Reference 8400247
  • Site Reference 8400215
  • Site reference 8400166
  • Site Reference 8400347
  • Site reference 8400169
  • Site reference 8400179
  • Site reference 8400182
  • Site Reference 8400346
  • Site reference 8400178
  • Site reference 8400217
  • Site Reference 8400177
  • Site reference 8400164
  • Site Reference 8400268
  • Site Reference 8400340
  • Site Reference 0360017
  • Site reference 0360011
  • Site reference 0360008
  • Site reference 0560003
  • Site Reference 1240048
  • Site Reference 1240051
  • Site reference 1240006
  • Site reference 1240007
  • Site reference 1240009
  • Site reference 2030002
  • Site reference 2030009
  • Site reference 2030003
  • Site Reference 2330002
  • Site Reference 2330003
  • Site reference 2460002
  • Site reference 2500024
  • Site reference 2500013
  • Site reference 2500022
  • Site reference 2500019
  • Site reference 2760048
  • Site reference 2760069
  • Site reference 2760072
  • Site reference 2760049
  • Site reference 2760075
  • Site Reference 2760094
  • Site reference 2760052
  • Site reference 2760036
  • Site reference 2760053
  • Site reference 2760054
  • Site Reference 2760113
  • Site reference 2760080
  • Site reference 2760055
  • Site reference 2760047
  • Site reference 2760039
  • Site reference 3760005
  • Site reference 3760002
  • Site reference 3800026
  • Site reference 3800027
  • Site reference 3800028
  • Site reference 3800031
  • Site reference 3800035
  • Site reference 3800036
  • Site reference 3800030
  • Site reference 3800037
  • Site Reference 3920040
  • Site Reference 3920042
  • Site reference 3920038
  • Site reference 3920061
  • Site reference 3920045
  • Site reference 3920058
  • Site reference 3920037
  • Site reference 3920034
  • Site Reference 3920065
  • Site Reference 3920062
  • Site reference 3920032
  • Site reference 3920035
  • Site reference 5280001
  • Site reference 5280005
  • Site reference 5280004
  • Site Reference 6160058
  • Site Reference 6160060
  • Site Reference 6160055
  • Site reference 7240010
  • Site reference 7240011
  • Site reference 7240013
  • Site reference 7240014
  • Site reference 7240016
  • Site reference 8260019
  • Site Reference 8260032

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

IgPro20 low dose

IgPro20 high dose

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
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.

Secondary Outcome Measures

Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
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.
Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
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.
Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
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).
Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
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).
Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
Number of Subjects With Adverse Events During the SC Treatment Period
Percentage of Subjects With Adverse Events During the SC Treatment Period
Time to Improvement During IgPro10 Re-stabilization Therapy
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.
Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
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.
Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
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).
Change in R-ODS During IgPro10 Re-stabilization Therapy
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).
Change in INCAT During IgPro10 Re-stabilization Therapy
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.
Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
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.
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
Change in Mean Grip Strength During IgPro10 Rescue Therapy
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.
Change in MRC Sum Score During IgPro10 Rescue Therapy
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).
Change in R-ODS During IgPro10 Rescue Therapy
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).
Change in INCAT During IgPro10 Rescue Therapy
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.

Full Information

First Posted
March 1, 2012
Last Updated
July 3, 2018
Sponsor
CSL Behring
Collaborators
ICON Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT01545076
Brief Title
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
Collaborators
ICON Clinical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Demyelinating Polyneuropathy, Polyradiculoneuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IgPro20 low dose
Arm Type
Experimental
Arm Title
IgPro20 high dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
IgPro20 (low dose)
Other Intervention Name(s)
Hizentra
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Intervention Type
Biological
Intervention Name(s)
IgPro10
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
IgPro20 (high dose)
Other Intervention Name(s)
Hizentra
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
Description
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.
Time Frame
Up to 25 weeks
Secondary Outcome Measure Information:
Title
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
Description
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.
Time Frame
Baseline and up to 25 weeks
Title
Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
Description
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.
Time Frame
Baseline and up to 25 weeks
Title
Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
Description
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).
Time Frame
Baseline and up to 25 weeks
Title
Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
Description
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).
Time Frame
Baseline and up to 25 weeks
Title
Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
Time Frame
Up to 25 weeks
Title
Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
Time Frame
Up to 28 weeks
Title
Number of Subjects With Adverse Events During the SC Treatment Period
Time Frame
Up to 28 weeks
Title
Percentage of Subjects With Adverse Events During the SC Treatment Period
Time Frame
Up to 28 weeks
Title
Time to Improvement During IgPro10 Re-stabilization Therapy
Description
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.
Time Frame
Up to 13 weeks
Title
Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
Description
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.
Time Frame
Reference visit and up to 13 weeks
Title
Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
Description
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).
Time Frame
Reference visit and up to 13 weeks
Title
Change in R-ODS During IgPro10 Re-stabilization Therapy
Description
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).
Time Frame
Reference visit and up to 13 weeks
Title
Change in INCAT During IgPro10 Re-stabilization Therapy
Description
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.
Time Frame
Reference visit and up to 13 weeks
Title
Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
Time Frame
Up to 13 weeks
Title
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time Frame
Up to 13 weeks
Title
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time Frame
Up to 13 weeks
Title
Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
Description
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.
Time Frame
Up to 13 weeks
Title
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
Time Frame
Up to 13 weeks
Title
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
Time Frame
Up to 13 weeks
Title
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
Time Frame
Up to 13 weeks
Title
Change in Mean Grip Strength During IgPro10 Rescue Therapy
Description
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.
Time Frame
Before first rescue IgPro10 infusion and up to 13 weeks
Title
Change in MRC Sum Score During IgPro10 Rescue Therapy
Description
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).
Time Frame
Before first rescue IgPro10 infusion and up to 13 weeks
Title
Change in R-ODS During IgPro10 Rescue Therapy
Description
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).
Time Frame
Before first rescue IgPro10 infusion and up to 13 weeks
Title
Change in INCAT During IgPro10 Rescue Therapy
Description
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.
Time Frame
Before first rescue IgPro10 infusion and up to 13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Ivo N. van Schaik
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site reference 8400181
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Site reference 8400173
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Site reference 8400172
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Site reference 8400167
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Site reference 8400077
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Site Reference 8400352
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Site reference 8400214
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site reference 8400162
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Site Reference 8400247
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Site Reference 8400215
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Site reference 8400166
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Site Reference 8400347
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Site reference 8400169
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Site reference 8400179
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Site reference 8400182
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Site Reference 8400346
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Site reference 8400178
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Site reference 8400217
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Site Reference 8400177
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Site reference 8400164
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Site Reference 8400268
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Site Reference 8400340
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Site Reference 0360017
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Site reference 0360011
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
Site reference 0360008
City
Southport
Country
Australia
Facility Name
Site reference 0560003
City
Leuven
Country
Belgium
Facility Name
Site Reference 1240048
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Site Reference 1240051
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Site reference 1240006
City
Edmonton
Country
Canada
Facility Name
Site reference 1240007
City
Quebec
Country
Canada
Facility Name
Site reference 1240009
City
Toronto
Country
Canada
Facility Name
Site reference 2030002
City
Hradec Kralove
Country
Czechia
Facility Name
Site reference 2030009
City
Hradec Kralove
Country
Czechia
Facility Name
Site reference 2030003
City
Prague
Country
Czechia
Facility Name
Site Reference 2330002
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Site Reference 2330003
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Site reference 2460002
City
Helsinki
Country
Finland
Facility Name
Site reference 2500024
City
Clermont-Ferrand
Country
France
Facility Name
Site reference 2500013
City
Marseille
Country
France
Facility Name
Site reference 2500022
City
Nice
Country
France
Facility Name
Site reference 2500019
City
Pessac
Country
France
Facility Name
Site reference 2760048
City
Berlin
Country
Germany
Facility Name
Site reference 2760069
City
Berlin
Country
Germany
Facility Name
Site reference 2760072
City
Berlin
Country
Germany
Facility Name
Site reference 2760049
City
Bochum
Country
Germany
Facility Name
Site reference 2760075
City
Duesseldorf
Country
Germany
Facility Name
Site Reference 2760094
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Site reference 2760052
City
Essen
Country
Germany
Facility Name
Site reference 2760036
City
Göttingen
Country
Germany
Facility Name
Site reference 2760053
City
Göttingen
Country
Germany
Facility Name
Site reference 2760054
City
Hannover
Country
Germany
Facility Name
Site Reference 2760113
City
Ibbenbueren
ZIP/Postal Code
49477
Country
Germany
Facility Name
Site reference 2760080
City
Koeln
Country
Germany
Facility Name
Site reference 2760055
City
Leipzig
Country
Germany
Facility Name
Site reference 2760047
City
Potsdam
Country
Germany
Facility Name
Site reference 2760039
City
Wuerzburg
Country
Germany
Facility Name
Site reference 3760005
City
Haifa
Country
Israel
Facility Name
Site reference 3760002
City
Tel Aviv
Country
Israel
Facility Name
Site reference 3800026
City
Chieti
Country
Italy
Facility Name
Site reference 3800027
City
Firenze
Country
Italy
Facility Name
Site reference 3800028
City
Genova
Country
Italy
Facility Name
Site reference 3800031
City
Milano
Country
Italy
Facility Name
Site reference 3800035
City
Roma
Country
Italy
Facility Name
Site reference 3800036
City
Roma
Country
Italy
Facility Name
Site reference 3800030
City
Rozzano
Country
Italy
Facility Name
Site reference 3800037
City
Torino
Country
Italy
Facility Name
Site Reference 3920040
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Site Reference 3920042
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Site reference 3920038
City
Chiba
Country
Japan
Facility Name
Site reference 3920061
City
Kanagawa
Country
Japan
Facility Name
Site reference 3920045
City
Matsumoto
Country
Japan
Facility Name
Site reference 3920058
City
Osaka
Country
Japan
Facility Name
Site reference 3920037
City
Saitama
Country
Japan
Facility Name
Site reference 3920034
City
Tokushima
Country
Japan
Facility Name
Site Reference 3920065
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Site Reference 3920062
City
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Site reference 3920032
City
Tokyo
Country
Japan
Facility Name
Site reference 3920035
City
Yamaguchi
Country
Japan
Facility Name
Site reference 5280001
City
Amsterdam
Country
Netherlands
Facility Name
Site reference 5280005
City
Maastricht
Country
Netherlands
Facility Name
Site reference 5280004
City
Utrecht
Country
Netherlands
Facility Name
Site Reference 6160058
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
Site Reference 6160060
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Site Reference 6160055
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Site reference 7240010
City
Barcelona
Country
Spain
Facility Name
Site reference 7240011
City
Barcelona
Country
Spain
Facility Name
Site reference 7240013
City
Madrid
Country
Spain
Facility Name
Site reference 7240014
City
Madrid
Country
Spain
Facility Name
Site reference 7240016
City
Sevilla
Country
Spain
Facility Name
Site reference 8260019
City
London
Country
United Kingdom
Facility Name
Site Reference 8260032
City
Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29122523
Citation
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. Lancet Neurol. 2018 Aug;17(8):661.
Results Reference
derived
PubMed Identifier
27455854
Citation
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.
Results Reference
derived

Learn more about this trial

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

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