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Trial record 9 of 49 for:    CIDP

Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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ClinicalTrials.gov Identifier: NCT02027701
Recruitment Status : Completed
First Posted : January 6, 2014
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Intervention Biological: IgPro20
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IgPro20
Hide Arm/Group Description 20% liquid formulation (200 mg/mL) of human normal immunoglobulin administered SC weekly at 0.2 g/kg, and subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20.
Period Title: Overall Study
Started 82
Completed 66
Not Completed 16
Reason Not Completed
Adverse Event             3
Lack of Efficacy             8
Physician Decision             2
Withdrawal by Subject             3
Arm/Group Title IgPro20
Hide Arm/Group Description 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg.
Overall Number of Baseline Participants 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
<=18 years
0
   0.0%
Between 18 and 65 years
55
  67.1%
>=65 years
27
  32.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 82 participants
57.57  (13.224)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
Female
32
  39.0%
Male
50
  61.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
Hispanic or Latino
14
  17.1%
Not Hispanic or Latino
66
  80.5%
Unknown or Not Reported
2
   2.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants
American Indian or Alaska Native
1
   1.2%
Asian
10
  12.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
70
  85.4%
More than one race
0
   0.0%
Unknown or Not Reported
1
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants
Canada 7
Netherlands 1
United States 9
Czechia 2
Japan 10
Italy 8
United Kingdom 4
Australia 1
France 1
Germany 29
Spain 10
1.Primary Outcome
Title Number of Adverse Events (AEs) Per Infusion
Hide Description [Not Specified]
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Data Set (SDS): all subjects who received at least 1 dose of IgPro20 in this study.
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
5553
Measure Type: Number
Unit of Measure: Adverse events per infusion
0.032
2.Secondary Outcome
Title Time to First CIDP Relapse
Hide Description Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. 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 only).
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total Set: all subjects enrolled in the study, ie, the subject’s informed consent was obtained. In the study protocol, this analysis set was referred to as the Intention-to-Treat Data Set.
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Median (95% Confidence Interval)
Unit of Measure: Days
266.0 [1] 
(225.0 to NA)
[1]
The upper limit of the 95% confidence interval for the median time to relapse cannot be estimated, because the curve representing the upper confidence limit lies above 0.5.
3.Secondary Outcome
Title Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
Hide 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 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total Set
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 80
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-3 to 6)
4.Secondary Outcome
Title Change From Baseline in Medical Research Council (MRC) Score
Hide Description An adapted version of the MRC sum score as published by Kleyweg and the RMC trial group was used. With the MRC sum score, the following 8 bilateral muscle pairs were assessed, and individual muscle scores as well as the sum score documented: Shoulder abduction; Elbow flexion; Wrist extension; Index finger abduction; Hip flexion; Knee extension; Foot dorsiflexion; Great toe dorsiflexion. The MRC sum score ranges from 0 (paralysis) to 80 (normal strength) points.
Time Frame Baseline and up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total Set
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 78
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-23 to 18)
5.Secondary Outcome
Title Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)
Hide Description The R-ODS is a recently published outcome measure that captures activity and social participation in subjects with Guillain-Barré Syndrome, CIDP, and monoclonal gammopathy of uncertain significance. The 24-item questionnaire covers a wide range of tasks of daily life that are each to be rated as “impossible to perform”, “able to perform with difficulty”, or “easy to perform” (scale of 0 - 2 points respectively). Items are sorted in order of increasing difficulty to perform, based on data from subjects with peripheral neuropathies (chronic inflammatory demyelinating polyneuropathy, Guillain-Barré Syndrome, or monoclonal gammopathy of uncertain significance) and subjects recruited at the university outpatient clinics of Rotterdam and Maastricht.
Time Frame Baseline and up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total Set
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 71
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-76 to 33)
6.Secondary Outcome
Title Change From Baseline in Mean Grip Strength
Hide Description The hand-held Vigorimeter from Martin (Tuttlingen, Germany) is a device that measures the strength of small muscles in the hand, ie, grip strength. The subject squeezes a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure is recorded via a rubber tube on a nanometer and expressed in kilopascal (kPa). At each assessment, the subject squeezes 3 times with each hand.
Time Frame Baseline and up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total Set
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 79
Median (Full Range)
Unit of Measure: kPa
-0.7
(-80 to 27)
7.Secondary Outcome
Title Percentage of Subjects With Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: percentage of subjects
75.6
8.Secondary Outcome
Title Number of AEs by Severity Per Infusion
Hide Description [Not Specified]
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
5553
Measure Type: Number
Unit of Measure: Adverse events per infusion
Mild 0.024
Moderate 0.006
Severe 0.002
9.Secondary Outcome
Title Percentage of Subjects With AEs by Severity
Hide Description [Not Specified]
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: percentage of subjects
Mild 62.2
Moderate 29.3
Severe 9.8
10.Secondary Outcome
Title Number of Causally Related AEs Per Infusion
Hide Description [Not Specified]
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
5553
Measure Type: Number
Unit of Measure: Adverse events per infusion
0.011
11.Secondary Outcome
Title Percentage of Subjects With Causally Related AEs
Hide Description [Not Specified]
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: percentage of subjects
25.6
12.Secondary Outcome
Title Number of Serious AEs Per Infusion
Hide Description [Not Specified]
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
5553
Measure Type: Number
Unit of Measure: Adverse events per infusion
0.001
13.Secondary Outcome
Title Percentage of Subjects With Serious AEs
Hide Description [Not Specified]
Time Frame Up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
SDS
Arm/Group Title IgPro20
Hide Arm/Group Description:
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: percentage of subjects
8.5
Time Frame Up to 49 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IgPro20
Hide Arm/Group Description 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly at 0.2 g/kg or 0.4 g/kg for up to 49 weeks.
All-Cause Mortality
IgPro20
Affected / at Risk (%)
Total   0/82 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
IgPro20
Affected / at Risk (%) # Events
Total   7/82 (8.54%)    
Cardiac disorders   
Atrial Flutter  1  2/82 (2.44%)  2
Gastrointestinal disorders   
Faecaloma  1  1/82 (1.22%)  1
Hepatobiliary disorders   
Gallbladder Perforation  1  1/82 (1.22%)  1
Immune system disorders   
Chronic Inflammatory Demyelinating Polyradiculoneuropathy  1  1/82 (1.22%)  1
Musculoskeletal and connective tissue disorders   
Back Pain  1 [1]  1/82 (1.22%)  1
Nervous system disorders   
Nerve Compression  1  1/82 (1.22%)  1
Renal and urinary disorders   
Urinary Tract Infection  1  1/82 (1.22%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary Sepsis  1  1/82 (1.22%)  1
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
[1]
Worsening of upper back pain secondary to fall. Non-treatment emergent SAE, occurring before first dose of IgPro20.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IgPro20
Affected / at Risk (%) # Events
Total   25/82 (30.49%)    
Infections and infestations   
Nasopharyngitis  1  11/82 (13.41%)  13
Nervous system disorders   
Headache  1  4/82 (4.88%)  5
Skin and subcutaneous tissue disorders   
Infusion site swelling  1 [1]  9/82 (10.98%)  11
Infusion site erythema  1 [1]  7/82 (8.54%)  9
Infusion site swelling  1 [2]  9/82 (10.98%)  11
Infusion Site erythema  1 [2]  7/82 (8.54%)  9
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
[1]
General disorders and administration site conditions
[2]
Local reactions
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
CSL agreements may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
Phone: Use email contact
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT02027701     History of Changes
Other Study ID Numbers: IgPro20_3004
2013-004157-24 ( EudraCT Number )
First Submitted: January 3, 2014
First Posted: January 6, 2014
Results First Submitted: July 9, 2018
Results First Posted: October 2, 2018
Last Update Posted: October 2, 2018