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
Interventional
Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biological: IgPro20
82
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Arm/Group Title
IgPro20
Arm/Group Description
20% liquid formulation (200 mg/mL) ...
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
Baseline Analysis Population Description
[Not Specified]
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
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1.Primary Outcome
2.Secondary Outcome
Title
Time to First CIDP Relapse
Description
Time to first CIDP relapse based on adjusted INCAT score, using the Ka...
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
Analysis Population Description
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
Arm/Group Description
20% liquid formulation (200 mg/mL) ...
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
(225.0 to NA)
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
Description
The INCAT score is a 10-point scale that covers the functionality of l...
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
Analysis Population Description
Analysis Population Description
Total Set
Arm/Group Title
IgPro20
Arm/Group Description
20% liquid formulation (200 mg/mL) ...
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
Description
An adapted version of the MRC sum score as published by Kleyweg and th...
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
Analysis Population Description
Analysis Population Description
Total Set
Arm/Group Title
IgPro20
Arm/Group Description
20% liquid formulation (200 mg/mL) ...
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)
Description
The R-ODS is a recently published outcome measure that captures activi...
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
Analysis Population Description
Analysis Population Description
Total Set
Arm/Group Title
IgPro20
Arm/Group Description
20% liquid formulation (200 mg/mL) ...
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
Description
The hand-held Vigorimeter from Martin (Tuttlingen, Germany) is a devic...
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
Analysis Population Description
Analysis Population Description
Total Set
Arm/Group Title
IgPro20
Arm/Group Description
20% liquid formulation (200 mg/mL) ...
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
8.Secondary Outcome
9.Secondary Outcome
10.Secondary Outcome
11.Secondary Outcome
12.Secondary Outcome
13.Secondary Outcome
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Time Frame
Up to 49 weeks
Adverse Event Reporting Description
[Not Specified]
Arm/Group Title
IgPro20
Arm/Group Description
20% liquid formulation (200 mg/mL) ...
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.
IgPro20
Affected / at Risk (%)
Total
0/82 (0.00%)
IgPro20
Affected / at Risk (%)
# Events
Total
7/82 (8.54%)
Cardiac disorders
Atrial Flutter
2/82 (2.44%)
2
Gastrointestinal disorders
Faecaloma
1/82 (1.22%)
1
Hepatobiliary disorders
Gallbladder Perforation
1/82 (1.22%)
1
Immune system disorders
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
1/82 (1.22%)
1
Musculoskeletal and connective tissue disorders
Back Pain
1/82 (1.22%)
1
Nervous system disorders
Nerve Compression
1/82 (1.22%)
1
Renal and urinary disorders
Urinary Tract Infection
1/82 (1.22%)
1
Respiratory, thoracic and mediastinal disorders
Pulmonary Sepsis
1/82 (1.22%)
1
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
Worsening of upper back pain secondary to fall. Non-treatment emergent SAE, occurring before first dose of IgPro20.
Frequency Threshold for Reporting Other Adverse Events
5%
IgPro20
Affected / at Risk (%)
# Events
Total
25/82 (30.49%)
Infections and infestations
Nasopharyngitis
11/82 (13.41%)
13
Nervous system disorders
Headache
4/82 (4.88%)
5
Skin and subcutaneous tissue disorders
Infusion site swelling
9/82 (10.98%)
11
Infusion site erythema
7/82 (8.54%)
9
Infusion site swelling
9/82 (10.98%)
11
Infusion Site erythema
7/82 (8.54%)
9
Term from vocabulary, MedDRA (14.1)
Indicates events were collected by systematic assessment
General disorders and administration site conditions
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[Not Specified]
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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.
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
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
