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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02027701
Registration number
NCT02027701
Ethics application status
Date submitted
3/01/2014
Date registered
6/01/2014
Date last updated
2/10/2018
Titles & IDs
Public title
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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Scientific title
Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of IgPro20 in Maintenance Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Subjects Completing Study IgPro20_3003
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Secondary ID [1]
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2013-004157-24
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Secondary ID [2]
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IgPro20_3004
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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 (CIDP)
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
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Condition category
Condition code
Neurological
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Other neurological disorders
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Inflammatory and Immune System
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Autoimmune diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Neurological
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Neurodegenerative diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - IgPro20
Experimental: IgPro20 - 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for SC use administered SC weekly: 0.2 g/kg bw (low-dose IgPro20) for up to 48 weeks. Subjects who experience CIDP relapse on 0.2 g/kg IgPro20 will have an increase to 0.4 g/kg IgPro20 immediately and will continue on high-dose until they have completed a total of 48 weeks of IgPro20 treatment.
Other interventions: IgPro20
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Intervention code [1]
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Other interventions
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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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Number of Adverse Events (AEs) Per Infusion
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Assessment method [1]
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Timepoint [1]
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Up to 49 weeks
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Secondary outcome [1]
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Time to First CIDP Relapse
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Assessment method [1]
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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).
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Timepoint [1]
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Up to 49 weeks
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Secondary outcome [2]
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Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score
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Assessment method [2]
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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 [2]
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Baseline and up to 49 weeks
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Secondary outcome [3]
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Change From Baseline in Medical Research Council (MRC) Score
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and up to 49 weeks
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Secondary outcome [4]
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Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and up to 49 weeks
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Secondary outcome [5]
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Change From Baseline in Mean Grip Strength
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and up to 49 weeks
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Secondary outcome [6]
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Percentage of Subjects With Adverse Events (AEs)
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Assessment method [6]
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Timepoint [6]
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Up to 49 weeks
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Secondary outcome [7]
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Number of AEs by Severity Per Infusion
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Assessment method [7]
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Timepoint [7]
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Up to 49 weeks
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Secondary outcome [8]
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Percentage of Subjects With AEs by Severity
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Assessment method [8]
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Timepoint [8]
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Up to 49 weeks
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Secondary outcome [9]
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Number of Causally Related AEs Per Infusion
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Assessment method [9]
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Timepoint [9]
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Up to 49 weeks
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Secondary outcome [10]
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Percentage of Subjects With Causally Related AEs
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Assessment method [10]
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Timepoint [10]
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Up to 49 weeks
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Secondary outcome [11]
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Number of Serious AEs Per Infusion
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Assessment method [11]
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Timepoint [11]
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Up to 49 weeks
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Secondary outcome [12]
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Percentage of Subjects With Serious AEs
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Assessment method [12]
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Timepoint [12]
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Up to 49 weeks
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Eligibility
Key inclusion criteria
- Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully
rescued from a CIDP relapse during the SC Treatment Period of pivotal study
IgPro20_3003 (NCT01545076).
- 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
- Subject is unable to directly transition from study IgPro20_3003.
- New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse)
during participation in study IgPro20_3003 that in the judgment of the investigator
could increase risk to the subject, interfere with the evaluation of investigational
medicinal product, and/or conduct of the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
30/07/2014
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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
10/07/2017
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Sample size
Target
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Accrual to date
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Final
82
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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 - Woolloongabba
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Recruitment hospital [2]
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Site Reference 0360011 - Fitzroy
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Kansas
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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Canada
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State/province [6]
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Ontario
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Country [7]
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Canada
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State/province [7]
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Quebec
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Country [8]
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Czechia
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State/province [8]
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Hradec Kralove
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Country [9]
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France
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State/province [9]
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Nice Cedex 1
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Country [10]
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Germany
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State/province [10]
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Nordrhein-Westfalen
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Country [11]
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Germany
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State/province [11]
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Berlin
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Country [12]
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Germany
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State/province [12]
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Bochum
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Country [13]
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Germany
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State/province [13]
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Essen
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Country [14]
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Germany
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State/province [14]
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Hannover
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Country [15]
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Germany
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State/province [15]
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Leipzig
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Country [16]
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Germany
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State/province [16]
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Potsdam
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Country [17]
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Germany
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State/province [17]
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Wurzburg
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Country [18]
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Italy
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State/province [18]
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Milano
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Japan
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State/province [19]
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Saitama
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Japan
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State/province [20]
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Yamaguchi
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Country [21]
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Japan
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State/province [21]
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Chiba
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Country [22]
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Japan
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State/province [22]
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Kanagawa
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Country [23]
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Japan
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State/province [23]
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Nagoya
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Country [24]
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Japan
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State/province [24]
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Tokyo
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Country [25]
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Netherlands
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State/province [25]
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Amsterdam
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Country [26]
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Spain
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State/province [26]
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Barcelona
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Country [27]
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United Kingdom
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State/province [27]
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London
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Country [28]
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United Kingdom
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State/province [28]
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Salford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose
of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with
regard to safety and efficacy.
Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a
CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will
have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for
up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose
IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment.
Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed
a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP
relapse within 4 weeks, they will be withdrawn.
The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02027701
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof. Dr. Ivo N. van Schaik
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Address
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02027701
Download to PDF