Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Conditions
- Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingChronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Interventions
- Biological: IgPro20
- Registration Number
- NCT02027701
- Lead Sponsor
- CSL Behring
- 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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IgPro20 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.
- Primary Outcome Measures
Name Time Method Number of Adverse Events (AEs) Per Infusion Up to 49 weeks
- Secondary Outcome Measures
Name Time Method Number of AEs by Severity Per Infusion Up to 49 weeks Percentage of Subjects With AEs by Severity Up to 49 weeks Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score Baseline and up to 49 weeks 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.
Percentage of Subjects With Serious AEs Up to 49 weeks Number of Serious AEs Per Infusion Up to 49 weeks Percentage of Subjects With Causally Related AEs Up to 49 weeks Time to First CIDP Relapse Up to 49 weeks 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).
Change From Baseline in Medical Research Council (MRC) Score Baseline and up to 49 weeks 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.
Change From Baseline in Rasch-built Overall Disability Scale (R-ODS) Baseline and up to 49 weeks 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.
Change From Baseline in Mean Grip Strength Baseline and up to 49 weeks 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.
Number of Causally Related AEs Per Infusion Up to 49 weeks Percentage of Subjects With Adverse Events (AEs) Up to 49 weeks
Trial Locations
- Locations (33)
Site Reference 8400166
🇺🇸Kansas City, Kansas, United States
Site Reference 8400182
🇺🇸Charlotte, North Carolina, United States
Site Reference 8400181
🇺🇸Birmingham, Alabama, United States
Site Reference 8400169
🇺🇸New York, New York, United States
Site Reference 8400167
🇺🇸Los Angeles, California, United States
Site Reference 0360017
🇦🇺Woolloongabba, Queensland, Australia
Site Reference 1240009
🇨🇦Toronto, Ontario, Canada
Site Reference 2030009
🇨🇿Hradec Kralove, Czechia
Site Reference 2030002
🇨🇿Hradec Kralove, Czechia
Site Reference 2500022
🇫🇷Nice Cedex 1, France
Site Reference 2760052
🇩🇪Essen, Nordrhein-Westfalen, Germany
Site Reference 2760049
🇩🇪Bochum, Germany
Site Reference 2760069
🇩🇪Berlin, Germany
Site Reference 2760072
🇩🇪Berlin, Germany
Site Reference 2760094
🇩🇪Essen, Germany
Site Reference 2760054
🇩🇪Hannover, Germany
Site Reference 2760055
🇩🇪Leipzig, Germany
Site Reference 2760039
🇩🇪Wurzburg, Germany
Site Reference 2760047
🇩🇪Potsdam, Germany
Site Reference 7240011
🇪🇸Barcelona, Spain
Site Reference 7240010
🇪🇸Barcelona, Spain
Site Reference 8260032
🇬🇧Salford, United Kingdom
Site Reference 8260019
🇬🇧London, United Kingdom
Site Reference 3920037
🇯🇵Tokorozawa, Saitama, Japan
Site Reference 3920061
🇯🇵Kanagawa, Japan
Site Reference 3920065
🇯🇵Tokyo, Japan
Site Reference 0360011
🇦🇺Fitzroy, Victoria, Australia
Site Reference 1240007
🇨🇦Greenfield Park, Quebec, Canada
Site Reference 3920035
🇯🇵Ube, Yamaguchi, Japan
Site Reference 3920038
🇯🇵Chiba, Japan
Site Reference 3920040
🇯🇵Nagoya, Japan
Site Reference 5280001
🇳🇱Amsterdam, Netherlands
Site Reference 3800031
🇮🇹Milano, Italy