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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004157-24 | EudraCT Number |
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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 If subjects do not successfully recover from CIDP relapse within 4 weeks, they will be withdrawn.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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgPro20 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgPro20 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AEs) Per Infusion | Up to 49 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First CIDP Relapse | 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). | Up to 49 weeks |
| Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Ivo N. van Schaik | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference 8400181 | Birmingham | Alabama | 35294-0017 | United States | ||
| Site Reference 8400167 |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | IgPro20 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 8, 2015 | Jul 9, 2018 |
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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. |
| Baseline and up to 49 weeks |
| Change From Baseline in Medical Research Council (MRC) Score | 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. | Baseline and up to 49 weeks |
| Change From Baseline in Rasch-built Overall Disability Scale (R-ODS) | 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. | Baseline and up to 49 weeks |
| Change From Baseline in Mean Grip Strength | 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. | Baseline and up to 49 weeks |
| Percentage of Subjects With Adverse Events (AEs) | Up to 49 weeks |
| Number of AEs by Severity Per Infusion | Up to 49 weeks |
| Percentage of Subjects With AEs by Severity | Up to 49 weeks |
| Number of Causally Related AEs Per Infusion | Up to 49 weeks |
| Percentage of Subjects With Causally Related AEs | Up to 49 weeks |
| Number of Serious AEs Per Infusion | Up to 49 weeks |
| Percentage of Subjects With Serious AEs | Up to 49 weeks |
| Los Angeles |
| California |
| 90033 |
| United States |
| Site Reference 8400166 | Kansas City | Kansas | 66160 | United States |
| Site Reference 8400169 | New York | New York | 10021 | United States |
| Site Reference 8400182 | Charlotte | North Carolina | 28210 | United States |
| Site Reference 0360017 | Woolloongabba | Queensland | 4102 | Australia |
| Site Reference 0360011 | Fitzroy | Victoria | 3065 | Australia |
| Site Reference 1240009 | Toronto | Ontario | M5G 2C4 | Canada |
| Site Reference 1240007 | Greenfield Park | Quebec | J4V2J2 | Canada |
| Site Reference 2030009 | Hradec Králové | 50003 | Czechia |
| Site Reference 2030002 | Hradec Králové | 50005 | Czechia |
| Site Reference 2500022 | Nice | 06002 | France |
| Site Reference 2760052 | Essen | North Rhine-Westphalia | 45117 | Germany |
| Site Reference 2760069 | Berlin | 10117 | Germany |
| Site Reference 2760072 | Berlin | 12200 | Germany |
| Site Reference 2760049 | Bochum | 44791 | Germany |
| Site Reference 2760094 | Essen | 45147 | Germany |
| Site Reference 2760054 | Hanover | 30625 | Germany |
| Site Reference 2760055 | Leipzig | DE04103 | Germany |
| Site Reference 2760047 | Potsdam | 14471 | Germany |
| Site Reference 2760039 | Würzburg | 97080 | Germany |
| Site Reference 3800031 | Milan | 20133 | Italy |
| Site Reference 3920037 | Tokorozawa | Saitama | 359-8513 | Japan |
| Site Reference 3920035 | Ube | Yamaguchi | 755-8505 | Japan |
| Site Reference 3920038 | Chiba | 260-8677 | Japan |
| Site Reference 3920061 | Kanagawa | 228-8555 | Japan |
| Site Reference 3920040 | Nagoya | 466-8560 | Japan |
| Site Reference 3920065 | Tokyo | 113-8431 | Japan |
| Site Reference 5280001 | Amsterdam | 1105 | Netherlands |
| Site Reference 7240011 | Barcelona | 08035 | Spain |
| Site Reference 7240010 | Barcelona | 08907 | Spain |
| Site Reference 8260019 | London | WC1N 3BG | United Kingdom |
| Site Reference 8260032 | Salford | M6 8HD | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | IgPro20 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events (AEs) Per Infusion | Safety Data Set (SDS): all subjects who received at least 1 dose of IgPro20 in this study. | Posted | Number | Adverse events per infusion | Up to 49 weeks | Infusions | Infusions |
|
|
| |||||||||||||||||||||||||||
| Secondary | Time to First CIDP Relapse | 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). | 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. | Posted | Median | 95% Confidence Interval | Days | Up to 49 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) 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. | Total Set | Posted | Median | Full Range | units on a scale | Baseline and up to 49 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Medical Research Council (MRC) Score | 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. | Total Set | Posted | Median | Full Range | units on a scale | Baseline and up to 49 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Rasch-built Overall Disability Scale (R-ODS) | 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. | Total Set | Posted | Median | Full Range | units on a scale | Baseline and up to 49 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Grip Strength | 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. | Total Set | Posted | Median | Full Range | kPa | Baseline and up to 49 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Adverse Events (AEs) | SDS | Posted | Number | percentage of subjects | Up to 49 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of AEs by Severity Per Infusion | SDS | Posted | Number | Adverse events per infusion | Up to 49 weeks | Infusions | Infusions |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With AEs by Severity | SDS | Posted | Number | percentage of subjects | Up to 49 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Causally Related AEs Per Infusion | SDS | Posted | Number | Adverse events per infusion | Up to 49 weeks | Infusions | Infusions |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Causally Related AEs | SDS | Posted | Number | percentage of subjects | Up to 49 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Serious AEs Per Infusion | SDS | Posted | Number | Adverse events per infusion | Up to 49 weeks | Infusions | Infusions |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Serious AEs | SDS | Posted | Number | percentage of subjects | Up to 49 weeks |
|
|
|
Up to 49 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IgPro20 | 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. | 0 | 82 | 7 | 82 | 25 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gallbladder Perforation | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Nerve Compression | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Pulmonary Sepsis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Urinary Tract Infection | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Chronic Inflammatory Demyelinating Polyradiculoneuropathy | Immune system disorders | MedDRA (14.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment | Worsening of upper back pain secondary to fall. Non-treatment emergent SAE, occurring before first dose of IgPro20. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site swelling | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Infusion site erythema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment | General disorders and administration site conditions |
|
| Infusion site swelling | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment | Local reactions |
|
| Infusion Site erythema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment | Local reactions |
|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | CSL Behring | Use email contact | clinicaltrials@cslbehring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2017 | Jul 9, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C558471 | Hizentra |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Czechia |
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| Japan |
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| Italy |
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| United Kingdom |
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| Australia |
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| France |
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| Germany |
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| Spain |
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| Mild |
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| Moderate |
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| Severe |
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