A Phase 3 interventional study of IgPro20 (low dose) and Placebo in Chronic Inflammatory Demyelinating Polyneuropathy and Polyradiculoneuropathy, sponsored by CSL Behring. Completed at 91 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.
Sponsored by CSL Behring (part of CSL Limited) · Phase 3, Interventional, and Treatment
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with CIDP.
Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.
The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
This study's enrollment of 208 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
First submitted after CSL Behring became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: IgPro20 (low dose) · Biological: IgPro10
Biological: IgPro10 · Biological: IgPro20 (high dose)
Biological: Placebo · Biological: IgPro10
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization: 0.2 g/kg body weight (low dose arm)
Also known as: Hizentra
2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse.
20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization: 0.4 g/kg body weight (high dose arm)
Also known as: Hizentra
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
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). 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: Up to 25 weeks
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
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 25 weeks
Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
Time frame: Baseline and up to 25 weeks
Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
Time frame: Baseline and up to 25 weeks
Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
Time frame: Baseline and up to 25 weeks
Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
Time frame: Up to 25 weeks
Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
Time frame: Up to 28 weeks
Number of Subjects With Adverse Events During the SC Treatment Period
Time frame: Up to 28 weeks
Percentage of Subjects With Adverse Events During the SC Treatment Period
Time frame: Up to 28 weeks
Time to Improvement During IgPro10 Re-stabilization Therapy
Improvement is defined as an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, Mean Grip strength improvement by at least 8 kPa in one hand, or MRC Sum score \>=3.
Time frame: Up to 13 weeks
Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
Time frame: Reference visit and up to 13 weeks
Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
Time frame: Reference visit and up to 13 weeks
Change in R-ODS During IgPro10 Re-stabilization Therapy
The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
Time frame: Reference visit and up to 13 weeks
Change in INCAT During IgPro10 Re-stabilization Therapy
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: Reference visit and up to 13 weeks
Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
Time frame: Up to 13 weeks
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time frame: Up to 13 weeks
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time frame: Up to 13 weeks
Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline 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.
Time frame: Up to 13 weeks
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
Time frame: Up to 13 weeks
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
Time frame: Up to 13 weeks
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
Time frame: Up to 13 weeks
Change in Mean Grip Strength During IgPro10 Rescue Therapy
The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
Time frame: Before first rescue IgPro10 infusion and up to 13 weeks
Change in MRC Sum Score During IgPro10 Rescue Therapy
An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
Time frame: Before first rescue IgPro10 infusion and up to 13 weeks
Change in R-ODS During IgPro10 Rescue Therapy
The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
Time frame: Before first rescue IgPro10 infusion and up to 13 weeks
Change in INCAT During IgPro10 Rescue Therapy
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: Before first rescue IgPro10 infusion and up to 13 weeks
| Milestone | IgPro10 Re-stabilization | IgPro20 (0.4) | IgPro20 (0.2) | Placebo | IgPro10 Rescue |
|---|---|---|---|---|---|
| Started | 208 | 0 | 0 | 0 | 0 |
| Completed | 172 | 0 | 0 | 0 | 0 |
| Not completed | 36 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 4 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Failure to meet randomization criteria | 22 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 7 | 0 | 0 | 0 | 0 |
| Milestone | IgPro10 Re-stabilization | IgPro20 (0.4) | IgPro20 (0.2) | Placebo | IgPro10 Rescue |
|---|---|---|---|---|---|
| Started | 0 | 58 | 57 | 57 | 0 |
| Completed | 0 | 39 | 36 | 21 | 0 |
| Not completed | 0 | 19 | 21 | 36 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 10 | 18 | 32 | 0 |
| Withdrew: Adverse event | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 8 | 2 | 3 | 0 |
| Milestone | IgPro10 Re-stabilization | IgPro20 (0.4) | IgPro20 (0.2) | Placebo | IgPro10 Rescue |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 60 |
| Completed | 0 | 0 | 0 | 0 | 60 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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). 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 | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period | 32.8 | 38.6 | 63.2 |
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.
| units on a scale | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period | 0 (-2 to 3) | 0 (-2 to 5) | 1 (-1 to 4) |
The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
| Kilopascal (kPa) | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period | -2.7 (-80 to 55) | -0.6 (-80 to 55) | -6.6 (-51 to 22) |
An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
| units on a scale | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period | 0 (-12 to 7) | 0 (-16 to 14) | -2 (-19 to 6) |
The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
| units on a scale | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period | 0 (-49 to 17) | -2 (-41 to 100) | -3 (-43 to 13) |
| Days | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period | NA (NA to NA) | NA (113.0 to NA) | 79.0 (57.0 to 125.0) |
| Adverse events/Infusion | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period | 0.051 | 0.079 | 0.034 |
| Participants | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Number of Subjects With Adverse Events During the SC Treatment Period | 30 | 33 | 21 |
| percentage of subjects | IgPro20 (0.4) | IgPro20 (0.2) | Placebo |
|---|---|---|---|
| Percentage of Subjects With Adverse Events During the SC Treatment Period | 51.7 | 57.9 | 36.8 |
Improvement is defined as an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, Mean Grip strength improvement by at least 8 kPa in one hand, or MRC Sum score \>=3.
| Days | IgPro10 |
|---|---|
| Time to Improvement During IgPro10 Re-stabilization Therapy | 23 (22 to 23) |
The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
| kPa | IgPro10 |
|---|---|
| Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy | 11.27 ± 16.89 |
An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
| units on a scale | IgPro10 |
|---|---|
| Change in MRC Sum Score During IgPro10 Re-stabilization Therapy | 3.4 ± 4.9 |
The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
| units on a scale | IgPro10 |
|---|---|
| Change in R-ODS During IgPro10 Re-stabilization Therapy | 4.7 ± 14.14 |
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.
| units on a scale | IgPro10 |
|---|---|
| Change in INCAT During IgPro10 Re-stabilization Therapy | -1.1 ± 1.2 |
| Adverse events/Infusion | IgPro10 |
|---|---|
| Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy | 0.175 |
| participants | IgPro10 |
|---|---|
| Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy | 100 |
| percentage of subjects | IgPro10 |
|---|---|
| Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy | 48.3 |
Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline 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.
| Days | IgPro10 |
|---|---|
| Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy | 23 (22 to 49) |
| Adverse events/Infusion | IgPro10 |
|---|---|
| Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy | 0.142 |
| participants | IgPro10 |
|---|---|
| Number of Subjects With Adverse Events During IgPro10 Rescue Therapy | 17 |
| percentage of subjects | IgPro10 |
|---|---|
| Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy | 28.3 |
The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.
| kPa | IgPro10 |
|---|---|
| Change in Mean Grip Strength During IgPro10 Rescue Therapy | 16.3 ± 17.58 |
An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).
| units on a scale | IgPro10 |
|---|---|
| Change in MRC Sum Score During IgPro10 Rescue Therapy | 6.8 ± 5.28 |
The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).
| units on a scale | IgPro10 |
|---|---|
| Change in R-ODS During IgPro10 Rescue Therapy | 14.0 ± 14.69 |
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.
| units on a scale | IgPro10 |
|---|---|
| Change in INCAT During IgPro10 Rescue Therapy | -1.3 ± 1.31 |
Collected over 4.5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IgPro10 Restabilization | 0/207 (0%) | 11/207 (5.3%) | 50/207 (24.2%) |
| IgPro20 (0.4) | 0/58 (0%) | 2/58 (3.4%) | 20/58 (34.5%) |
| IgPro20 (0.2) | 0/57 (0%) | 3/57 (5.3%) | 22/57 (38.6%) |
| Placebo | 0/57 (0%) | 1/57 (1.8%) | 15/57 (26.3%) |
| IgPro10 Rescue | 0/60 (0%) | 2/60 (3.3%) | 7/60 (11.7%) |
| Event | IgPro10 Restabilization | IgPro20 (0.4) | IgPro20 (0.2) | Placebo | IgPro10 Rescue |
|---|---|---|---|---|---|
| Inguinal herniaGastrointestinal disorders | 0/207 | 0/58 | 0/57 | 1/57 | 0/60 |
| Dermatitis allergicSkin and subcutaneous tissue disorders | 0/207 | 0/58 | 1/57 | 0/57 | 0/60 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/207 | 0/58 | 1/57 | 0/57 | 0/60 |
| Fracture nonunionMusculoskeletal and connective tissue disorders | 0/207 | 0/58 | 1/57 | 0/57 | 0/60 |
| Bacterial infectionInfections and infestations | 0/207 | 0/58 | 1/57 | 0/57 | 0/60 |
| Device related infectionInfections and infestations | 0/207 | 0/58 | 1/57 | 0/57 | 0/60 |
| AnemiaBlood and lymphatic system disorders | 0/207 | 1/58 | 0/57 | 0/57 | 0/60 |
| Cholecystitis acuteHepatobiliary disorders | 0/207 | 1/58 | 0/57 | 0/57 | 0/60 |
| ArthropathyMusculoskeletal and connective tissue disorders | 0/207 | 1/58 | 0/57 | 0/57 | 0/60 |
| SepsisInfections and infestations | 0/207 | 1/58 | 0/57 | 0/57 | 0/60 |
| Event | IgPro10 Restabilization | IgPro20 (0.4) | IgPro20 (0.2) | Placebo | IgPro10 Rescue |
|---|---|---|---|---|---|
| Infusion site erythemaGeneral disorders | 0/207 | 10/58 | 5/57 | 0/57 | 0/60 |
| HeadacheNervous system disorders | 34/207 | 4/58 | 4/57 | 2/57 | 4/60 |
| Infusion site swellingGeneral disorders | 0/207 | 6/58 | 5/57 | 2/57 | 0/60 |
| FatigueGeneral disorders | 5/207 | 0/58 | 5/57 | 1/57 | 0/60 |
| NasopharyngitisInfections and infestations | 12/207 | 2/58 | 4/57 | 1/57 | 1/60 |
| NauseaGastrointestinal disorders | 10/207 | 1/58 | 0/57 | 2/57 | 4/60 |
| FallInjury, poisoning and procedural complications | 5/207 | 1/58 | 3/57 | 0/57 | 0/60 |
| Infusion site painGeneral disorders | 0/207 | 2/58 | 3/57 | 2/57 | 0/60 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/207 | 1/58 | 3/57 | 1/57 | 0/60 |
| Back painMusculoskeletal and connective tissue disorders | 5/207 | 1/58 | 3/57 | 1/57 | 1/60 |
Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS.
| Age, Categorical(Participants) | Pre-randomization Safety Data Set (PSDS) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 150 |
| >=65 years | 57 |
| Age, Continuous(years) | Pre-randomization Safety Data Set (PSDS) |
|---|---|
| Mean | 56.5 ± 12.76 |
| Sex: Female, Male(Participants) | Pre-randomization Safety Data Set (PSDS) |
|---|---|
| Female | 76 |
| Male | 131 |
| Region of Enrollment(Participants) | Pre-randomization Safety Data Set (PSDS) |
|---|---|
| United States | 25 |
| Czechia | 6 |
| Japan | 15 |
| United Kingdom | 6 |
| Spain | 16 |
| Canada | 19 |
| Netherlands | 7 |
| Belgium | 2 |
| Finland | 1 |
| Poland | 8 |
| Italy | 32 |
| Israel | 2 |
| Australia | 6 |
| France | 9 |
| Germany | 51 |
| Estonia | 2 |
The record gives a start of Mar 2012, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2018, 1 year 10 months after primary completion. A results delay was requested in Sep 2017.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →