| Primary | Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period | Relapse is defined as an increase of at least 1 INCAT score point (except for the increase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. | Intention-to-treat Set (ITTS): The ITTS consists of all randomized subjects who received at least 1 dose of IgPro20 / placebo and satisfied inclusion criterion #1 (diagnosis of CIDP). | Posted | | Number | | percentage of subjects | | Up to 25 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. | | OG002 | Placebo | Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00032.8
- OG00138.6
- OG00263.2
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Fisher Exact | | =0.007 | | Difference in Percent | -24.6 | | | 2-Sided | 95 | -40.7 | -6.21 | | | | | Superiority | | | | | Fisher Exact | | <0.001 | |
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| Secondary | 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. | ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure. | Posted | | Median | Full Range | units on a scale | | Baseline and up to 25 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. |
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| Secondary | 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. | ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.. | Posted | | Median | Full Range | Kilopascal (kPa) | | Baseline and up to 25 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. | | OG002 | Placebo | |
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| Secondary | 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). | ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure. | Posted | | Median | Full Range | units on a scale | | Baseline and up to 25 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. | | OG002 | Placebo | Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study. |
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| Secondary | 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). | ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure. | Posted | | Median | Full Range | units on a scale | | Baseline and up to 25 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. | | OG002 | Placebo | Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study. |
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| Secondary | Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period | | | Posted | | Median | 95% Confidence Interval | Days | | Up to 25 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. | | OG002 | Placebo | Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study. |
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| Secondary | Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period | | Safety Data Set (SDS): The SDS consists of all randomized subjects who received at least 1 dose of IgPro20 or placebo. | Posted | | Number | | Adverse events/Infusion | | Up to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. | | OG002 | Placebo | Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study. |
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| Secondary | Number of Subjects With Adverse Events During the SC Treatment Period | | | Posted | | Count of Participants | | Participants | | Up to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. | | OG002 | Placebo | Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study. |
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| Secondary | Percentage of Subjects With Adverse Events During the SC Treatment Period | | | Posted | | Number | | percentage of subjects | | Up to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro20 (0.4) | IgPro20 (0.4 g/kg body weight): 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. | | OG001 | IgPro20 (0.2) | IgPro20 (0.2 g/kg body weight): 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. | | OG002 | Placebo | Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study. |
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| Secondary | 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. | 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. | Posted | | Median | 95% Confidence Interval | Days | | Up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during IgPro10 Restabilization. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks. |
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| Secondary | 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. | PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure. | Posted | | Mean | Standard Deviation | kPa | | Reference visit and up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks. |
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| Secondary | 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). | PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Reference visit and up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks. |
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| Secondary | 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). | PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Reference visit and up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks. |
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| Secondary | 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. | PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Reference visit and up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks. |
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| Secondary | Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy | | | Posted | | Number | | Adverse events/Infusion | | Up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks. |
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| Secondary | Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy | | | Posted | | Number | | participants | | Up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks. |
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| Secondary | Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy | | | Posted | | Number | | percentage of subjects | | Up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP deterioration during IgG Dependency received IVIG treatment with IgPro10 during the IgPro10 Restabilization. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses (depending on time needed for restabilization) of 1 g/kg bw every 3 weeks. |
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| Secondary | 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. | Rescue Medication Safety Data Set (RSDS): The RSDS consists of subjects of the SDS who received at least 1 dose of IgPro10 rescue medication. | Posted | | Median | 95% Confidence Interval | Days | | Up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks. |
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| Secondary | Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy | | | Posted | | Number | | Adverse events/Infusion | | Up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks. |
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| Secondary | Number of Subjects With Adverse Events During IgPro10 Rescue Therapy | | | Posted | | Number | | participants | | Up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks. |
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| Secondary | Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy | | | Posted | | Number | | percentage of subjects | | Up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks. |
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| Secondary | 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. | RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure. | Posted | | Mean | Standard Deviation | kPa | | Before first rescue IgPro10 infusion and up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks. |
| |
| Secondary | 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). | RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Before first rescue IgPro10 infusion and up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks. |
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| Secondary | 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). | RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Before first rescue IgPro10 infusion and up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks. |
| |
| Secondary | 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. | RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Before first rescue IgPro10 infusion and up to 13 weeks | | | | ID | Title | Description |
|---|
| OG000 | IgPro10 | Subjects who experienced CIDP relapse during the IgPro20 SC Period received IVIG treatment with IgPro10 during the IgPro10 Rescue. IgPro10 as 1 loading dose of 2 g/kg bw, followed by 3 or 4 maintenance doses of 1 g/kg bw every 3 weeks. |
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