Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

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