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

• Sponsor: CSL Behring (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01545076
• Collaborator: ICON Clinical Research (Industry)
• Enrollment: 208
• Locations: 91
• Arms: 3
• Duration (Months): 54
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inflammatory Demyelinating Polyneuropathy; Polyradiculoneuropathy	Biological: IgPro20 (low dose); Biological: Placebo; Biological: IgPro10; Biological: IgPro20 (high dose)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 208 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IgPro20 low dose	Biological: IgPro20 (low dose); 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); Other Names: Hizentra ; Biological: IgPro10; 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.
Experimental: IgPro20 high dose	Biological: IgPro10; 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.; Biological: IgPro20 (high dose); 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); Other Names: Hizentra
Placebo Comparator: Placebo	Biological: Placebo; 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.; Biological: IgPro10; 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.

Outcome Measures

Primary Outcome Measures

1. Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period [Up to 25 weeks]

   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.

Secondary Outcome Measures

1. Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period [Baseline and up to 25 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.

2. Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period [Baseline and up to 25 weeks]

   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.

3. Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period [Baseline and up to 25 weeks]

   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).

4. Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period [Baseline and up to 25 weeks]

   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).

5. Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period [Up to 25 weeks]

6. Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period [Up to 28 weeks]

7. Number of Subjects With Adverse Events During the SC Treatment Period [Up to 28 weeks]

8. Percentage of Subjects With Adverse Events During the SC Treatment Period [Up to 28 weeks]

9. Time to Improvement During IgPro10 Re-stabilization Therapy [Up to 13 weeks]

   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.

10. Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy [Reference visit and up to 13 weeks]

    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.

11. Change in MRC Sum Score During IgPro10 Re-stabilization Therapy [Reference visit and up to 13 weeks]

    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).

12. Change in R-ODS During IgPro10 Re-stabilization Therapy [Reference visit and up to 13 weeks]

    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).

13. Change in INCAT During IgPro10 Re-stabilization Therapy [Reference visit and up to 13 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.

14. Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy [Up to 13 weeks]

15. Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy [Up to 13 weeks]

16. Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy [Up to 13 weeks]

17. Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy [Up to 13 weeks]

    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.

18. Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy [Up to 13 weeks]

19. Number of Subjects With Adverse Events During IgPro10 Rescue Therapy [Up to 13 weeks]

20. Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy [Up to 13 weeks]

21. Change in Mean Grip Strength During IgPro10 Rescue Therapy [Before first rescue IgPro10 infusion and up to 13 weeks]

    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.

22. Change in MRC Sum Score During IgPro10 Rescue Therapy [Before first rescue IgPro10 infusion and up to 13 weeks]

    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).

23. Change in R-ODS During IgPro10 Rescue Therapy [Before first rescue IgPro10 infusion and up to 13 weeks]

    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).

24. Change in INCAT During IgPro10 Rescue Therapy [Before first rescue IgPro10 infusion and up to 13 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.

• An IVIG treatment during the last 8 weeks prior to enrollment.

• Age ≥18 years.

• Written informed consent for study participation obtained before undergoing any study-specific procedures.

Exclusion Criteria:

• Any polyneuropathy of other causes

• Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments

• Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study

• History of thrombotic episodes within the 2 years prior to enrolment

• Known allergic or other severe reactions to blood products including intolerability to previous IVIG

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site reference 8400181	Birmingham	Alabama	United States	35233
2	Site reference 8400173	Phoenix	Arizona	United States	85013
3	Site reference 8400172	Phoenix	Arizona	United States	85018
4	Site reference 8400167	Los Angeles	California	United States	90033
5	Site reference 8400077	Centennial	Colorado	United States	80112
6	Site Reference 8400352	Washington	District of Columbia	United States	20037
7	Site reference 8400214	Miami	Florida	United States	33136
8	Site reference 8400162	Chicago	Illinois	United States	60611
9	Site Reference 8400247	Chicago	Illinois	United States	60611
10	Site Reference 8400215	Indianapolis	Indiana	United States	46202
11	Site reference 8400166	Kansas City	Kansas	United States	66160
12	Site Reference 8400347	New Brunswick	New Jersey	United States	08901
13	Site reference 8400169	New York	New York	United States	10021
14	Site reference 8400179	New York	New York	United States	10021
15	Site reference 8400182	Charlotte	North Carolina	United States	28204
16	Site Reference 8400346	Durham	North Carolina	United States	27710
17	Site reference 8400178	Columbus	Ohio	United States	43210
18	Site reference 8400217	Oklahoma City	Oklahoma	United States	73104
19	Site Reference 8400177	Nashville	Tennessee	United States	37232
20	Site reference 8400164	Houston	Texas	United States	77030
21	Site Reference 8400268	Charlottesville	Virginia	United States	22908
22	Site Reference 8400340	Seattle	Washington	United States	98195
23	Site Reference 0360017	Herston	Queensland	Australia	4029
24	Site reference 0360011	Fitzroy	Victoria	Australia
25	Site reference 0360008	Southport		Australia
26	Site reference 0560003	Leuven		Belgium
27	Site Reference 1240048	Vancouver	British Columbia	Canada	V5Z 1M9
28	Site Reference 1240051	Montreal	Quebec	Canada	H3A 2B4
29	Site reference 1240006	Edmonton		Canada
30	Site reference 1240007	Quebec		Canada
31	Site reference 1240009	Toronto		Canada
32	Site reference 2030002	Hradec Kralove		Czechia
33	Site reference 2030009	Hradec Kralove		Czechia
34	Site reference 2030003	Prague		Czechia
35	Site Reference 2330002	Tallinn		Estonia	10138
36	Site Reference 2330003	Tallinn		Estonia	10617
37	Site reference 2460002	Helsinki		Finland
38	Site reference 2500024	Clermont-Ferrand		France
39	Site reference 2500013	Marseille		France
40	Site reference 2500022	Nice		France
41	Site reference 2500019	Pessac		France
42	Site reference 2760048	Berlin		Germany
43	Site reference 2760069	Berlin		Germany
44	Site reference 2760072	Berlin		Germany
45	Site reference 2760049	Bochum		Germany
46	Site reference 2760075	Duesseldorf		Germany
47	Site Reference 2760094	Essen		Germany	45122
48	Site reference 2760052	Essen		Germany
49	Site reference 2760036	Göttingen		Germany
50	Site reference 2760053	Göttingen		Germany
51	Site reference 2760054	Hannover		Germany
52	Site Reference 2760113	Ibbenbueren		Germany	49477
53	Site reference 2760080	Koeln		Germany
54	Site reference 2760055	Leipzig		Germany
55	Site reference 2760047	Potsdam		Germany
56	Site reference 2760039	Wuerzburg		Germany
57	Site reference 3760005	Haifa		Israel
58	Site reference 3760002	Tel Aviv		Israel
59	Site reference 3800026	Chieti		Italy
60	Site reference 3800027	Firenze		Italy
61	Site reference 3800028	Genova		Italy
62	Site reference 3800031	Milano		Italy
63	Site reference 3800035	Roma		Italy
64	Site reference 3800036	Roma		Italy
65	Site reference 3800030	Rozzano		Italy
66	Site reference 3800037	Torino		Italy
67	Site Reference 3920040	Aomori		Japan	030-8553
68	Site Reference 3920042	Aomori		Japan	030-8553
69	Site reference 3920038	Chiba		Japan
70	Site reference 3920061	Kanagawa		Japan
71	Site reference 3920045	Matsumoto		Japan
72	Site reference 3920058	Osaka		Japan
73	Site reference 3920037	Saitama		Japan
74	Site reference 3920034	Tokushima		Japan
75	Site Reference 3920065	Tokyo		Japan	113-8431
76	Site Reference 3920062	Tokyo		Japan	187-8551
77	Site reference 3920032	Tokyo		Japan
78	Site reference 3920035	Yamaguchi		Japan
79	Site reference 5280001	Amsterdam		Netherlands
80	Site reference 5280005	Maastricht		Netherlands
81	Site reference 5280004	Utrecht		Netherlands
82	Site Reference 6160058	Gdansk		Poland	80-803
83	Site Reference 6160060	Lodz		Poland	90-324
84	Site Reference 6160055	Lublin		Poland	20-954
85	Site reference 7240010	Barcelona		Spain
86	Site reference 7240011	Barcelona		Spain
87	Site reference 7240013	Madrid		Spain
88	Site reference 7240014	Madrid		Spain
89	Site reference 7240016	Sevilla		Spain
90	Site reference 8260019	London		United Kingdom
91	Site Reference 8260032	Manchester		United Kingdom	M6 8HD

Sponsors and Collaborators

• CSL Behring
• ICON Clinical Research

Investigators

• Principal Investigator: Prof. Dr. Ivo N. van Schaik, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CSL Behring
• ClinicalTrials.gov Identifier: NCT01545076
• Other Study ID Numbers: IgPro20_3003
• First Posted: Mar 6, 2012
• Last Update Posted: Jul 5, 2018
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Polyradiculoneuropathy; Immunoglobulin G

Study Results

Participant Flow

Arm/Group Title	IgPro10 Re-stabilization	IgPro20 (0.4)	IgPro20 (0.2)	Placebo	IgPro10 Rescue
Arm/Group Description	Subjects who experienced CIDP qualified for IVIG re-stabilization treatment with IgPro10 (10% IgG preparation for intravenous administration).	Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. IgPro20 [0.4 g/kg body weight (bw)]: 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.	Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. IgPro20 [0.2 g/kg body weight (bw)]: 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.	Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. Placebo: 2% human albumin administered by weekly SC infusions.	Subjects with CIDP relapse during the SC Treatment Period received IgPro10 (10% IgG preparation for intravenous administration) as rescue medication.
Period Title: IgPro10 Restabilization Period
STARTED	208	0	0	0	0
COMPLETED	172	0	0	0	0
NOT COMPLETED	36	0	0	0	0
Period Title: IgPro10 Restabilization Period
STARTED	0	58	57	57	0
COMPLETED	0	39	36	21	0
NOT COMPLETED	0	19	21	36	0
Period Title: IgPro10 Restabilization Period
STARTED	0	0	0	0	60
COMPLETED	0	0	0	0	60
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Pre-randomization Safety Data Set (PSDS)
Arm/Group Description	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.
Overall Participants	207
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	150 72.5%
>=65 years	57 27.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.5 (12.76)
Sex: Female, Male (Count of Participants)
Female	76 36.7%
Male	131 63.3%
Region of Enrollment (Count of Participants)
United States	25 12.1%
Czechia	6 2.9%
Japan	15 7.2%
United Kingdom	6 2.9%
Spain	16 7.7%
Canada	19 9.2%
Netherlands	7 3.4%
Belgium	2 1%
Finland	1 0.5%
Poland	8 3.9%
Italy	32 15.5%
Israel	2 1%
Australia	6 2.9%
France	9 4.3%
Germany	51 24.6%
Estonia	2 1%

Outcome Measures

1. Primary Outcome

Title	Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	58	57	57
Number [percentage of subjects]	32.8	38.6	63.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.2), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	=0.007
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-24.6
	Confidence Interval	(2-Sided) 95%; -40.7 to -6.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.4), Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent
	Estimated Value	-30.4
	Confidence Interval	(2-Sided) 95%; -46.0 to -12.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	57	56	57
Median (Full Range) [units on a scale]	0	0	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.2), Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.005
	Comments
	Method	Wilcoxon rank sum
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	0
	Confidence Interval	(2-Sided) 95%; -1 to 0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.4), Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon rank sum
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	-1
	Confidence Interval	(2-Sided) 95%; -1 to 0
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure..

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	57	56	57
Median (Full Range) [Kilopascal (kPa)]	-2.7	-0.6	-6.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.2), Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.004
	Comments
	Method	Wilcoxon rank sum
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	7.6
	Confidence Interval	(2-Sided) 95%; 2 to 14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.4), Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.014
	Comments
	Method	Wilcoxon rank sum
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	5.7
	Confidence Interval	(2-Sided) 95%; 0.7 to 11.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	57	56	57
Median (Full Range) [units on a scale]	0	0	-2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.2), Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.003
	Comments
	Method	Wilcoxon rank sum
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	2
	Confidence Interval	(2-Sided) 95%; 1 to 4
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.4), Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.002
	Comments
	Method	Wilcoxon rank sum
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	2
	Confidence Interval	(2-Sided) 95%; 1 to 4
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period
Description	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

Outcome Measure Data

Analysis Population Description

ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	53	53	52
Median (Full Range) [units on a scale]	0	-2	-3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.2), Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.03
	Comments
	Method	Wilcoxon rank sum
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	3
	Confidence Interval	(2-Sided) 95%; 0 to 9
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IgPro20 (0.4), Placebo
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon rank sum
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	5
	Confidence Interval	(2-Sided) 95%; 2 to 9
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period
Time Frame	Up to 25 weeks

Outcome Measure Data

Analysis Population Description

ITTS

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	58	57	57
Median (95% Confidence Interval) [Days]	NA	NA	79.0

7. Secondary Outcome

Title	Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

Safety Data Set (SDS): The SDS consists of all randomized subjects who received at least 1 dose of IgPro20 or placebo.

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	58	57	57
Number [Adverse events/Infusion]	0.051	0.079	0.034

8. Secondary Outcome

Title	Number of Subjects With Adverse Events During the SC Treatment Period
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

SDS

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	58	57	57
Count of Participants [Participants]	30 14.5%	33 NaN	21 NaN

9. Secondary Outcome

Title	Percentage of Subjects With Adverse Events During the SC Treatment Period
Time Frame	Up to 28 weeks

Outcome Measure Data

Analysis Population Description

SDS

Arm/Group Title	IgPro20 (0.4)	IgPro20 (0.2)	Placebo
Arm/Group Description	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.	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.	Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Measure Participants	58	57	57
Number [percentage of subjects]	51.7	57.9	36.8

10. Secondary Outcome

Title	Time to Improvement During IgPro10 Re-stabilization Therapy
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	207
Median (95% Confidence Interval) [Days]	23

11. Secondary Outcome

Title	Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy
Description	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

Outcome Measure Data

Analysis Population Description

PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	202
Mean (Standard Deviation) [kPa]	11.27 (16.89)

12. Secondary Outcome

Title	Change in MRC Sum Score During IgPro10 Re-stabilization Therapy
Description	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

Outcome Measure Data

Analysis Population Description

PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	203
Mean (Standard Deviation) [units on a scale]	3.4 (4.9)

13. Secondary Outcome

Title	Change in R-ODS During IgPro10 Re-stabilization Therapy
Description	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

Outcome Measure Data

Analysis Population Description

PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	166
Mean (Standard Deviation) [units on a scale]	4.7 (14.14)

14. Secondary Outcome

Title	Change in INCAT During IgPro10 Re-stabilization Therapy
Description	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

Outcome Measure Data

Analysis Population Description

PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	205
Mean (Standard Deviation) [units on a scale]	-1.1 (1.2)

15. Secondary Outcome

Title	Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy
Time Frame	Up to 13 weeks

Outcome Measure Data

Analysis Population Description

PSDS

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	207
Number [Adverse events/Infusion]	0.175

16. Secondary Outcome

Title	Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time Frame	Up to 13 weeks

Outcome Measure Data

Analysis Population Description

PSDS

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	207
Number [participants]	100 48.3%

17. Secondary Outcome

Title	Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy
Time Frame	Up to 13 weeks

Outcome Measure Data

Analysis Population Description

PSDS

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	207
Number [percentage of subjects]	48.3

18. Secondary Outcome

Title	Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy
Description	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

Outcome Measure Data

Analysis Population Description

Rescue Medication Safety Data Set (RSDS): The RSDS consists of subjects of the SDS who received at least 1 dose of IgPro10 rescue medication.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	60
Median (95% Confidence Interval) [Days]	23

19. Secondary Outcome

Title	Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy
Time Frame	Up to 13 weeks

Outcome Measure Data

Analysis Population Description

RSDS

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	60
Number [Adverse events/Infusion]	0.142

20. Secondary Outcome

Title	Number of Subjects With Adverse Events During IgPro10 Rescue Therapy
Time Frame	Up to 13 weeks

Outcome Measure Data

Analysis Population Description

RSDS

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	60
Number [participants]	17 8.2%

21. Secondary Outcome

Title	Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy
Time Frame	Up to 13 weeks

Outcome Measure Data

Analysis Population Description

RSDS

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	60
Number [percentage of subjects]	28.3

22. Secondary Outcome

Title	Change in Mean Grip Strength During IgPro10 Rescue Therapy
Description	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

Outcome Measure Data

Analysis Population Description

RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	35
Mean (Standard Deviation) [kPa]	16.3 (17.58)

23. Secondary Outcome

Title	Change in MRC Sum Score During IgPro10 Rescue Therapy
Description	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

Outcome Measure Data

Analysis Population Description

RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	35
Mean (Standard Deviation) [units on a scale]	6.8 (5.28)

24. Secondary Outcome

Title	Change in R-ODS During IgPro10 Rescue Therapy
Description	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

Outcome Measure Data

Analysis Population Description

RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	29
Mean (Standard Deviation) [units on a scale]	14.0 (14.69)

25. Secondary Outcome

Title	Change in INCAT During IgPro10 Rescue Therapy
Description	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

Outcome Measure Data

Analysis Population Description

RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.

Arm/Group Title	IgPro10
Arm/Group Description	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.
Measure Participants	45
Mean (Standard Deviation) [units on a scale]	-1.3 (1.31)

Adverse Events

Time Frame	4.5 years
Arm/Group Title	IgPro10 Restabilization		IgPro20 (0.4)		IgPro20 (0.2)		Placebo		IgPro10 Rescue
Arm/Group Description	IgPro10: 10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during 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.		IgPro20 (0.4 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.		IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.		Placebo: 2% human albumin administered by weekly SC infusions during the IgPro20 SC treatment period of the study.		IgPro10: 10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during 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.
All Cause Mortality
	IgPro10 Restabilization		IgPro20 (0.4)		IgPro20 (0.2)		Placebo		IgPro10 Rescue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/207 (0%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Serious Adverse Events
	IgPro10 Restabilization		IgPro20 (0.4)		IgPro20 (0.2)		Placebo		IgPro10 Rescue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/207 (5.3%)		2/58 (3.4%)		3/57 (5.3%)		1/57 (1.8%)		2/60 (3.3%)
Blood and lymphatic system disorders
Anemia	0/207 (0%)		1/58 (1.7%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Cardiac disorders
Cardiac failure congestive	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Pericarditis	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Gastrointestinal disorders
Inguinal hernia	0/207 (0%)		0/58 (0%)		0/57 (0%)		1/57 (1.8%)		0/60 (0%)
Abdominal pain	0/207 (0%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		1/60 (1.7%)
Hepatobiliary disorders
Choleithiasis	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Cholecystitis acute	0/207 (0%)		1/58 (1.7%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Immune system disorders
Hypersensitivity	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Infections and infestations
Sepsis	0/207 (0%)		1/58 (1.7%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Bacterial infection	0/207 (0%)		0/58 (0%)		1/57 (1.8%)		0/57 (0%)		0/60 (0%)
Device related infection	0/207 (0%)		0/58 (0%)		1/57 (1.8%)		0/57 (0%)		0/60 (0%)
Investigations
Blood pressure diastolic increased	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Musculoskeletal and connective tissue disorders
Arthropathy	0/207 (0%)		1/58 (1.7%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Arthralgia	0/207 (0%)		0/58 (0%)		1/57 (1.8%)		0/57 (0%)		0/60 (0%)
Fracture nonunion	0/207 (0%)		0/58 (0%)		1/57 (1.8%)		0/57 (0%)		0/60 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma	0/207 (0%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		1/60 (1.7%)
Nervous system disorders
Migraine	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Chronic inflammatory demyelinating polyradiculoneuropathy	2/207 (1%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Syncope	0/207 (0%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		1/60 (1.7%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Respiratory failure	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Pulmonary hypertension	0/207 (0%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		1/60 (1.7%)
Skin and subcutaneous tissue disorders
Rash	1/207 (0.5%)		0/58 (0%)		0/57 (0%)		0/57 (0%)		0/60 (0%)
Dermatitis allergic	0/207 (0%)		0/58 (0%)		1/57 (1.8%)		0/57 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	IgPro10 Restabilization		IgPro20 (0.4)		IgPro20 (0.2)		Placebo		IgPro10 Rescue
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	50/207 (24.2%)		20/58 (34.5%)		22/57 (38.6%)		15/57 (26.3%)		7/60 (11.7%)
Gastrointestinal disorders
Nausea	10/207 (4.8%)	12	1/58 (1.7%)	1	0/57 (0%)	0	2/57 (3.5%)	2	4/60 (6.7%)	4
General disorders
Fatigue	5/207 (2.4%)	11	0/58 (0%)	0	5/57 (8.8%)	5	1/57 (1.8%)	1	0/60 (0%)	0
Infusion site erythema	0/207 (0%)	0	10/58 (17.2%)	28	5/57 (8.8%)	11	0/57 (0%)	0	0/60 (0%)	0
Infusion site swelling	0/207 (0%)	0	6/58 (10.3%)	8	5/57 (8.8%)	8	2/57 (3.5%)	2	0/60 (0%)	0
Infusion site induration	0/207 (0%)	0	3/58 (5.2%)	3	2/57 (3.5%)	10	1/57 (1.8%)	1	0/60 (0%)	0
Infusion site pain	0/207 (0%)	0	2/58 (3.4%)	2	3/57 (5.3%)	15	2/57 (3.5%)	2	0/60 (0%)	0
Infusion site warmth	0/207 (0%)	0	3/58 (5.2%)	3	0/57 (0%)	0	0/57 (0%)	0	0/60 (0%)	0
Infections and infestations
Nasopharyngitis	12/207 (5.8%)	12	2/58 (3.4%)	2	4/57 (7%)	6	1/57 (1.8%)	1	1/60 (1.7%)	1
Urinary tract infection	1/207 (0.5%)	2	0/58 (0%)	0	1/57 (1.8%)	1	3/57 (5.3%)	3	0/60 (0%)	0
Upper respiratory tract infection	2/207 (1%)	2	2/58 (3.4%)	2	3/57 (5.3%)	3	2/57 (3.5%)	2	0/60 (0%)	0
Injury, poisoning and procedural complications
Fall	5/207 (2.4%)	5	1/58 (1.7%)	1	3/57 (5.3%)	8	0/57 (0%)	0	0/60 (0%)	0
Musculoskeletal and connective tissue disorders
Pain in extremity	3/207 (1.4%)	3	3/58 (5.2%)	3	1/57 (1.8%)	1	0/57 (0%)	0	0/60 (0%)	0
Arthralgia	3/207 (1.4%)	3	1/58 (1.7%)	1	3/57 (5.3%)	3	1/57 (1.8%)	1	0/60 (0%)	0
Back pain	5/207 (2.4%)	5	1/58 (1.7%)	1	3/57 (5.3%)	4	1/57 (1.8%)	1	1/60 (1.7%)	1
Nervous system disorders
Headache	34/207 (16.4%)	53	4/58 (6.9%)	4	4/57 (7%)	5	2/57 (3.5%)	2	4/60 (6.7%)	6

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.