Trial Outcomes & Findings for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) (NCT NCT01545076)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

208 participants

Primary outcome timeframe

Up to 25 weeks

Results posted on

2018-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	IgPro10 Re-stabilization Subjects who experienced CIDP qualified for IVIG re-stabilization treatment with IgPro10 (10% IgG preparation for intravenous administration).	IgPro20 (0.4) 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.	IgPro20 (0.2) 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.	Placebo Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. Placebo: 2% human albumin administered by weekly SC infusions.	IgPro10 Rescue Subjects with CIDP relapse during the SC Treatment Period received IgPro10 (10% IgG preparation for intravenous administration) as rescue medication.
IgPro10 Restabilization Period STARTED	208	0	0	0	0
IgPro10 Restabilization Period COMPLETED	172	0	0	0	0
IgPro10 Restabilization Period NOT COMPLETED	36	0	0	0	0
IgPro20 Subcutaneous Treatment Period STARTED	0	58	57	57	0
IgPro20 Subcutaneous Treatment Period COMPLETED	0	39	36	21	0
IgPro20 Subcutaneous Treatment Period NOT COMPLETED	0	19	21	36	0
IgPro10 Rescue Period STARTED	0	0	0	0	60
IgPro10 Rescue Period COMPLETED	0	0	0	0	60
IgPro10 Rescue Period NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	IgPro10 Re-stabilization Subjects who experienced CIDP qualified for IVIG re-stabilization treatment with IgPro10 (10% IgG preparation for intravenous administration).	IgPro20 (0.4) 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.	IgPro20 (0.2) 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.	Placebo Subjects completing IVIG re-stabilization went on to the IgPro20 Subcutaneous (SC) Treatment. Placebo: 2% human albumin administered by weekly SC infusions.
IgPro10 Restabilization Period Adverse Event	4	0	0	0
IgPro10 Restabilization Period Physician Decision	2	0	0	0
IgPro10 Restabilization Period Protocol Violation	1	0	0	0
IgPro10 Restabilization Period Failure to meet randomization criteria	22	0	0	0
IgPro10 Restabilization Period Withdrawal by Subject	7	0	0	0
IgPro20 Subcutaneous Treatment Period Physician Decision	0	0	0	1
IgPro20 Subcutaneous Treatment Period Lack of Efficacy	0	10	18	32
IgPro20 Subcutaneous Treatment Period Adverse Event	0	1	1	0
IgPro20 Subcutaneous Treatment Period Withdrawal by Subject	0	8	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-randomization Safety Data Set (PSDS) n=207 Participants Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	150 Participants n=5 Participants
Age, Categorical >=65 years	57 Participants n=5 Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 12.76 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	131 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants
Region of Enrollment Czechia	6 Participants n=5 Participants
Region of Enrollment Japan	15 Participants n=5 Participants
Region of Enrollment United Kingdom	6 Participants n=5 Participants
Region of Enrollment Spain	16 Participants n=5 Participants
Region of Enrollment Canada	19 Participants n=5 Participants
Region of Enrollment Netherlands	7 Participants n=5 Participants
Region of Enrollment Belgium	2 Participants n=5 Participants
Region of Enrollment Finland	1 Participants n=5 Participants
Region of Enrollment Poland	8 Participants n=5 Participants
Region of Enrollment Italy	32 Participants n=5 Participants
Region of Enrollment Israel	2 Participants n=5 Participants
Region of Enrollment Australia	6 Participants n=5 Participants
Region of Enrollment France	9 Participants n=5 Participants
Region of Enrollment Germany	51 Participants n=5 Participants
Region of Enrollment Estonia	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 25 weeks

Population: 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).

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=58 Participants 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) n=57 Participants 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 n=57 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period	32.8 percentage of subjects	38.6 percentage of subjects	63.2 percentage of subjects

SECONDARY outcome

Timeframe: Baseline and up to 25 weeks

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

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=57 Participants 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) n=56 Participants 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 n=57 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period	0 units on a scale Interval -2.0 to 3.0	0 units on a scale Interval -2.0 to 5.0	1 units on a scale Interval -1.0 to 4.0

SECONDARY outcome

Timeframe: Baseline and up to 25 weeks

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

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=57 Participants 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) n=56 Participants 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 n=57 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period	-2.7 Kilopascal (kPa) Interval -80.0 to 55.0	-0.6 Kilopascal (kPa) Interval -80.0 to 55.0	-6.6 Kilopascal (kPa) Interval -51.0 to 22.0

SECONDARY outcome

Timeframe: Baseline and up to 25 weeks

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

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).

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=57 Participants 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) n=56 Participants 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 n=57 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period	0 units on a scale Interval -12.0 to 7.0	0 units on a scale Interval -16.0 to 14.0	-2 units on a scale Interval -19.0 to 6.0

SECONDARY outcome

Timeframe: Baseline and up to 25 weeks

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

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).

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=53 Participants 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) n=53 Participants 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 n=52 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period	0 units on a scale Interval -49.0 to 17.0	-2 units on a scale Interval -41.0 to 100.0	-3 units on a scale Interval -43.0 to 13.0

SECONDARY outcome

Timeframe: Up to 25 weeks

Population: ITTS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=58 Participants 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) n=57 Participants 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 n=57 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period	NA Days Median times could not be calculated due to insufficient number of participants with events	NA Days Interval 113.0 to Median times could not be calculated due to insufficient number of participants with events	79.0 Days Interval 57.0 to 125.0

SECONDARY outcome

Timeframe: Up to 28 weeks

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

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=58 Participants 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) n=57 Participants 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 n=57 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period	0.051 Adverse events/Infusion	0.079 Adverse events/Infusion	0.034 Adverse events/Infusion

SECONDARY outcome

Timeframe: Up to 28 weeks

Population: SDS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=58 Participants 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) n=57 Participants 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 n=57 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Number of Subjects With Adverse Events During the SC Treatment Period	30 Participants	33 Participants	21 Participants

SECONDARY outcome

Timeframe: Up to 28 weeks

Population: SDS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=58 Participants 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) n=57 Participants 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 n=57 Participants Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Percentage of Subjects With Adverse Events During the SC Treatment Period	51.7 percentage of subjects	57.9 percentage of subjects	36.8 percentage of subjects

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=207 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Time to Improvement During IgPro10 Re-stabilization Therapy	23 Days Interval 22.0 to 23.0	—	—

SECONDARY outcome

Timeframe: Reference visit and up to 13 weeks

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

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=202 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy	11.27 kPa Standard Deviation 16.89	—	—

SECONDARY outcome

Timeframe: Reference visit and up to 13 weeks

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

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).

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=203 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in MRC Sum Score During IgPro10 Re-stabilization Therapy	3.4 units on a scale Standard Deviation 4.9	—	—

SECONDARY outcome

Timeframe: Reference visit and up to 13 weeks

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

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).

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=166 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in R-ODS During IgPro10 Re-stabilization Therapy	4.7 units on a scale Standard Deviation 14.14	—	—

SECONDARY outcome

Timeframe: Reference visit and up to 13 weeks

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

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=205 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in INCAT During IgPro10 Re-stabilization Therapy	-1.1 units on a scale Standard Deviation 1.2	—	—

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: PSDS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=207 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy	0.175 Adverse events/Infusion	—	—

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: PSDS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=207 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy	100 participants	—	—

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: PSDS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=207 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy	48.3 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Up to 13 weeks

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

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=60 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy	23 Days Interval 22.0 to 49.0	—	—

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: RSDS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=60 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy	0.142 Adverse events/Infusion	—	—

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: RSDS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=60 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Number of Subjects With Adverse Events During IgPro10 Rescue Therapy	17 participants	—	—

SECONDARY outcome

Timeframe: Up to 13 weeks

Population: RSDS

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=60 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy	28.3 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Before first rescue IgPro10 infusion and up to 13 weeks

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

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=35 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in Mean Grip Strength During IgPro10 Rescue Therapy	16.3 kPa Standard Deviation 17.58	—	—

SECONDARY outcome

Timeframe: Before first rescue IgPro10 infusion and up to 13 weeks

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

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).

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=35 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in MRC Sum Score During IgPro10 Rescue Therapy	6.8 units on a scale Standard Deviation 5.28	—	—

SECONDARY outcome

Timeframe: Before first rescue IgPro10 infusion and up to 13 weeks

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

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).

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=29 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in R-ODS During IgPro10 Rescue Therapy	14.0 units on a scale Standard Deviation 14.69	—	—

SECONDARY outcome

Timeframe: Before first rescue IgPro10 infusion and up to 13 weeks

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

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.

Outcome measures

Outcome measures
Measure	IgPro20 (0.4) n=45 Participants 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) 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 Placebo: 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
Change in INCAT During IgPro10 Rescue Therapy	-1.3 units on a scale Standard Deviation 1.31	—	—

Adverse Events

IgPro10 Restabilization

Serious events: 11 serious events

Other events: 50 other events

Deaths: 0 deaths

IgPro20 (0.4)

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

IgPro20 (0.2)

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

IgPro10 Rescue

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	IgPro10 Restabilization n=207 participants at risk 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) n=58 participants at risk 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) n=57 participants at risk IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.	Placebo n=57 participants at risk Placebo: 2% human albumin administered by weekly SC infusions during the IgPro20 SC treatment period of the study.	IgPro10 Rescue n=60 participants at risk 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.
Investigations Blood pressure diastolic increased	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	1.7% 1/60 • 4.5 years
Cardiac disorders Cardiac failure congestive	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Cardiac disorders Pericarditis	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Blood and lymphatic system disorders Anemia	0.00% 0/207 • 4.5 years	1.7% 1/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	1.7% 1/60 • 4.5 years
Immune system disorders Hypersensitivity	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Nervous system disorders Migraine	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.97% 2/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Nervous system disorders Syncope	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	1.7% 1/60 • 4.5 years
Gastrointestinal disorders Inguinal hernia	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	1.8% 1/57 • 4.5 years	0.00% 0/60 • 4.5 years
Gastrointestinal disorders Abdominal pain	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	1.7% 1/60 • 4.5 years
Hepatobiliary disorders Choleithiasis	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Hepatobiliary disorders Cholecystitis acute	0.00% 0/207 • 4.5 years	1.7% 1/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Skin and subcutaneous tissue disorders Rash	0.48% 1/207 • 4.5 years	0.00% 0/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	1.8% 1/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/207 • 4.5 years	1.7% 1/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	1.8% 1/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Musculoskeletal and connective tissue disorders Fracture nonunion	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	1.8% 1/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Infections and infestations Sepsis	0.00% 0/207 • 4.5 years	1.7% 1/58 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Infections and infestations Bacterial infection	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	1.8% 1/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Infections and infestations Device related infection	0.00% 0/207 • 4.5 years	0.00% 0/58 • 4.5 years	1.8% 1/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years

Other adverse events

Other adverse events
Measure	IgPro10 Restabilization n=207 participants at risk 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) n=58 participants at risk 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) n=57 participants at risk IgPro20 (0.2 g/kg body weight): 20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly.	Placebo n=57 participants at risk Placebo: 2% human albumin administered by weekly SC infusions during the IgPro20 SC treatment period of the study.	IgPro10 Rescue n=60 participants at risk 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.
Injury, poisoning and procedural complications Fall	2.4% 5/207 • Number of events 5 • 4.5 years	1.7% 1/58 • Number of events 1 • 4.5 years	5.3% 3/57 • Number of events 8 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Nervous system disorders Headache	16.4% 34/207 • Number of events 53 • 4.5 years	6.9% 4/58 • Number of events 4 • 4.5 years	7.0% 4/57 • Number of events 5 • 4.5 years	3.5% 2/57 • Number of events 2 • 4.5 years	6.7% 4/60 • Number of events 6 • 4.5 years
General disorders Fatigue	2.4% 5/207 • Number of events 11 • 4.5 years	0.00% 0/58 • 4.5 years	8.8% 5/57 • Number of events 5 • 4.5 years	1.8% 1/57 • Number of events 1 • 4.5 years	0.00% 0/60 • 4.5 years
General disorders Infusion site erythema	0.00% 0/207 • 4.5 years	17.2% 10/58 • Number of events 28 • 4.5 years	8.8% 5/57 • Number of events 11 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
General disorders Infusion site swelling	0.00% 0/207 • 4.5 years	10.3% 6/58 • Number of events 8 • 4.5 years	8.8% 5/57 • Number of events 8 • 4.5 years	3.5% 2/57 • Number of events 2 • 4.5 years	0.00% 0/60 • 4.5 years
General disorders Infusion site induration	0.00% 0/207 • 4.5 years	5.2% 3/58 • Number of events 3 • 4.5 years	3.5% 2/57 • Number of events 10 • 4.5 years	1.8% 1/57 • Number of events 1 • 4.5 years	0.00% 0/60 • 4.5 years
General disorders Infusion site pain	0.00% 0/207 • 4.5 years	3.4% 2/58 • Number of events 2 • 4.5 years	5.3% 3/57 • Number of events 15 • 4.5 years	3.5% 2/57 • Number of events 2 • 4.5 years	0.00% 0/60 • 4.5 years
General disorders Infusion site warmth	0.00% 0/207 • 4.5 years	5.2% 3/58 • Number of events 3 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Gastrointestinal disorders Nausea	4.8% 10/207 • Number of events 12 • 4.5 years	1.7% 1/58 • Number of events 1 • 4.5 years	0.00% 0/57 • 4.5 years	3.5% 2/57 • Number of events 2 • 4.5 years	6.7% 4/60 • Number of events 4 • 4.5 years
Musculoskeletal and connective tissue disorders Pain in extremity	1.4% 3/207 • Number of events 3 • 4.5 years	5.2% 3/58 • Number of events 3 • 4.5 years	1.8% 1/57 • Number of events 1 • 4.5 years	0.00% 0/57 • 4.5 years	0.00% 0/60 • 4.5 years
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 3/207 • Number of events 3 • 4.5 years	1.7% 1/58 • Number of events 1 • 4.5 years	5.3% 3/57 • Number of events 3 • 4.5 years	1.8% 1/57 • Number of events 1 • 4.5 years	0.00% 0/60 • 4.5 years
Musculoskeletal and connective tissue disorders Back pain	2.4% 5/207 • Number of events 5 • 4.5 years	1.7% 1/58 • Number of events 1 • 4.5 years	5.3% 3/57 • Number of events 4 • 4.5 years	1.8% 1/57 • Number of events 1 • 4.5 years	1.7% 1/60 • Number of events 1 • 4.5 years
Infections and infestations Nasopharyngitis	5.8% 12/207 • Number of events 12 • 4.5 years	3.4% 2/58 • Number of events 2 • 4.5 years	7.0% 4/57 • Number of events 6 • 4.5 years	1.8% 1/57 • Number of events 1 • 4.5 years	1.7% 1/60 • Number of events 1 • 4.5 years
Infections and infestations Urinary tract infection	0.48% 1/207 • Number of events 2 • 4.5 years	0.00% 0/58 • 4.5 years	1.8% 1/57 • Number of events 1 • 4.5 years	5.3% 3/57 • Number of events 3 • 4.5 years	0.00% 0/60 • 4.5 years
Infections and infestations Upper respiratory tract infection	0.97% 2/207 • Number of events 2 • 4.5 years	3.4% 2/58 • Number of events 2 • 4.5 years	5.3% 3/57 • Number of events 3 • 4.5 years	3.5% 2/57 • Number of events 2 • 4.5 years	0.00% 0/60 • 4.5 years

Additional Information

Clinical Trial Disclosure Manager

CSL Behring

Phone: Use email contact

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER