Trial · NCT02027701

Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT02027701, Phase 3, Completed, CSL Behring; results first posted 2018-10-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Trials, record NCT02027701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02027701

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT number: NCT02027701
Status: Completed
Phases: Phase 3
Enrollment: 82 participants, actual
Lead sponsor: CSL Behring
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Interventions: IgPro20
First posted: 2014-01-06
Last updated: 2018-10-02
Other registries' IDs: eudract:2013-004157-24
Results first posted: 2018-10-02

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Adverse Events (AEs) Per Infusion	Up to 49 weeks
Secondary	Time to First CIDP Relapse	Up to 49 weeks	Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. 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 only).
Secondary	Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score	Baseline and up to 49 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.
Secondary	Change From Baseline in Medical Research Council (MRC) Score	Baseline and up to 49 weeks	An adapted version of the MRC sum score as published by Kleyweg and the RMC trial group was used. With the MRC sum score, the following 8 bilateral muscle pairs were assessed, and individual muscle scores as well as the sum score documented: Shoulder abduction; Elbow flexion; Wrist extension; Index finger abduction; Hip flexion; Knee extension; Foot dorsiflexion; Great toe dorsiflexion. The MRC sum score ranges from 0 (paralysis) to 80 (normal strength) points.
Secondary	Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)	Baseline and up to 49 weeks	The R-ODS is a recently published outcome measure that captures activity and social participation in subjects with Guillain-Barré Syndrome, CIDP, and monoclonal gammopathy of uncertain significance. The 24-item questionnaire covers a wide range of tasks of daily life that are each to be rated as "impossible to perform", "able to perform with difficulty", or "easy to perform" (scale of 0 - 2 points respectively). Items are sorted in order of increasing difficulty to perform, based on data from subjects with peripheral neuropathies (chronic inflammatory demyelinating polyneuropathy, Guillain-Barré Syndrome, or monoclonal gammopathy of uncertain significance) and subjects recruited at the university outpatient clinics of Rotterdam and Maastricht.
Secondary	Change From Baseline in Mean Grip Strength	Baseline and up to 49 weeks	The hand-held Vigorimeter from Martin (Tuttlingen, Germany) is a device that measures the strength of small muscles in the hand, ie, grip strength. The subject squeezes a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure is recorded via a rubber tube on a nanometer and expressed in kilopascal (kPa). At each assessment, the subject squeezes 3 times with each hand.
Secondary	Percentage of Subjects With Adverse Events (AEs)	Up to 49 weeks
Secondary	Number of AEs by Severity Per Infusion	Up to 49 weeks
Secondary	Percentage of Subjects With AEs by Severity	Up to 49 weeks
Secondary	Number of Causally Related AEs Per Infusion	Up to 49 weeks

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Adverse Events (AEs) Per Infusion	Up to 49 weeks	Safety Data Set (SDS): all subjects who received at least 1 dose of IgPro20 in this study.	Adverse events per infusion	NUMBER
SECONDARY	Time to First CIDP Relapse	Up to 49 weeks	Total Set: all subjects enrolled in the study, ie, the subject's informed consent was obtained. In the study protocol, this analysis set was referred to as the Intention-to-Treat Data Set.	Days	MEDIAN
SECONDARY	Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score	Baseline and up to 49 weeks	Total Set	units on a scale	MEDIAN
SECONDARY	Change From Baseline in Medical Research Council (MRC) Score	Baseline and up to 49 weeks	Total Set	units on a scale	MEDIAN
SECONDARY	Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)	Baseline and up to 49 weeks	Total Set	units on a scale	MEDIAN
SECONDARY	Change From Baseline in Mean Grip Strength	Baseline and up to 49 weeks	Total Set	kPa	MEDIAN
SECONDARY	Percentage of Subjects With Adverse Events (AEs)	Up to 49 weeks	SDS	percentage of subjects	NUMBER
SECONDARY	Number of AEs by Severity Per Infusion	Up to 49 weeks	SDS	Adverse events per infusion	NUMBER
SECONDARY	Percentage of Subjects With AEs by Severity	Up to 49 weeks	SDS	percentage of subjects	NUMBER
SECONDARY	Number of Causally Related AEs Per Infusion	Up to 49 weeks	SDS	Adverse events per infusion	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group17

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Adverse Events (AEs) Per Infusion	IgPro20		0.032		Adverse events per infusion
Time to First CIDP Relapse	IgPro20		266.0	95% Confidence Interval 225.0 to NA	Days
Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score	IgPro20		0.0	Full Range -3 to 6	units on a scale
Change From Baseline in Medical Research Council (MRC) Score	IgPro20		0.0	Full Range -23 to 18	units on a scale
Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)	IgPro20		0.0	Full Range -76 to 33	units on a scale
Change From Baseline in Mean Grip Strength	IgPro20		-0.7	Full Range -80 to 27	kPa
Percentage of Subjects With Adverse Events (AEs)	IgPro20		75.6		percentage of subjects
Number of AEs by Severity Per Infusion	IgPro20	Mild	0.024		Adverse events per infusion
Number of AEs by Severity Per Infusion	IgPro20	Moderate	0.006		Adverse events per infusion
Number of AEs by Severity Per Infusion	IgPro20	Severe	0.002		Adverse events per infusion

1 to 10 of 17Source ClinicalTrials.gov

See all 17 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	IgPro20	82
Overall Study	COMPLETED	IgPro20	66
Overall Study	NOT COMPLETED	IgPro20	16

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Infusion site swelling	Skin and subcutaneous tissue disorders	IgPro20	9	82	11
other	Infusion site erythema	Skin and subcutaneous tissue disorders	IgPro20	7	82	9
other	Infusion site swelling	Skin and subcutaneous tissue disorders	IgPro20	9	82	11
other	Infusion Site erythema	Skin and subcutaneous tissue disorders	IgPro20	7	82	9
other	Nasopharyngitis	Infections and infestations	IgPro20	11	82	13
other	Headache	Nervous system disorders	IgPro20	4	82	5
serious	Gallbladder Perforation	Hepatobiliary disorders	IgPro20	1	82	1
serious	Atrial Flutter	Cardiac disorders	IgPro20	2	82	2
serious	Nerve Compression	Nervous system disorders	IgPro20	1	82	1
serious	Pulmonary Sepsis	Respiratory, thoracic and mediastinal disorders	IgPro20	1	82	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	IgPro20	0	82
Total, other adverse events	IgPro20	25	82
Total, serious adverse events	IgPro20	7	82

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02027701

GET https://conductscience.org/api/trials/v1/NCT02027701/registered

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