Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) - Full Text View

Purpose

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 on intravenous immunoglobulin (IVIG) maintenance therapy enrolled in the study will be assessed during 3 separate study periods. Patients first undergo an IVIG Withdrawal Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during the withdrawal period will be administered IVIG 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 INCAT score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.

Condition	Intervention	Phase
Chronic Inflammatory Demyelinating Polyneuropathy Polyradiculoneuropathy	Biological: IgPro20 Biological: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by CSL Behring:

Primary Outcome Measures:

Percentage (%) of subjects who relapse during the SC treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
Change in mean maximum grip strength scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
Change in mean Medical Research Council (MRC) sum scores during the SC treatment period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
Time to CIDP relapse [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
Rate of adverse events per SC infusion [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Number of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Percentage of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	March 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: IgPro20 low dose	Biological: IgPro20 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) 0.4 g/kg body weight (high dose arm) Other Name: Hizentra
Experimental: IgPro20 high dose	Biological: IgPro20 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) 0.4 g/kg body weight (high dose arm) Other Name: Hizentra
Placebo Comparator: Placebo	Biological: Placebo 2% human albumin administered by weekly SC infusions during the SC treatment period of the study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
Repeated treatment with IVIG (≥ 4 infusions) within the last 9 months prior to enrollment.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545076

Contacts

Contact: Use Central Contact

clinicaltrials@cslbehring.com

Hide Study Locations

Locations

United States, Alabama
Site reference 8400181	Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Site reference 8400172	Recruiting
Phoenix, Arizona, United States, 85018
Site reference 8400173	Recruiting
Phoenix, Arizona, United States, 85013
United States, California
Site reference 8400167	Recruiting
Los Angeles, California, United States, 90033
United States, Colorado
Site reference 8400077	Recruiting
Centennial, Colorado, United States, 80112
United States, Florida
Site reference 8400165	Recruiting
Jacksonville, Florida, United States, 32209
United States, Illinois
Site reference 8400162	Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
Site reference 8400166	Recruiting
Kansas City, Kansas, United States, 66160
United States, New York
Site reference 8400207	Recruiting
New York, New York, United States, 10032
Site reference 8400169	Recruiting
New York, New York, United States, 10021
Site reference 8400179	Recruiting
New York, New York, United States, 10021
United States, North Carolina
Site reference 8400182	Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
Site reference 8400178	Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
Site reference 8400164	Recruiting
Houston, Texas, United States, 77030
Australia, Victoria
Site reference 0360011	Recruiting
Fitzroy, Victoria, Australia
Australia
Site reference 0360008	Recruiting
Southport, Australia
Austria
Site reference 0400009	Recruiting
Innsbruck, Austria
Site reference 0400010	Withdrawn
Senftenberg, Austria
Belgium
Site reference 0560003	Recruiting
Leuven, Belgium
Canada
Site reference 1240018	Recruiting
Calgary, Canada
Site reference 1240010	Recruiting
Montreal, Canada
Site reference 1240007	Recruiting
Quebec, Canada
Site reference 1240009	Recruiting
Toronto, Canada
Czech Republic
Site reference 2030003	Recruiting
Prague, Czech Republic
Finland
Site reference 2460002	Recruiting
Helsinki, Finland
Site reference 2460004	Recruiting
Tampere, Finland
France
Site reference 2500024	Recruiting
Clermont-Ferrand, France
Site reference 2500013	Recruiting
Marseille, France
Site reference 2500021	Recruiting
Nancy, France
Site reference 2500022	Recruiting
Nice, France
Site reference 2500019	Recruiting
Pessac, France
Germany
Site reference 2760069	Recruiting
Berlin, Germany
Site reference 2760072	Recruiting
Berlin, Germany
Site reference 2760048	Recruiting
Berlin, Germany
Site reference 2760049	Recruiting
Bochum, Germany
Site reference 2760075	Recruiting
Duesseldorf, Germany
Site reference 2760052	Recruiting
Essen, Germany
Site reference 2760036	Recruiting
Goettingen, Germany
Site reference 2760053	Recruiting
Goettingen, Germany
Site reference 2760054	Recruiting
Hannover, Germany
Site reference 2760055	Recruiting
Leipzig, Germany
Site reference 2760073	Recruiting
Marburg, Germany
Site reference 2760057	Recruiting
Muenster, Germany
Site reference 2760047	Recruiting
Potsdam, Germany
Site reference 2760039	Recruiting
Wuerzburg, Germany
Israel
Site reference 3760005	Recruiting
Haifa, Israel
Italy
Site reference 3800026	Recruiting
Chieti, Italy
Site reference 3800027	Recruiting
Firenze, Italy
Site reference 3800028	Recruiting
Genova, Italy
Site reference 3800029	Recruiting
La Spezia, Italy
Site reference 3800031	Recruiting
Milano, Italy
Site reference 3800032	Recruiting
Milano, Italy
Site reference 3800041	Recruiting
Monza, Italy
Site reference 3800034	Recruiting
Novara, Italy
Site reference 3800036	Recruiting
Roma, Italy
Site reference 3800030	Recruiting
Rozzano (Milano), Italy
Site reference 3800037	Recruiting
Torino, Italy
Netherlands
Site reference 5280001	Recruiting
Amsterdam, Netherlands
Site reference 5280005	Recruiting
Maastricht, Netherlands
Site reference 5280004	Recruiting
Utrecht, Netherlands
Spain
Site reference 7240011	Recruiting
Barcelona, Spain
Site reference 7240010	Recruiting
Barcelona, Spain
Site reference 7240014	Recruiting
Madrid, Spain
Site reference 7240013	Recruiting
Madrid, Spain
Site reference 7240016	Recruiting
Sevilla, Spain
Site reference 7240017	Recruiting
Valencia, Spain
United Kingdom
Site reference 8260019	Recruiting
London, United Kingdom

Sponsors and Collaborators

CSL Behring

Parexel

Investigators

Principal Investigator:

Prof. Dr. Ivo N. van Schaik

Academic Medical Center, University of Amsterdam

More Information

No publications provided

Responsible Party:	CSL Behring
ClinicalTrials.gov Identifier:	NCT01545076 History of Changes
Other Study ID Numbers:	IgPro20_3003
Study First Received:	March 1, 2012
Last Updated:	March 23, 2013
Health Authority:	Australia: Human Research Ethics Committee Austria: Austrian Medicines and Medical Devices Agency Belgium: Ministry of Social Affairs, Public Health and the Environment Canada: Health Canada Czech Republic: State Institute for Drug Control Finland: Ministry of Social Affairs and Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Paul-Ehrlich-Institut Israel: Ministry of Health Italy: The Italian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Additional relevant MeSH terms:

Polyradiculoneuropathy
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013