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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01545076
First Posted: March 6, 2012
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
CSL Behring
  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 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 Intervention Phase
Chronic Inflammatory Demyelinating Polyneuropathy Polyradiculoneuropathy Biological: IgPro20 (low dose) Biological: Placebo Biological: IgPro10 Biological: IgPro20 (high dose) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Percentage (%) of subjects who relapse or are withdrawn for any other reason during the SC treatment period [ Time Frame: 24 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).


Secondary Outcome Measures:
  • Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period [ Time Frame: At baseline and at all visits during the 25-week SC Treatment Period ]
  • Change in mean maximum grip strength scores during the SC treatment period [ Time Frame: At baseline and at all visits during the 25-week SC Treatment Period ]
  • Change in mean Medical Research Council (MRC) sum scores during the SC treatment period [ Time Frame: At baseline and at all visits during the 25-week SC Treatment Period ]
  • Time to CIDP relapse or withdrawal due to any other reason [ Time Frame: up to 24 weeks ]
  • Rate of adverse events per SC infusion [ Time Frame: 24 weeks ]
  • Number of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ]
  • Percentage of subjects with adverse events during the SC Treatment Period [ Time Frame: 24 weeks ]
  • Change in mean Rasch-built Overall Disability Scale (R-ODS) scores during the SC Treatment Period [ Time Frame: At baseline and at all visits during the 25-week SC Treatment Period ]
  • Time to improvement on IgPro10 Re-stabilization Therapy [ Time Frame: Up to 12 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, or Mean Grip strength improvement by at least 8 kPa in one hand.

  • Change in mean grip strength during IgPro10 Re-stabilization Therapy [ Time Frame: During IgPro10 Re-stabilization Therapy, up to 12 weeks ]
  • Change in MRC sum score during IgPro10 Re-stabilization Therapy [ Time Frame: During IgPro10 Re-stabilization Therapy, up to 12 weeks ]
  • Change in R-ODS during IgPro10 Re-stabilization Therapy [ Time Frame: During IgPro10 Re-stabilization Therapy, up to 12 weeks ]
  • Change in INCAT during IgPro10 Re-stabilization Therapy [ Time Frame: During IgPro10 Re-stabilization Therapy, up to 12 weeks ]
  • Change in mean grip strength during IgPro10 Rescue Therapy [ Time Frame: During IgPro10 Rescue Therapy, up to 12 weeks ]
  • Change in MRC sum score during IgPro10 Rescue Therapy [ Time Frame: During IgPro10 Rescue Therapy, up to 12 weeks ]
  • Change in R-ODS during IgPro10 Rescue Therapy [ Time Frame: During IgPro10 Rescue Therapy, up to 12 weeks ]
  • Change in INCAT during IgPro10 Rescue Therapy [ Time Frame: During IgPro10 Rescue Therapy, up to 12 weeks ]
  • Time to improvement after CIDP relapse in the SC Treatment Period [ Time Frame: Up to 24 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

  • Time to improvement after CIDP relapse during IgPro10 Rescue Therapy [ Time Frame: Up to 12 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

  • Rate of adverse events per IgPro10 infusion [ Time Frame: 24 weeks ]
  • Number of subjects with adverse events - IgPro10 [ Time Frame: Up to 13 weeks ]
    During IgPro10 Re-stabilization or Rescue Therapy

  • Percentage of subjects with adverse events - IgPro10 [ Time Frame: Up to 13 weeks ]
    During IgPro10 Re-stabilization or Rescue Therapy


Enrollment: 172
Study Start Date: March 2012
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545076


  Show 91 Study Locations
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)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01545076     History of Changes
Other Study ID Numbers: IgPro20_3003
First Submitted: March 1, 2012
First Posted: March 6, 2012
Last Update Posted: October 2, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Polyneuropathies
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Polyradiculoneuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs