Trial record 6 of 22 for:    "Chronic inflammatory demyelinating polyneuropathy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by CSL Behring
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01545076
First received: March 1, 2012
Last updated: July 14, 2014
Last verified: July 2014
  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 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
Biological: Placebo
Biological: IgPro10
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

Resource links provided by NLM:


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 or withdrawal due to any other reason [ 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 ]
  • Change in mean Rasch-built Overall Disability Scale (R-ODS) scores during the SC Treatment Period [ Time Frame: SC week 1, SC week 25 ] [ Designated as safety issue: No ]
  • Time to improvement on IgPro10 Re-stabilization Therapy [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Improvement is defined as: an INCAT score decrease by 1 point, 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: Before and at the end of IgPro10 Re-stabilization Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in MRC sum score during IgPro10 Re-stabilization Therapy [ Time Frame: Before and at the end of IgPro10 Re-stabilization Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in R-ODS during IgPro10 Re-stabilization Therapy [ Time Frame: Before and at the end of IgPro10 Re-stabilization Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in INCAT during IgPro10 Re-stabilization Therapy [ Time Frame: Before and at the end of IgPro10 Re-stabilization Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in mean grip strength during IgPro10 Rescue Therapy [ Time Frame: Before and at the end of IgPro10 Rescue Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in MRC sum score during IgPro10 Rescue Therapy [ Time Frame: Before and at the end of IgPro10 Rescue Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in R-ODS during IgPro10 Rescue Therapy [ Time Frame: Before and at the end of IgPro10 Rescue Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Change in INCAT during IgPro10 Rescue Therapy [ Time Frame: Before and at the end of IgPro10 Rescue Therapy, up to 12 weeks ] [ Designated as safety issue: No ]
  • Time to improvement after CIDP relapse in the SC Treatment Period [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
    Improvement is defined as a decrease in INCAT score back to or below the baseline score

  • Time to improvement after CIDP relapse during IgPro10 Rescue Therapy [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
    Improvement is defined as a decrease in INCAT score back to or below the baseline score

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

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


Estimated Enrollment: 350
Study Start Date: March 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (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
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 IgPro20 Phase for subjects with a CIDP relapse.
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
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 IgPro20 Phase for subjects with a CIDP relapse.
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 IgPro20 Phase for subjects with a CIDP relapse.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Use Central Contact clinicaltrials@cslbehring.com

  Show 100 Study Locations
Sponsors and Collaborators
CSL Behring
ICON Clinical Research
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: July 14, 2014
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
Japan: Pharmaceuticals and Medical Devices 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:
Polyneuropathies
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014