Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
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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 |
- 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).
- 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 |
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| Contact: Use Central Contact | clinicaltrials@cslbehring.com |
Show 67 Study Locations| 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:
|
Polyneuropathies Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Demyelinating Diseases Polyradiculoneuropathy Autoimmune Diseases of the Nervous System Nervous System 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