Brief Title
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)
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
Brief Summary
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period
Secondary Outcome
Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period
Condition
Chronic Inflammatory Demyelinating Polyneuropathy
Intervention
IgPro20 (low dose)
Study Arms / Comparison Groups
IgPro20 low dose
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
208
Start Date
March 2012
Completion Date
September 2016
Primary Completion Date
September 2016
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Prof. Dr. Ivo N. van Schaik, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01545076
Organization ID
IgPro20_3003
Responsible Party
Sponsor
Study Sponsor
CSL Behring
Collaborators
ICON Clinical Research
Study Sponsor
Prof. Dr. Ivo N. van Schaik, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date
December 2016