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

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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Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period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