Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

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Brief Title

Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of AVONEX When Used in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Brief Summary

      The purpose of this study is to determine whether AVONEX (Interferon Beta-1a), when compared
      to placebo, reduces the total dose of IVIg that is administered after Visit 5 and through
      Visit 9 (Week 32, End of Study).
    

Detailed Description

      Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired peripheral
      neuropathy of unknown origin. The etiology is not well understood but is presumed to be
      immunological. Evidence for this comes from observed similarities to Guillain-Barre syndrome
      and from the favorable response with immunomodulatory treatments.

      CIDP is a peripheral nervous system demyelinating neuropathy that is sometimes a corollary
      disorder to the central nervous system demyelination of multiple sclerosis (MS. The precise
      mechanisms underlying the pathogenesis are uncertain, but a number of those mechanisms
      support a potential role for immunomodulatory treatments such as interferon beta (e.g.,
      Biogen Idec Inc.'s AVONEX).

      The rationale for the use of AVONEX in CIDP derives from observations on the pathogenesis of
      the condition and its similarities to MS, the mechanism of action of AVONEX, clinical trials
      that have been performed in CIDP that support a role for IFN-beta, and the unmet need that
      currently exists because of availability and safety issues with existing therapies.

      This Phase 2b study is a dose-ranging study designed to provide scientific evidence regarding
      the safety and efficacy of AVONEX in CIDP. In addition, the study aims to demonstrate the
      responsiveness and clinical relevance of changes in the MRC sum score and ODSS in CIDP
      patients.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

The primary endpoint for the efficacy analyses is the total IVIg dose (g/Kg) administered after Visit 5 and through Visit 9 (Week 32, End of Study).

Secondary Outcome

 The time to disease progression.

Condition

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Intervention

Interferon Beta-1a


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

Drug

Estimated Enrollment

67

Start Date

February 2004

Completion Date

February 2006

Primary Completion Date

February 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Written informed consent prior to any testing under this protocol

          -  Must be between 18 and 75 years of age

          -  Have a diagnosis of CIDP as determined by a board-certified or board-eligible
             neurologist, or equivalent, for at least 6 months, including fulfilling modified INCAT
             neurophysiological criteria for CIDP,CIDP motor deficit responsive to IVIg and
             alternative EP data that justifies subject inclusion, and/or supportive pathologic or
             laboratory data that supports the diagnosis of CIDP

          -  Documentation in the medical record prior to screening that the CIDP had been
             associated with loss of muscle strength, such that the MRC sum score was less than or
             equal to 58.

          -  Documentation in the medical record that the patient benefited fom IVIg treatment
             (patient had a 2-point change or equivalent in 60-point MRC sum score)

          -  Tested for IgM monoclonal gammopathy and found to have tested negative for IgM
             monoclonal gammopathy or if positive for IgM monoclonal gammopathy, then are MAG
             antibody-negative and proven to be IVI g responsive per protocol.

          -  Must have been clinically stable while on a constant regimen of IVIg (every 2-weeks,
             3-weeks, 4-weeks or 5-weeks) in the 3 months prior to screening.

        Exclusion Criteria*:

          -  Associated systemic disorder that might cause neuropathy.

          -  History of, or abnormal laboratory results indicative of any significant major disease
             or known drug hypersensitivity that, in the opinion of the investigator, would
             preclude the administration if IFN-beta or participation in this study.

          -  Subjects with diabetes mellitus will not be eligible, unless they satisfy both of the
             following requirements: a) their diabetes is well-controlled, with no retinopathy or
             nephropathy, having been identified during the ongoing care of their diabetes; and b)
             they have a normal sensory nerve action potential (SNAP) amplitude recorded in the
             sural nerve on at least one side of the body identified during electrophysiology (EP)
             testing documented in their medical record.

          -  Abnormal screening or baseline blood tests that the investigator deems clinically
             significant

          -  History of a seizure disorder prior to baseline (Visit 1, Week 0).

          -  History of suicidal ideation within 3 months prior to Baseline Visit (Week 0) or an
             episode of severe depression within 3 months prior to Baseline Visit (Week 0).

          -  Pure motor syndrome fulfilling criteria for multifocal motor neuropathy with
             conduction block.

          -  Pure sensory CIDP, or any other variant of CIDP without motor involvement

          -  Serious local infection or systemic infection within the 6 months prior to Screening.

          -  Use of IFN-beta at any time, use of plasma exchange, plasmapheresis, or any other
             immunosuppressant (with the exception of oral or non-systemic corticosteroids) within
             6 months prior to Screening.

          -  History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and/or
             aspirin that would preclude use of at least one of these during the study.

          -  For female subjects, unless postmenopausal or surgically sterile, unwillingness to
             practice effective contraception, as defined by the Investigator, during the study.

          -  Female subjects considering becoming pregnant while in the study

          -  Female subjects who are currently pregnant or breast-feeding.

               -  This list is not exhaustive and there may be additional exclusions
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Allan Ropper, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00099489

Organization ID

C-870



Study Sponsor

Biogen


Study Sponsor

Allan Ropper, MD, Principal Investigator, Tufts University School of Medicine, St. Elizabeth's Medical Center


Verification Date

March 2010