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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Po

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 Summary:

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.


Sponsor: Biogen

Current 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).

Original Primary Outcome: To examine the relationship between the overall weekly AVONEX dose and the time to disease progression (as defined by a 2-point decrease in the MRC sum score and a 1-point increase in the ODSS) from the time of IVIg withdrawal.

Current Secondary Outcome:

  • The time to disease progression.
  • Percentage reduction in IVIg dose (g/Kg).
  • The number of days between Visit 5 and either disease progression or Visit 9
  • (Week 32, End of Study).
  • The proportion of subjects with disease progression at Visit 9 (Week 32, End of Study).
  • The change in MRC sum score from baseline to the time of IVIg withdrawal.
  • Change from baseline to Visit 5 and to Visit 9 (Week 32, End of Study) in a composite score of maximal conduction velocity.


Original Secondary Outcome:

  • To determine whether AVONEX, when compared to placebo, delays the time to disease progression (as defined by a 2-point decrease in MRC sum score and a 1-point increase in the ODSS) from the time of IVIg withdrawal
  • To assess the clinical meaningfulness of changes in the MRC sum score by determining its correlation to the ODSS, the Rotterdam Handicap Scale, and the Subject's Global Assessment as measured by the VAS
  • To determine whether 15/16 weeks (IVIg scheduling dependent) of treatment with AVONEX improves muscle strength (as measured by the MRC sum score).


Information By: Biogen

Dates:
Date Received: December 15, 2004
Date Started: February 2004
Date Completion:
Last Updated: March 4, 2010
Last Verified: March 2010