Safety and Efficacy of Avonex in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
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).
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Drug: Interferon Beta-1a
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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)|
- 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).
- 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.
|Study Start Date:||February 2004|
|Study Completion Date:||February 2006|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
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.
|United States, Arizona|
|Phoenix Neurological Associates, Ltd.|
|Phoenix, Arizona, United States, 85006|
|Neuromuscular Research Center|
|Scottsdale, Arizona, United States, 85258|
|United States, Florida|
|University of Florida, Jacksonville|
|Jacksonville, Florida, United States, 32209|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Kansas|
|University of Kansas|
|Kansas City, Kansas, United States, 66160|
|United States, Louisiana|
|Louisiana State University|
|New Orleans, Louisiana, United States, 70112|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02114|
|Tufts University/ St. Elizabeths|
|Boston, Massachusetts, United States, 02135|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10022|
|United States, North Carolina|
|Raleigh Neurology Associates|
|Raleigh, North Carolina, United States, 27607|
|United States, Texas|
|University of Texas Southwestern|
|Dallas, Texas, United States, 75390-8897|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Australia, New South Wales|
|Liverpool, New South Wales, Australia, 2170|
|Institute of Clinical Neurosciences|
|Sydney, New South Wales, Australia, 2006|
|St. Vincent's Hospital|
|Fitzroy, Victoria, Australia, 3065|
|Royal Melbourne Hospital|
|Parkville, Victoria, Australia, 3050|
|London Health Sciences Center|
|London, Ontario, Canada, N6A 5A5|
|Montreal Neurological Hospital|
|Montreal, Quebec, Canada, H3A 2B4|
|Guy's Hospital/Dept. of Neuroimmunology|
|London, United Kingdom, SE1 1UL|
|Principal Investigator:||Allan Ropper, MD||Tufts University School of Medicine, St. Elizabeth's Medical Center|
|Study Director:||Kate Dawson, MD||Biogen Idec|