Trial record 11 of 23 for:    Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00099489
First received: December 15, 2004
Last updated: March 4, 2010
Last verified: March 2010
  Purpose

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).


Condition Intervention Phase
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Drug: Interferon Beta-1a
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Estimated Enrollment: 67
Study Start Date: February 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099489

Locations
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
Harvard University/MGH
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 Hospital
Liverpool, New South Wales, Australia, 2170
Institute of Clinical Neurosciences
Sydney, New South Wales, Australia, 2006
Australia, Victoria
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Canada, Ontario
London Health Sciences Center
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal Neurological Hospital
Montreal, Quebec, Canada, H3A 2B4
United Kingdom
Guy's Hospital/Dept. of Neuroimmunology
London, United Kingdom, SE1 1UL
Sponsors and Collaborators
Biogen Idec
Investigators
Principal Investigator: Allan Ropper, MD Tufts University School of Medicine, St. Elizabeth's Medical Center
Study Director: Kate Dawson, MD Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Medical Director
ClinicalTrials.gov Identifier: NCT00099489     History of Changes
Other Study ID Numbers: C-870
Study First Received: December 15, 2004
Last Updated: March 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
CIDP
IVIg
AVONEX

Additional relevant MeSH terms:
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Demyelinating Diseases
Polyneuropathies
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta 1a
Interferon-beta
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on August 21, 2014