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

NCT00099489 | Completed Phase 2

• 1 other identifier: C-870
• Study Type: interventional
• Target: 67
• Locations: 4 countries
• Sites: 20

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).

Conditions

Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Keywords

Chronic Inflammatory Demyelinating Polyradiculoneuropathy; CIDP; IVIg; AVONEX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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).

Interventions

Interferon Beta-1a DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent prior to any testing under this protocol
• Must be between 18 and 75 years of age
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (20)

Phoenix Neurological Associates, Ltd.

Phoenix, Arizona, 85006, United States

Location

Neuromuscular Research Center

Scottsdale, Arizona, 85258, United States

Location

University of Florida, Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

Harvard University/MGH

Boston, Massachusetts, 02114, United States

Location

Tufts University/ St. Elizabeths

Boston, Massachusetts, 02135, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Weill Medical College of Cornell University

New York, New York, 10022, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390-8897, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Institute of Clinical Neurosciences

Sydney, New South Wales, 2006, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

Montreal Neurological Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Guy's Hospital/Dept. of Neuroimmunology

London, SE1 1UL, United Kingdom

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Allan Ropper, MD

  Tufts University School of Medicine, St. Elizabeth's Medical Center

  PRINCIPAL INVESTIGATOR

• Kate Dawson, MD

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2004
• First Posted: December 16, 2004
• Study Start: February 1, 2004
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: March 5, 2010

Record last verified: 2010-03

Locations

AU (4); US (13); CA (2); GB (1)