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Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030966
Recruitment Status : Completed
First Posted : February 18, 2002
Last Update Posted : June 18, 2009
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen

Study Description
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Brief Summary:
The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Natalizumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
Study Start Date : January 2002
Actual Primary Completion Date : April 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
 Drug: Natalizumab
Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
Other Name: Tysabri
Placebo Comparator: Group 2
Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
 Drug: Placebo
Placebo monthly infusion for up to 116 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. [ Time Frame: 1 year and 2 years ]

Secondary Outcome Measures :
  1. If this combination reduces MRI lesions and the overall rate of clinical relapses [ Time Frame: 1 year and 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4
  • Between the ages of 18 and 55, inclusive
  • Baseline EDSS score between 0.0 and 5.0, inclusive
  • Have been treated with Avonex for at least the 12 months prior to randomization
  • Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
  • Cranial MRI scan demonstrating lesions consistent with MS.
  • Have given written informed consent to participate in the study.

Exclusion Criteria:

  • Primary progressive, secondary progressive, or progressive relapsing MS.
  • MS relapse has occurred within 50 days of randomization
  • A clinically significant infectious illness within 30 days prior to randomization
  • History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks.
  • History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
  • Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3
  • Abnormal blood tests at Screening Visit
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030966


Locations
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Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
Investigators
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Study Director: Michael Panzara, MD, MPH Biogen
Principal Investigator: Richard A Rudick, MD The Cleveland Clinic
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00030966    
Other Study ID Numbers: C-1802
First Posted: February 18, 2002    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009
Keywords provided by Biogen:
Multiple Sclerosis
MS
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs