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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00030966 |
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Date of registration:
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15/02/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
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Scientific title:
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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 |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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1200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00030966 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Belgium
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France
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Germany
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Israel
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Italy
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United States
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Contacts
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Name:
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Michael Panzara, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen Idec |
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Name:
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Richard A Rudick, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Cleveland Clinic |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Relapsing-Remitting
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Intervention(s)
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Drug: Placebo
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Drug: Natalizumab
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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If this combination reduces MRI lesions and the overall rate of clinical relapses
[Time Frame: 1 year and 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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