Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00030966|
Recruitment Status : Completed
First Posted : February 18, 2002
Last Update Posted : June 18, 2009
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-Remitting||Drug: Natalizumab Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
Experimental: Group 1
Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
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.
Placebo monthly infusion for up to 116 weeks.
- 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 ]
- If this combination reduces MRI lesions and the overall rate of clinical relapses [ Time Frame: 1 year and 2 years ]
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
|Study Director:||Michael Panzara, MD, MPH||Biogen|
|Principal Investigator:||Richard A Rudick, MD||The Cleveland Clinic|