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
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|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 ]
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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|
Publications of Results:
|Responsible Party:||Biogen Idec MD, Biogen Idec|
|Other Study ID Numbers:||
|First Posted:||February 18, 2002 Key Record Dates|
|Last Update Posted:||June 18, 2009|
|Last Verified:||June 2009|
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Physiological Effects of Drugs