Back to resultsNatalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Natalizumab
Natalizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple Sclerosis, MS
Eligibility 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 GA for at least the 12 months prior to randomization Exclusion Criteria: Primary progressive, secondary progressive or progressive relapsing MS MS relapse has occurred within the 50 days prior to randomization A clinically significant infectious illness History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Arm Description
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Outcomes
Primary Outcome Measures
Rate of development of new active lesions on MRI scans.
Secondary Outcome Measures
Incidence and severity of adverse events.
Full Information
NCT ID
NCT00097760
First Posted
November 30, 2004
Last Updated
June 17, 2009
Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00097760
Brief Title
Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
Official Title
Safety Study of Natalizumab in Combination With Glatiramer Acetate (GA)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple Sclerosis, MS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Natalizumab
Other Intervention Name(s)
Tysabri
Intervention Description
Natalizumab 300 mg, IV infusion, every 4 weeks in addition to 20 mg of glatiramer acetate SC, daily, for up to 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Natalizumab
Other Intervention Name(s)
Tysabri
Intervention Description
Natalizumab, 300 mg IV infusion, every 4 weeks for up to 20 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, by IV infusion, every 4 weeks in addition to 20 mg glatiramer acetate, by SC injection, daily, for up to 20 weeks.
Primary Outcome Measure Information:
Title
Rate of development of new active lesions on MRI scans.
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events.
Time Frame
Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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 GA for at least the 12 months prior to randomization
Exclusion Criteria:
Primary progressive, secondary progressive or progressive relapsing MS
MS relapse has occurred within the 50 days prior to randomization
A clinically significant infectious illness
History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biogen Idec, MD
Organizational Affiliation
Biogen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.nationalmssociety.org
Description
The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.
URL
http://www.msactivesource.com
Description
MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen.
Learn more about this trial
Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
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