Status:
COMPLETED
Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Biogen
Collaborating Sponsors:
Elan Pharmaceuticals
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 Mul...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00097760
Start Date
June 1 2003
End Date
March 1 2004
Last Update
June 18 2009
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.