Status:
COMPLETED
Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to cha...
Eligibility Criteria
Inclusion
- Key inclusion Criteria:
- Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.
- A relapsing-remitting course of disease with at least 1 documented relapse during the previous year, or 2 documented relapses during the previous 2 years, or a positive gadolinium (Gd)-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a second scan may be obtained 1 month later.)
- An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at randomization.
- Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization.
- Patients who decline initiation or continuation of treatment with available disease modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.
- Key exclusion Criteria:
- A manifestation of another type of MS than RRMS
- History of chronic disease of the immune system other than MS
- Malignancies, diabetes, significant cardiovascular, pulmonary and hepatic diseases and conditions
- Active infections
Exclusion
Key Trial Info
Start Date :
March 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2011
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT00879658
Start Date
March 30 2009
End Date
May 4 2011
Last Update
January 13 2020
Active Locations (72)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Cullman, Alabama, United States, 35058
2
Novartis Investigative Site
San Francisco, California, United States, 94143
3
Novartis Investigative Site
Centennial, Colorado, United States, 80112
4
Novartis Investigative Site
Miami, Florida, United States, 33136