Status:
COMPLETED
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 yea...
Detailed Description
This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to Week 48) is referr...
Eligibility Criteria
Inclusion
- Key
- Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005)
- Must have an EDSS score between 0.0 and 5.0.
- Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months
- Key
Exclusion
- Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- Pregnant or nursing women
- Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
1516 Patients enrolled
Trial Details
Trial ID
NCT00906399
Start Date
June 1 2009
End Date
October 1 2013
Last Update
September 19 2014
Active Locations (178)
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1
Research Site
Phoenix, Arizona, United States, 85013
2
Research Site
Ponte Vedra Beach, Florida, United States, 32082 4040
3
Research Site
Atlanta, Georgia, United States, 30327
4
Research Site
Des Moines, Iowa, United States, 50314