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SELECT: Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis
NCT00390221Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2008
- Primary completion
- May 2011
- Countries
- 8
- Sponsor
- Biogen
- Modality
- Monoclonal Antibodies
- Drugs
- daclizumab
- Conditions
- relapsing-remitting multiple sclerosis (RRMS)
01
Overview
Phase 2, randomised, double-blind trial of daclizumab in relapsing-remitting multiple sclerosis (RRMS) (3 arms), sponsored by Biogen. Primary endpoint: Adjusted Annualized Relapse Rate at 52 weeks. Started Feb 2008; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo SC every 4 weeks
150 mg DAC HYP
150 mg Daclizumab HYP SC every 4 weeks
300 mg DAC HYP
300 mg Daclizumab HYP SC every 4 weeks
03
Who it enrols
Adult patients with Relapsing-Remitting Multiple Sclerosis (RRMS), EDSS 0.0-5.0, and recent relapse or Gd-enhancing lesions.
04
Endpoints
Primary
Adjusted Annualized Relapse Rate
Secondary
Number of New Gadolinium-Enhancing Lesions
Number of New or Newly-Enlarging T2 Hyperintense Lesions
Proportion of Participants Who Relapsed
Multiple Sclerosis Impact Scale-29 Physical Impact Score
05
Results
Primary endpoints met
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