A Multicenter Randomized Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects (REVEAL).
The purpose of this study is to assess the impact of natalizumab (Tysabri) versus fingolimod (Gilenya) on CNS tissue damage and recovery in active RRMS subjects. Subjects will be randomized 1:1 to receive either open-label natalizumab 300 mg IV every 4 weeks to Week 52 (last infusion at Week 52) or fingolimod 0.5 mg once daily orally for 52 weeks (last capsule at Week 52).
January 01, 1900
Neuroscience - Multiple Sclerosis,
Peiqing Qian, MD
Key Inclusion Criteria:
- Age 18-60 years old, inclusive, at the time of informed consent.
- Must have a documented diagnosis of relapsing MS (McDonald 2010 Criteria at study screening.
- If subject is on BRACE therapy at screening, he/she must have been on therapy for at least 12 months, have at least 9 T2-Hyerintensivie lesions on a brain MRI scan and experience >1 relapse within the last 6 months with >1 new T1-Gd+ lesion or >2 new T2 lesions on a brain MRI scan.
- If subject is DMT na�ve at screening, he/she must have experienced >2 disabling relapses in the last 12 months and have had >1 new T1-Gd+ lesion or >2 new T2 lesions on a brain MRI scan.
Key Exclusion Criteria:
- Prior treatment with Tysabri or Gilenya
- Diagnosis of Primary Progressive MS and/or Secondary Progressive MS
- History of opportunistic infections (including PML) or any clinically significant dise...
Caryl Tongco (or Yuriko Courtney)