Personalized extended interval dosing of natalizumab in relapsing remitting multiple sclerosis (NEXT-MS)
Phase 1
- Conditions
- Multiple SclerosisTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-513105-31-00
- Lead Sponsor
- Amsterdam UMC Stichting
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 440
Inclusion Criteria
Diagnosis of relapsing remitting multiple sclerosis according to the 2017 criteria, 6 or more consecutive natalizumab infusions, 18 years or older, Agreed to participate (written informed consent)
Exclusion Criteria
High titer natalizumab (>100AU/ml) antibodies, Contraindication for yearly magnetic resonance imaging (MRI) (ie, have pacemakers or other contraindicated implanted metal devices, or have claustrophobia that cannot be medically managed)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method