Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis: a randomized controlled trial
Phase 4
Recruiting
- Conditions
- MS10012303
- Registration Number
- NL-OMON52141
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 296
Inclusion Criteria
multiple sclerosis
minimally 48 weeks of treatment with ocrelizumab
Exclusion Criteria
age below 18
inability to undergo frequent MRIs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Relapses and new/enlarging T2 lesions on MRI.</p><br>
- Secondary Outcome Measures
Name Time Method <p>confirmed disability progression on the EDSS<br /><br>disability scores on the MSFC<br /><br>neurofilament light<br /><br>quality of life<br /><br>burden of treatment<br /><br>wearing-off effect<br /><br>IgG levels<br /><br>(serious) adverse events</p><br>