A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)
Active, not recruiting
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT05925049
- Lead Sponsor
- Biogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Key Inclusion Criteria:<br><br> - Participants who are natalizumab-naïve and other MS mAb-naive and who start on<br> natalizumab SC.<br><br> - Participants who have previously received natalizumab IV and switch from natalizumab<br> IV to SC administration.<br><br>Key Exclusion Criteria :<br><br> - For the natalizumab-naive and other MS mAb-naive cohort, participants who previously<br> received natalizumab or other MS mAbs will be excluded.<br><br> - For the natalizumab-experienced cohort, participants who are naive to natalizumab<br> will be excluded.<br><br>NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs)
- Secondary Outcome Measures
Name Time Method Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs);Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status;Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status