CompletedN/AOther
Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Sponsored by Biogen
NCT ID
NCT04832399
Target Enrollment
60 participants
Start Date
2013-11-12
Est. Completion
2023-10-02
About This Study
The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS).
Conditions Studied
Interventions
- •Natalizumab
Eligibility
Age:18 Years - 55 Years
Healthy Volunteers:No
View full eligibility criteria
Key Inclusion Criteria: * Documented diagnosis of Relapsing Remitting Multiple Sclerosis (McDonald 2010 Criteria). * EDSS ≤ 3.0. * Must fulfill Tysabri indication (relapse and MRI criteria). * Decision to start treatment with Natalizumab must precede enrollment. * Up to four natalizumab infusions. Key Exclusion Criteria: * Any prior treatment with Natalizumab. * Prior imunossupressive treatment (Mitoxantrone, Azathioprine, Methotrexate, Cyclophosphamide, Mycophenolate, Cladribine, Rituximab). * Contraindications to treatment with Natalizumab. * History of Progressive Multifocal Leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections. * Immunocompromised at the time of enrollment. Known active malignancies. * Inability to comply with study requirements. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations (18)
Research Site
Amadora, Portugal
Research Site
Angra do Heroísmo, Portugal
Research Site
Aveiro, Portugal
Research Site
Braga, Portugal
Research Site
Coimbra, Portugal
Research Site
Faro, Portugal
Research Site
Funchal, Portugal
Research Site
Guimarães, Portugal
Research Site
Leiria, Portugal
Research Site
Lisbon, Portugal
+8 more locations