Status:
COMPLETED
Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Lead Sponsor:
Biogen
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Brief Summary
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).
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 12 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 2 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04832399
Start Date
November 12 2013
End Date
October 2 2023
Last Update
February 5 2024
Active Locations (18)
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1
Research Site
Amadora, Portugal, 2720-276
2
Research Site
Angra do Heroísmo, Portugal, 9700-049
3
Research Site
Aveiro, Portugal, 3810-164
4
Research Site
Braga, Portugal, 4710-243