Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
NCT ID: NCT04832399
Last Updated: 2024-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2013-11-12
2023-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Natalizumab
Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks.
Natalizumab
As described in the treatment arm.
Interventions
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Natalizumab
As described in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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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
Research Site
Loures, , Portugal
Research Site
Matosinhos Municipality, , Portugal
Research Site
Penafiel, , Portugal
Research Site
Porto, , Portugal
Research Site
Santa Maria da Feira, , Portugal
Research Site
Setúbal, , Portugal
Research Site
Viana do Castelo, , Portugal
Research Site
Vila Nova de Gaia, , Portugal
Countries
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Other Identifiers
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PRT-TYS-12-10409
Identifier Type: -
Identifier Source: org_study_id
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