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Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants

CompletedN/A

Sponsor: Biogen

Conditions: Relapsing Remitting Multiple Sclerosis

Interventions: Natalizumab

Countries: Portugal

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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.

Locations (18)

Amadora, Portugal
Angra do Heroísmo, Portugal
Aveiro, Portugal
Braga, Portugal
Coimbra, Portugal
Faro, Portugal
Funchal, Portugal
Guimarães, Portugal
Leiria, Portugal
Lisbon, Portugal
Loures, Portugal
Matosinhos Municipality, Portugal
Penafiel, Portugal
Porto, Portugal
Santa Maria da Feira, Portugal
Setúbal, Portugal
Viana do Castelo, Portugal
Vila Nova de Gaia, Portugal