TOP: TYSABRI Observational Program

CompletadoClinicalTrials.gov

ID: NCT00493298Tipo: OBSERVATIONALInicio: 29 de jun de 2007Fin estimado: 1 de nov de 2023

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of Tysabri in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

Descripción detallada

TOP is an epidemiological observational study of participants receiving natalizumab, with each participant to be followed for up to 15 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use, and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Documented diagnosis of Relapsing Remitting Multiple Sclerosis
The decision to treat with Tysabri must precede enrollment
Patient must be a new Tysabri user, and must not have had more than 3 Tysabri infusions prior to enrollment
Must have had at least one relapse in the previous year, and must satisfy locally approved therapeutic indications for Tysabri

Criterios de exclusión

History of Progressive Multifocal Leukoencephalopathy or other opportunistic infections, or an increased risk of opportunistic infections
History of positive anti-Tysabri antibodies
Concomitant Immunomodulatory or immunosuppressive therapy during therapy with Tysabri
Patient immunocompromised at the time of enrollment
Known active malignancy
Women must not be breast feeding or pregnant, or planning to become pregnant (must use birth control unless surgically sterile)

Intervenciones

drug

Tysabri

According to the local prescribing information

Ubicaciones

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

Buenos Aires, Argentina

Research Site

CABA, Argentina

Research Site

Córdoba, Argentina

Research site

Santa Fe, Argentina

Patrocinadores

PrincipalBiogen

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