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Tysabri Observational Program
Tysabri Observational Program

NCT00493298

CompletedN/A

Sponsor: Biogen

Conditions: Relapsing-Remitting Multiple Sclerosis

Interventions: Tysabri

Countries: Argentina, Australia, Belgium, Brazil, Canada, Czechia, Finland, France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations (419)
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • CABA, Argentina
  • Córdoba, Argentina
  • Santa Fe, Argentina
  • Camperdown, New South Wales, Australia
  • Liverpool, New South Wales, Australia
  • New Lambton Heights, New South Wales, Australia
  • St Leonards, New South Wales, Australia
  • Auchenflower, Queensland, Australia
  • Gold Coast, Queensland, Australia
  • Adelaide, South Australia, Australia
  • North Adelaide, South Australia, Australia
  • Box Hill, Victoria, Australia
  • Fitzroy, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Parkville, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Aalst, Belgium
  • Anderlecht, Belgium
  • Antwerp, Belgium
  • Bocholt, Belgium
  • Brasschaat, Belgium
  • Bruges, Belgium
  • Brussels, Belgium
  • Brussels, Belgium
  • Charleroi, Belgium
  • + 389 more on CT.gov