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This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

NCT03599245

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Multiple Sclerosis

Interventions: Ocrelizumab

Countries: Argentina, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Denmark

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Signed Informed Consent Form
* Able to comply with the study protocol, in the investigator's judgment
* Completed the treatment period of Roche sponsored ocrelizumab P-trials

Exclusion Criteria:

* Hypersensitivity to ocrelizumab or to any of its excipients.
* Participantss in a severely immunocompromised state until the condition resolves.
* Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation.
* Existence of a contra-indication as per SmPC
* Prohibited concomitant medication as specified in protocol
* Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study
Locations (159)
  • Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Rosario, Argentina
  • Bruges, Belgium
  • Edegem, Belgium
  • La Louvière, Belgium
  • Liège, Belgium
  • Overpelt, Belgium
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, São Paulo, Brazil
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Vancouver, British Columbia, Canada
  • London, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Toronto, Ontario, Canada
  • Gatineau, Quebec, Canada
  • Greenfield Park, Quebec, Canada
  • Montreal, Quebec, Canada
  • Zagreb, Croatia
  • Brno, Czechia
  • Jihlava, Czechia
  • Prague, Czechia
  • Prague, Czechia
  • Aalborg, Denmark
  • Aarhus N, Denmark
  • Glostrup Municipality, Denmark
  • Odense C, Denmark
  • Sønderborg, Denmark
  • + 129 more on CT.gov