OLERO · MN43964

Multicenter, open-label extension clinical trial seeking to evaluate the long-term efficacy and safety profile of the use of ocrelizumab in people with multiple sclerosis.

A multicenter, single-arm, open-label extension study evaluating the long-term safety and efficacy of ocrelizumab in patients with multiple sclerosis. EudraCT: 2021-005746-15.

Sponsor: ROCHE

Phase: III

Status: Follow-up

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Public study eligibility criteria

Inclusion

  • * Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
  • * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet

Exclusion

  • * Concurrent participation in any clinical trial (other than the Parent study)
  • * Unable or unwilling to comply with the requirements of the protocol