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Clinical Trials/EUCTR2017-004886-29-FR
EUCTR2017-004886-29-FRActive, not recruitingPhase 1

A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIA

F. Hoffmann-La Roche Ltd0 sites750 target enrollmentStarted: May 17, 2018Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
750
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •- Able to comply with the study protocol, in the investigator’s judgment
  • •- Completed the treatment period of Roche sponsored ocrelizumab Parent-trial (exception for female patients who were pregnant during CASTING / MA30005 study and are still in the safety follow up period) and who in the opinion of the investigator may benefit from treatment with ocrelizumab
  • •- Meet re-treatment criteria with ocrelizumab
  • •- For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 750
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •- Hypersensitivity to ocrelizumab or to any of its excipients
  • •- Patients 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
  • •- Patients who discontinued ocrelizumab, exemption made for treatment discontinuation because of pregnancy and breastfeeding and continued clinical study assessments

Investigators

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