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

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Roche

Status and phase

Active, not recruiting
Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: Ocrelizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03599245
MN39158
2017-004886-29 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

This is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the Roche P-trials. Participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.

Enrollment

1,500 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,500 participants in 1 patient group

Ocrelizumab
Experimental group
Description:
Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.
Treatment:
Drug: Ocrelizumab

Trial contacts and locations

162

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Central trial contact

Reference Study ID Number: MN39158 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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