A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients with Multiple Sclerosis

A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis - OLERO (Open-Label Extension Roll Over)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005746-15-EE

Enrollment

1107

Registered

2022-02-17

Start date

2022-08-05

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Progressive Multiple Sclerosis (PPMS) Relapsing Multiple Sclerosis (RMS) MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ocrelizumab CAS Number: 637334-45-3

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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 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 1033 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 74

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies;Secondary Objective: To evaluate the longer-term efficacy of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies;Primary end point(s): 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0);Timepoint(s) of evaluation of this end point: 1. Up to approximately 8 years	—

Measure

Time frame

Main Objective: To evaluate the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies;Secondary Objective: To evaluate the longer-term efficacy of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies;Primary end point(s): 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0);Timepoint(s) of evaluation of this end point: 1. Up to approximately 8 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change in Expanded Disability Status Scale (EDSS) score over time 2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time 3. The number of new, hypointense T1 lesions and number of new or enlarging T2 lesions 4. The change in total volume of T2 lesions and in total T1 lesion volume ;Timepoint(s) of evaluation of this end point: 1-4. Week 0, 24, 48, 72, 96n where n= number (multiple of 24).	—

Measure

Time frame

Secondary end point(s): 1. Change in Expanded Disability Status Scale (EDSS) score over time 2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time 3. The number of new, hypointense T1 lesions and number of new or enlarging T2 lesions 4. The change in total volume of T2 lesions and in total T1 lesion volume ;Timepoint(s) of evaluation of this end point: 1-4. Week 0, 24, 48, 72, 96n where n= number (multiple of 24).

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Countries

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Croatia, Czechia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026