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

Phase 3

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: Ocrelizumab

• Registration Number: NCT05269004
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-07
• Study Start: 2022-05-03
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-24
• Last Update Posted: 2025-09-25
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ocrelizumab	Ocrelizumab	Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046). Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0	Up to 44 months

Secondary Outcome Measures

Name	Time	Method
The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume	Week 0, 24, 48, 72, 96, 120, 168
Change in 9-Hole Peg Test (9HPT) over time	Week 0, 24, 48, 72, 96, 120, 168
The number of T1 lesions and number of new or enlarging T2 lesions	Week 0, 24, 48, 72, 96, 120, 168
Change in Timed 25-Foot Walk Test (T25FWT) over time	Week 0, 24, 48, 72, 96, 120, 168
Change in Expanded Disability Status Scale (EDSS) score over time	Week 0, 24, 48, 72, 96, 120, 168

Trial Locations

Locations (234)

Hospital So Lucas da PUCRS; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

Klinikum Bayreuth GmbH; 🇩🇪 Bayreuth, Bavaria, Germany

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Liguria, Italy

Ospedale San Raffaele; 🇮🇹 Milan, Lombardy, Italy

Neurociencias Estudios Clinicos S.C.; 🇲🇽 Culiacán, Sinaloa, Mexico

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie; 🇵🇱 Lublin, Poland

FSBI 'Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Techno; 🇷🇺 Moscow, Moscow Oblast, Russia

SBEI HPE " Perm State Medical University n.a. Academician E.A. Vagner" of the MoH of the RF; 🇷🇺 Perm, Russia

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States

Arizona Neuroscience Research LLC; 🇺🇸 Phoenix, Arizona, United States

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