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

Phase 1

• Conditions: Primary Progressive Multiple Sclerosis (PPMS)Relapsing Multiple Sclerosis (RMS); MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10063401Term: Primary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-005746-15-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-08
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1107

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) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

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