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~81 spots leftby Jan 2026

Ocrelizumab for Progressive Multiple Sclerosis
(CONSONANCE Trial)

Recruiting at 214 trial locations

Overseen ByReference Study ID Number: MN39159 https://forpatients.roche.com/

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with Progressive Multiple Sclerosis (PMS) who've had disability progression in the last 2 years, can use a smartphone with Wi-Fi, and have an EDSS score of 6.5 or less. Women must agree to contraception during treatment and afterward. Exclusions include recent other MS treatments, severe immune conditions, certain drug intolerances, active infections, pregnancy, or previous ocrelizumab use.

Inclusion Criteria

Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment

Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers

Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist

See 3 more

Exclusion Criteria

I haven't taken any corticosteroids in the last 4 weeks.

History or currently active primary or secondary immunodeficiency

I've had treatments targeting B-cells, but not rituximab in the last 6 months, and my B-cell levels are normal.

See 32 more

Treatment Details

Interventions

Ocrelizumab (Monoclonal Antibodies)

Trial OverviewThe study tests Ocrelizumab's effectiveness and safety in treating PMS. It's an open-label trial where all participants receive the drug; there are no comparison groups. The focus is on how well it works over time and what side effects occur.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: OcrelizumabExperimental Treatment1 Intervention

Ocrelizumab will be administered via intravenous (IV) infusion.

Ocrelizumab is already approved in Canada for the following indications:

Approved in Canada as Ocrevus for:

Primary progressive multiple sclerosis
Relapsing forms of multiple sclerosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Ocrelizumab for Progressive Multiple Sclerosis (CONSONANCE Trial)