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Monoclonal Antibodies

Ocrelizumab for Progressive Multiple Sclerosis (CONSONANCE Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

EDSS (Expanded Disability Status Scale) </ =6.5 at screening

Be older than 18 years old

Must not have

Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks

Participants in a severely immunocompromised state until the condition resolves

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 96, week 96 to week 192 and baseline to week 192

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new MS treatment to see if it is effective and safe.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Ocrelizumab may cause infusion reactions like itching or rash, infections due to weakened immunity, potential liver issues indicated by blood tests changes. There might also be a risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk with assistance or devices.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken azathioprine, cyclophosphamide, mycophenolate mofetil, or methotrexate in the last 3 months.

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My immune system is currently not severely weakened.

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I have been treated with ocrelizumab before.

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I do not have good veins for IV access.

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I am currently being treated or monitored for cancer recurrence.

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I cannot tolerate or am not allowed to take corticosteroids.

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I haven't taken daclizumab, ozanimod, or figolimod in the last 8 weeks.

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My condition is relapsing-remitting MS.

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I was treated with natalizumab and PML was not ruled out following a specific procedure.

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I have never had treatment with alemtuzumab, total body irradiation, or bone marrow transplantation.

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I have or had a brain infection called PML.

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I have been diagnosed with a neurological disorder.

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I do not need long-term steroids or immunosuppressants.

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I cannot undergo an MRI scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 96, week 96 to week 192 and baseline to week 192

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 96, week 96 to week 192 and baseline to week 192

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 96, week 96 to week 192 and baseline to week 192 for reporting.