A new randomized, blinded discontinuation trial of ocrelizumab in patients with early relapsing-remitting multiple sclerosis (MS) is expected to open soon.

During the trial, an estimated 175 participants will be initiated with ocrelizumab at a dose of 300 mg twice separated by 2 weeks, the standard approved dose for the treatment. This will be followed by the administration of a further 600 mg of ocrelizumab at month 6 and month 12.

After the 12th month, participants will either receive placebo infusions every 6 months, ocrelizumab every 6 months, or ocrelizumab infusions at month 18 and month 24 and then placebo every 6 months for a total of 48 months.


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The primary outcome measures will be the absence of clinical relapse and the absence of new and enlarging T2 lesions. Secondary outcome measures include infusion-related reactions, serious adverse events, malignancies, the change in Expanded Disability Status Scale scores, and the proportion of participants with infections.

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Participants aged 18 to 55 years who have at least 1 clinical episode of early MS and have had a disease duration of 2 years or less from the first symptom are eligible. See the trial site for full eligibility criteria.

The trial is not yet recruiting participants. It is expected to start on April 30, 2022, and run through to April 30, 2028. It is sponsored by the National Institute of Allergy and Infectious Diseases and Autoimmunity Centers of Excellence.

Ocrelizumab is a disease-modifying treatment for MS by Genentech, a member of the Roche group. It is a humanized monoclonal antibody that targets CD20-positive B lymphocytes. These are involved in the immune attack against the myelin sheath so by neutralizing them, ocrelizumab aims to reduce the effect of the disease on the nervous system.

Reference

Ocrelizumab discontinuation in relapsing multiple sclerosis. US National Library of Medicine. Updated March 18, 2022. Accessed March 20. 2022.