Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis

Completed

Conditions studied: Multiple Sclerosis

In brief

This is a Phase IV, prospective, open-label, single-center, observational, longitudinal, single blinded study. The investigators will examine the effects of Ocrelizumab on cognitive, patient reported outcomes (PROs), quality of life (QoL), multiple sclerosis functional composite (MSFC), working status and magnetic resonance imaging (MRI) outcomes across 12 and 24 months.

Key facts

Study ID

NCT03025269

Run by

University at Buffalo

People needed

30

Starts

2017-11-15

Expected to finish

2022-01-08

Last updated by the study team

2022-03-11

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient diagnosed with MS according to McDonald criteria
• Age 18-60
• Relapsing disease course
• Expanded Disability Status Scale (EDSS) ≤5.5
• Disease duration <20 years
• Treatment naive to Ocrelizumab
• Willing and able to comply with the study procedures for the duration of the trial
• Given written informed consent and signed HIPAA Authorization prior to the study
• Normal kidney functioning (creatinine clearance >59)
• None of the exclusion criteria

You may not qualify if…

• PI guidelines for contraindications of Ocrelizumab (available after FDA approval)
• Significant cognitive impairment (in the opinion of the investigator) or other significant neurological or medical condition that would compromise adherence and completion of the trial, including major depression and developmental disorders affecting cognition
• Have received treatment within 30 days prior to enrollment with steroids or any other concomitant immunomodulatory therapies
• Have received treatment with Natalizumab within 8 weeks prior to enrollment; this is needed to increase confidence that there are no signs of progressive multifocal leukoencephalopathy (PML) on baseline MRI
• Less than 6 months from the use of immunosuppressant agents (e.g., including but not limited to mitoxantrone, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil)
• Have received an investigational drug or experimental procedure within the past 30 days
• Women who are pregnant, lactating, or of childbearing age who do not consent to approved contraceptive use during the study
• Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation in this study
• Hypersensitivity to trial medications

Where it is running

• Jacobs Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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