Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 March 2022
• Main ID: NCT03025269
• Date of registration: 16/01/2017
• Prospective Registration: Yes
• Primary sponsor: University at Buffalo
• Public title: Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis
• Scientific title: Effect of Ocrelizumab on Gray Matter Pathology, Leptomeningeal Inflammation and Cognitive Dysfunction in Multiple Sclerosis
• Date of first enrolment: November 15, 2017
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03025269
• Study type: Observational

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Ocrelizumab

Primary Outcome(s)

Absolute thalamic atrophy 12 [Time Frame: 12 months]

Inflammation foci 24 [Time Frame: 24 months]

Percent change cortical atrophy 12 [Time Frame: 12 months]

Absolute cortical atrophy 12 [Time Frame: 12 months]

Absolute thalamic atrophy 24 [Time Frame: 24 months]

Percent thalamic atrophy 12 [Time Frame: 12 months]

Percent cortical atrophy 24 [Time Frame: 24 months]

Absolute cortical atrophy 24 [Time Frame: 24 months]

Inflammation foci 12 [Time Frame: 12 months]

Percent thalamic atrophy 24 [Time Frame: 24 months]

Secondary Outcome(s)

Verbal learning 12 [Time Frame: 12 months]

SDMT 24 [Time Frame: 24 months]

SDMT score 12 [Time Frame: 12 months]

Verbal learning 24 [Time Frame: 24 months]

Memory 12 [Time Frame: 12 months]

Memory 24 [Time Frame: 24 months]

Secondary ID(s)

STUDY00001202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors