Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT03025269
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03025269
Study Brief:
Protocol Section:
NCT03025269