Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset (NCT04466150) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset
United States30 participantsStarted 2020-08-30
Plain-language summary
Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients will be treated with ocrelizumab at disease onset to see if treatment favorably alters CSF markers of chronic inflammation.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
Patients must meet the following criteria to be included in this study:
* Signed Consent Form
* High-risk clinically isolated syndrome or relapsing MS Diagnosis (based on 2017 International Panel Criteria)
* Age 18-50 inclusive
* Screening within 90 days of first clinical demyelinating event typical of MS with 1 or more inactive lesions typical of MS
* No prior MS disease modifying therapy
* No corticosteroids within 7 days of first ocrelizumab treatment
* EDSS \< 4.0
* A negative urine or serum pregnancy test must be available for premenopausal women and for women \<12 months after the onset of menopause, unless they have undergone surgical sterilization.
* Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use one method of contraception with a failure rate of \<1% per year or a barrier method supplemented with spermicide. Contraception must continue for the duration of study treatment and for at least 24 weeks after the last dose of study treatment. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause of other than menopause), and has not undergone surgical sterilization (removal of the ovaries and/or uterus).
* Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tube ligation, male sterilization, established hormonal contraceptive…
What they're measuring
1
Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after treatment with ocrelizumab