Trial | NCT04466150  Report issue

Official Title

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    30
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.
Newly diagnosed relapsing multiple sclerosis (MS) and high risk clinically isolated syndrome (CIS) patients age 18-50 will be treated with ocrelizumab within 90 days of first clinical MS/CIS presentation and re-dosed as maintenance therapy every 6 months for 3 years to see if treatment favorably alters CSF markers of chronic inflammation

Investigators hope data that will provide a foundation for further studies that treating relapsing MS patients at clinical onset (using a B-cell depleting therapy) may improve longer-term outcomes.
Study Started
Aug 30
2020
Primary Completion
Dec 31
2026
Anticipated
Study Completion
Jul 31
2027
Anticipated
Last Update
Sep 21
2023

Drug Ocrelizumab

open label biomarker study

  • Other names: Ocrevus

Ocrelizumab treated Active Comparator

Participants age 18-50 with a first clinical presentation of MS or high-risk CIS diagnosed within 90 days of screening will be treated with ocrelizumab (300 mg IV x 2 doses given 2 weeks apart) at disease origin and with maintenance ocrelizumab 600 mg every 6 months through 30 months with a final study visit at 3 years

Observational study cohort No Intervention

Subjects enrolled into an observational study matched for the same disease duration and who are either untreated or treated with alternate MS disease modifying therapies will serve as a parallel reference group

Criteria 

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 contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception.
Examples of barrier methods supplemented with the use of spermicide include male or female condom, cap, diaphragm, or sponge.

Exclusion Criteria:

Patients will be excluded from the study based on the following criteria:

Pregnancy, lactation, or intention to become pregnant during the study
Progressive MS (primary or secondary)
Disease other than MS to explain the first demyelinating event; including AQP4 IgG seropositivity
Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator
Unwilling or unsafe to proceed with MRI
Active hepatitis B virus infection
Untreated latent or active tuberculosis
Active hepatitis C virus infection
HIV infection
Hypersensitivity to trial medications
History of life-threatening infusion reaction to MAbs
No Results Posted