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Can ocrelizumab tame MS inflammation from the start? new study aims to find out
NCT ID NCT04466150
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether the drug ocrelizumab (Ocrevus) can improve signs of inflammation in the spinal fluid of people newly diagnosed with relapsing multiple sclerosis (MS) or a high-risk first attack (clinically isolated syndrome). Thirty participants will receive ocrelizumab and have their spinal fluid checked before and after three years of treatment. The goal is to see if early treatment can reduce chronic inflammation in the central nervous system.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ocrelizumab (Ocrevus)
- What this could lead to
- If successful, this could show that early treatment with ocrelizumab reduces long-term inflammation in the central nervous system, potentially slowing MS progression.
- What could go wrong
- This is a small, early-phase biomarker study with only 30 participants and no placebo group. It measures lab markers, not clinical outcomes, so benefits for patients remain uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2020
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of California San Francisco
San Francisco, California, 94158, United States
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