Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset
NCT ID: NCT04466150
Last Updated: 2025-01-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-08-30
Study Completion Date
2027-07-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Relapsing Multiple Sclerosis
Clinically Isolated Syndrome
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
This is a nested case-controlled study.
By nesting this ocrelizumab interventional treatment arm within an observational study, the investigators will be able to compare treatment with ocrelizumab to usual care for patients who are matched for the same disease duration. Because the same clinical and biomarker assessments will be acquired for both the ocrelizumab interventional arm and the usual care observational cohort, this study will allow direct comparison of ocrelizumab with a usual care control group.
By nesting this ocrelizumab interventional treatment arm within an observational study, the investigators will be able to compare treatment with ocrelizumab to usual care for patients who are matched for the same disease duration. Because the same clinical and biomarker assessments will be acquired for both the ocrelizumab interventional arm and the usual care observational cohort, this study will allow direct comparison of ocrelizumab with a usual care control group.
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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Ocrelizumab treated
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
Group Type
ACTIVE_COMPARATOR
Ocrelizumab
Intervention Type
DRUG
open label biomarker study
Observational study cohort
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
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Ocrelizumab
open label biomarker study
Intervention Type
DRUG
Other Intervention Names
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Ocrevus
Eligibility Criteria
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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 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.
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Genentech, Inc.
INDUSTRY
Sponsor Role
collaborator
Valhalla Foundation
OTHER
Sponsor Role
collaborator
University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Bruce Cree, MD, PhD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Site Status
Countries
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United States
References
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Other Identifiers
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RO-IIS-2018-10828
Identifier Type: -
Identifier Source: org_study_id
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Effects of Ocrevus in Relapsing Multiple Sclerosis
NCT04387734
ACTIVE_NOT_RECRUITING
PHASE4
Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab
NCT04377555
ACTIVE_NOT_RECRUITING
PHASE4
Mechanistic Study of Ocrevus
NCT04459988
COMPLETED
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
NCT02637856
COMPLETED
PHASE3
Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)
NCT02688985
COMPLETED
PHASE3
Mechanism of Action of Ocrelizumab in Multiple Sclerosis
NCT03344094
COMPLETED
A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting
NCT03589105
COMPLETED
PHASE4
Ocrelizumab for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease.
NCT04877457
TERMINATED
PHASE4
Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis
NCT06495593
RECRUITING
PHASE4
Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis
NCT03025269
COMPLETED
Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714
NCT03691077
UNKNOWN
PHASE3
Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS
NCT04838015
UNKNOWN
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis
NCT01412333
COMPLETED
PHASE3
Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
NCT03138525
COMPLETED
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
NCT01194570
COMPLETED
PHASE3
WOE of Anti-CD20 Therapies
NCT06121349
COMPLETED
The Possible Neuroprotective Effect of Ocrelizumab Via VEGF Protein Expression in Relapsing Multiple Sclerosis Patients
NCT04902690
UNKNOWN
Effects of Gilenya (Fingolimod) on Thalamus Pathology and Cognitive Impairment in Patients With Relapsing Forms of Multiple Sclerosis
NCT02021162
COMPLETED
Ocrelizumab Access by Socio-Economic Status
NCT05131984
COMPLETED