Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset ((IMPACT MS))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466150
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborators:
Genentech, Inc.
Valhalla Charitable Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Relapsing Multiple Sclerosis Clinically Isolated Syndrome Drug: Ocrelizumab Phase 4

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset
Actual Study Start Date : August 30, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Active Comparator: 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
Drug: Ocrelizumab
open label biomarker study
Other Name: Ocrevus

No Intervention: 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



Primary Outcome Measures :
  1. Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after treatment with ocrelizumab [ Time Frame: 3 years ]
    Comparison of intrathecal synthesis of gammaglobulins in treatment-naïve relapsing MS and clinically isolated syndrome participants before and after 3 years of treatment with ocrelizumab. Intrathecal synthesis is measured by either a) normalization of the IgG Index (0.6 is the upper limit of normal) or b) eradication of oligoclonal bands



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04466150


Contacts
Layout table for location contacts
Contact: Robin Lincoln, BS 415-502-7216 robin.lincoln@ucsf.edu
Contact: Naomi Okinishi, BS MPH 415-502-7604 naomi.okinishi@ucsf.edu

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Genentech, Inc.
Valhalla Charitable Foundation
Investigators
Layout table for investigator information
Principal Investigator: Bruce Cree, MD, PhD, MAS University of California, San Francisco
Publications:
raditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (TREAT-MS) Johns Hopkins University NCT03500328
https://www.emdserono.com/content/dam/web/corporate/non-images/country-specifics/us/pi/mavenclad-pi.pdf
https://www.gene.com/download/pdf/ocrevus_prescribing.pdf.

Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04466150    
Other Study ID Numbers: RO-IIS-2018-10828
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Outcome data (biomarker, genotypic) as well as study data related to diagnosis, disease presentation, and date of birth, along with biological specimens collected as part of the study, may be shared (in coded form) in the future with other qualified researchers, government data registries, and/or commercial entities on a case by case basis at the discretion of the PI and Co-PIs. Any such investigator/entity will be required to provide appropriate documentation that the research being conducted has been approved by an Institutional Review Board and demonstrate that it will be of scientific value.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Clinical study report to Sponsor estimated May 2025. Other data/samples will be shared after initial results are published and on a case by case basis.
Access Criteria: Collaborators, other scientific Investigators, Government Health and research agencies, Commercial Companies may request data and/or samples. The request process includes submitting a research proposal, having necessary IRB approval and material transfer agreements.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs