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Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04458688
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Evanthia Bernitsas, MD, Wayne State University

Brief Summary:
The investigators intend to examine the effects of ocrelizumab use in African American multiple sclerosis disease course compared to Caucasian disease course utilizing imaging measures with magnetic resonance imaging (MRI) and optical coherence tomography angiography (OCT-A)..

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing-Remitting Other: Observation of Ocrelizumab as Treatment in RRMS Patients

Detailed Description:

Multiple sclerosis (MS) is a disease of the central nervous system (CNS). Several lines of evidence suggest that MS is an autoimmune disease with both T and B-cell activity leading to CNS inflammation which results in demyelinating injury. Ocrelizumab was FDA approved in March 2017 for relapsing remitting (RRMS) and primary progressive multiple sclerosis (PPMS) by depleting B cells. It has shown to be effective in reducing the annualized relapse rate, decreasing disability progression, and reducing the number of new and active MRI brain lesions.

Previous research studies have reported a more aggressive course in African Americans with MS, more lesions on the MRI scan, and more severe injury to layers of the eye (specifically in the retina) compared to Caucasians.

This is a novel study investigating the effect of ocrelizumab in African American relapsing multiple sclerosis (RMS) patients compared to Caucasian RMS patients using imaging measures, specifically multimodal magnetic resonance imaging (MRI) and optical coherence tomography-angiography (OCTA). This is a non-drug intervention study; therefore, patients who are recruited will have already decided to make ocrelizumab their disease-modifying therapy before enrollment. The study will recruit 86 (including 6 potential screen fails) patients in total (40 African American patients and 40 Caucasian patients who are matched by age, sex, disease duration, and disease disability. The study will consist of 5 visits in six-month intervals across two years.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : December 2030

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Group/Cohort Intervention/treatment
African Americans with RRMS
Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: Self-described as African American.
Other: Observation of Ocrelizumab as Treatment in RRMS Patients
It is decided by the patient and their physician to begin taking ocrelizumab PRIOR to study enrollment. The study is only observing the effects of ocrelizumab as a pre-decided treatment option for a patient's MS.
Other Name: Observing Ocrelizumab Use

Caucasian American with RRMS
Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: Self-described as Caucasian American.
Other: Observation of Ocrelizumab as Treatment in RRMS Patients
It is decided by the patient and their physician to begin taking ocrelizumab PRIOR to study enrollment. The study is only observing the effects of ocrelizumab as a pre-decided treatment option for a patient's MS.
Other Name: Observing Ocrelizumab Use




Primary Outcome Measures :
  1. Magnetic Resonance Imaging (MRI) with contrast [ Time Frame: Change in MRI at BL, Month 6, Month 12, and Month 24 ]
    Approximately a 1 hour MRI with contrast (administered via IV)

  2. Optical Coherence Tomography Angiography (OCTA) [ Time Frame: Change in OCTA at BL, Month 12, and Month 24 ]
    Eye scan with contrast (administered via IV)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: self-described as African American or Caucasian.
Criteria

Inclusion Criteria:

  1. Patients who have chosen to start ocrelizumab and for whom ocrelizumab is determined to be the most appropriate standard-of-care disease modifying therapy (DMT) by the treating neurologist.
  2. May be treatment naive, or had suboptimal response to no more than one DMT after an adequate course of treatment (defined as treatment duration of 6+ months).
  3. Age 18 to 60 years old.
  4. Ethnicity: self-identified as African American or Caucasian.
  5. Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria.
  6. EDSS from 0 to 6 (inclusive) at baseline visit.
  7. Able to give informed consent.
  8. Able to have MRI scans.

Exclusion Criteria:

  1. Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab.
  2. Failed 2 or more DMTs.
  3. Treatment with immunosuppressant agents, such as chemotherapeutic agents.
  4. Claustrophobia.
  5. Allergy to contrast.
  6. Significant medical problems that the PI determines will interfere with the conduct of the study.
  7. Relapse or use of corticosteroids within 30 days prior to baseline visit.
  8. Pregnancy.
  9. History of kidney or liver insufficiency.
  10. History of malignancy.

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): NCT04458688


Contacts
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Contact: Madeline Bross, BS 313-966-0473 mbross@med.wayne.edu
Contact: Melody Hackett, BS 313-966-0473 mgilroy@med.wayne.edu

Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Evanthia Bernitsas, MD Wayne State University
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Responsible Party: Evanthia Bernitsas, MD, Prinipal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT04458688    
Other Study ID Numbers: ML41569
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol, ICFs, study reports, statistical analysis plans, secure CRFs, and results will be shared with Roche/Genentech Inc. All patient data will have a unique number/digit code when sent to protect patient identity.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available for the duration of the study and up to 15 years after the last patient has completed the study.
Access Criteria: All data will be stored and shared in electronic case report form (eCRF) format.

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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
Keywords provided by Evanthia Bernitsas, MD, Wayne State University:
multiple sclerosis
ocrelizumab
magnetic resonance imaging (MRI)
optical coherence tomography angiography (OCTA)
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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