RECRUITING

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

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Conditions

Multiple Sclerosis, Relapsing-Remittingmultiple sclerosisocrelizumabmagnetic resonance imaging (MRI)optical coherence tomography angiography (OCTA)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)..

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

Quick Facts

Study Start:2021-11-20
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04458688

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. Age 18 to 60 years old.
  4. 4. Ethnicity: self-identified as African American or Caucasian.
  5. 5. Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria.
  6. 6. EDSS from 0 to 6 (inclusive) at baseline visit.
  7. 7. Able to give informed consent.
  8. 8. Able to have MRI scans.
  1. 1. Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab.
  2. 2. Failed 2 or more DMTs.
  3. 3. Treatment with immunosuppressant agents, such as chemotherapeutic agents.
  4. 4. Claustrophobia.
  5. 5. Allergy to contrast.
  6. 6. Significant medical problems that the PI determines will interfere with the conduct of the study.
  7. 7. Relapse or use of corticosteroids within 30 days prior to baseline visit.
  8. 8. Pregnancy.
  9. 9. History of kidney or liver insufficiency.
  10. 10. History of malignancy.

Contacts and Locations

Study Contact

Zahid Latif
CONTACT
3139660473
zahidlatif@wayne.edu
Kelly Jia
CONTACT
313-966-9407
xjia@med.wayne.edu

Principal Investigator

Evanthia Bernitsas, MD
PRINCIPAL_INVESTIGATOR
Wayne State University

Study Locations (Sites)

Wayne State University
Detroit, Michigan, 48201
United States

Collaborators and Investigators

Sponsor: Wayne State University

  • Evanthia Bernitsas, MD, PRINCIPAL_INVESTIGATOR, Wayne State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-20
Study Completion Date2030-12

Study Record Updates

Study Start Date2021-11-20
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • multiple sclerosis
  • ocrelizumab
  • magnetic resonance imaging (MRI)
  • optical coherence tomography angiography (OCTA)

Additional Relevant MeSH Terms

  • Multiple Sclerosis, Relapsing-Remitting