RECRUITING

9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis

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Conditions

Relapsing Multiple Sclerosis

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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

We aim to assess the effect of Ofatumumab on microglial activation using \[F-18\]PBR06 PET in MS patients in relation to changes in serum markers, MRI abnormalities and clinical impairment longitudinally over 9 months. Specific Aims: Specific Aim 1: To determine the effect of Ofatumumab on microglial activation in MS over 9 months. Specific Aim 2: To determine the time course of effect of Ofatumumab on microglial activation and its relationship with peripheral B-cell depletion, serum neurofilament light (sNfL) chain and glial-fibrillary acid protein (GFAP) levels and other serum biomarkers Specific Aim 3: To determine the relationship of PET changes following Ofatumumab initiation with 3T MRI changes and clinical parameters.

Official Title

Open-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis

Quick Facts

Study Start:2020-09-21
Study Completion:2021-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04510220

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. * Patients diagnosed with active, relapsing MS course. Active disease is defined by at least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan or MRI scan with new or unequivocally enlarging T2 lesions in previous year.
  2. * Age 18 to 60 years
  3. * EDSS 0 to 5.5
  4. * Subjects either untreated or treated with disease modifying therapies other than those listed in exclusion criteria
  5. * Agree to start treatment with ofatumumab and comply with study procedures for the duration of the study
  6. * No other systemic disease or neurological disorders requiring chronic or acute steroid or other immunosuppressive treatment
  7. * No known hypersensitivity reactions to contrast agents
  8. * None of the exclusion criteria
  1. * Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator.
  2. * Subjects with primary progressive MS or SPMS without disease activity.
  3. * Disease duration of more than 10 years in patients with an EDSS score of 2 or less
  4. * Subjects meeting criteria for neuromyelitis optica.
  5. * Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  6. * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 6 months after stopping study medication.
  7. * Subjects with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS or with an immunodeficiency syndrome.
  8. * Subjects with a history of the following:
  9. 1. History of malignancy
  10. 2. History of alcohol or drug abuse
  11. 3. Primary or secondary immunodeficiency
  12. 4. Prior hematopoietic stem cell transplantation
  13. 5. History of transplantation or anti-rejection therapy
  14. * Subjects with abnormal CD19, WBC, lymphocyte counts or abnormal IgG levels
  15. * Subjects with active systemic bacterial, viral or fungal infections, or known to have acquired immunodeficiency syndrome (AIDS).
  16. * Subjects with neurological symptoms consistent with PML or confirmed PML.
  17. * Subjects at risk of developing or having reactivation of syphilis or tuberculosis (eg subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated). Testing for syphilis and tuberculosis will be done at Screening.
  18. * Subjects with low affinity binders (LAB) for TSPO radioligand
  19. * Subjects with abnormal serum creatinine levels
  20. * Subjects with any contraindications to PET/CT or MRI procedures (e.g. claustrophobia, MRI-incompatible implants or pacemakers, renal failure)
  21. * Subjects treated with other disease modifying treatments within their respective pre-specified washout periods will be excluded:

Contacts and Locations

Study Contact

Tarun Singhal, MD
CONTACT
617-732-5566
tsinghal@bwh.harvard.edu

Principal Investigator

Tarun Singhal, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Partners MS Center, 60 Fenwood Road
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Tarun Singhal, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

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 Date2020-09-21
Study Completion Date2021-12-31

Study Record Updates

Study Start Date2020-09-21
Study Completion Date2021-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Relapsing Multiple Sclerosis