A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

January 23, 2023 updated by: Novartis Pharmaceuticals

An Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously

This is a single arm, pilot multicenter prospective study in up to 22 participants with relapsing multiple sclerosis. Patients screened for the study can either be scheduled for vaccine, have received a single vaccine with a scheduled second dose, or already completed full course (two dose) vaccination. Fully vaccinated participants must be able to complete immune assay No.1 ≥ 14 days after the second dose of vaccine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Guaynabo, Puerto Rico, 00968
        • Novartis Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Novartis Investigative Site
    • Michigan
      • Owosso, Michigan, United States, 48867
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Novartis Investigative Site
    • New York
      • Plainview, New York, United States, 11803
        • Novartis Investigative Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment

Description

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation in the study
  2. Age 18-55 years old inclusive at Screening
  3. Diagnosis of relapsing MS by 2017 revised McDonald criteria
  4. Must be willing to comply with the study schedule
  5. Have received/scheduled vaccination with a FDA approved for emergency use COVID-19 mRNA vaccine (either Pfizer or Moderna) (i) either been scheduled for vaccine, (ii) received a single vaccine with a scheduled second dose, or (iii) already completed full course (two dose) vaccination.
  6. Currently receiving ofatumumab for the treatment of RMS (Preoftumumab serology with Hepatitis B testing showing no active or latent infection, as well as serum IgG results to be recorded in the database if available)

Exclusion Criteria:

  1. Known clinical diagnosis of COVID-19 prior to screening based on investigator's or patient's personal physician's judgement
  2. Has a contraindication to receiving an mRNA COVID-19 vaccine
  3. Has an immediate allergic reaction to past vaccine or injection
  4. Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to vaccination as determined by the HCP
  5. Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
  6. Prior treatment with S1P agent within 2 months of study enrollment
  7. Prior treatment with natalizumab within 6 months of study enrollment
  8. Contraindications to ofatumumab treatment as per the USPI will be adhered to which include active infection hepatitis B infection, progressive multifocal leukoencephalopathy and pregnancy.
  9. Participation in another interventional clinical trial within 14 days before enrollment.
  10. Have been treated with any of the medications as described in the full protocol
  11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 months after stopping medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
participants with RMS treated with ofatumumab
Relapsing MS participants receiving a full course (two doses) of a COVID-19 mRNA vaccine after starting ofatumumab 20 mg subcutaneous treatment
Other: Ofatumumab
Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
Other: Covid-19 vaccine
Prospective observational cohort study. There is no treatment allocation. Participants will obtain the COVID-19 FDA approved Emergency Use mRNA vaccine through their HCP (private insurance) or appropriate federal, state or local program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving immune response - immune assay No. 1
Time Frame: 14 days after full course vaccination (two doses)
Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay. (yes/no)
14 days after full course vaccination (two doses)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving immune response - immune assay No. 2
Time Frame: 90 days post assay 1
Achieving immune response as defined by a positive SARS-CoV-2 qualitative IgG antibody assay 90 days after assay No. 1 (yes/no)
90 days post assay 1
Adverse events/serious adverse events
Time Frame: 120 days after full course vaccination

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.

Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.
120 days after full course vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Actual)

February 18, 2022

Study Completion (Actual)

February 18, 2022

Study Registration Dates

First Submitted

April 14, 2021

First Submitted That Met QC Criteria

April 14, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMB157GUS18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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