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

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ClinicalTrials.gov Identifier: NCT04847596
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Relapsing Multiple Sclerosis Other: Ofatumumab Other: Covid-19 vaccine

Study Design
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Study Type : Observational
Estimated Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : May 21, 2021
Estimated Primary Completion Date : April 11, 2023
Estimated Study Completion Date : April 11, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ofatumumab

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations
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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): NCT04847596


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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United States, Arizona
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85018
United States, Michigan
Novartis Investigative Site Recruiting
Owosso, Michigan, United States, 48867
United States, Missouri
Novartis Investigative Site Recruiting
Saint Louis, Missouri, United States, 63131
United States, New York
Novartis Investigative Site Recruiting
Plainview, New York, United States, 11803
Puerto Rico
Novartis Investigative Site Recruiting
Guaynabo, Puerto Rico, 00968
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04847596    
Other Study ID Numbers: COMB157GUS18
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
COVID-19
vaccine
ofatumumab
 SARS-coV2
antibody
open-label
Additional relevant MeSH terms:
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COVID-19
Multiple Sclerosis
Sclerosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ofatumumab
Antineoplastic Agents