Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With Ofatumumab

  • STATUS
    Recruiting
  • End date
    Jan 16, 2023
  • participants needed
    40
  • sponsor
    Novartis Pharmaceuticals
Updated on 22 September 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (8.7 mi away) Contact
+7 other location
relapsing multiple sclerosis

Summary

This study aims to understand whether patients with MS can mount an immune response to SARS-CoV-2 mRNA vaccines when vaccinated either before initiation of ofatumumab treatment or at least 4 weeks after commencing ofatumumab treatment.

Description

This is a two cohort, multicenter, open-label, prospective study of 40 (optionally up to 60) patients with relapsing multiple sclerosis (RMS) planning to undergo a SARS-CoV-2 mRNA vaccination as part of clinical routine. The maximal duration of the study for an individual patient is 22 months.

  • The first cohort will be RMS patients receiving SARS-CoV-2 mRNA vaccine as part of clinical routine prior to starting ofatumumab treatment.
  • The second cohort will be participants receiving SARS-CoV-2 mRNA vaccine as part of clinical routine while already stable on ofatumumab treatment for at least 4 weeks (since first dose).

Development of SARS-CoV-2 specific T-cells and functional anti-SARS-CoV-2 antibodies will be investigated for up to 18 months after the participants' vaccination.

Details
Condition Multiple Sclerosis, multiple sclerosis (ms)
Treatment Ofatumumab
Clinical Study IdentifierNCT04869358
SponsorNovartis Pharmaceuticals
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Relapsing Multiple Sclerosis (RMS) diagnosis
eligible for ofatumumab treatment
willing and eligible to receive SARS-CoV-2 mRNA vaccine

Exclusion Criteria

known prior or current COVID-19 infection
previous treatment with BTK inhibitor or anti-CD20 therapy other than ofatumumab
Other protocol-defined inclusion/exclusion criteria may apply
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note