Long-term Safety Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

  • STATUS
    Recruiting
  • End date
    Oct 3, 2028
  • participants needed
    2010
  • sponsor
    Novartis Pharmaceuticals
Updated on 11 September 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (7.2 mi away) Contact
+261 other location
tetanus
ofatumumab
pneumococcal conjugate vaccine

Summary

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

Details
Condition Relapsing Multiple Sclerosis
Treatment Ofatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap), 13-valent pneumococcal conjugate vaccine (13-PCV), 23-valent pneumococcal polysaccharide vaccine (23-PPV), Seasonal Quadrivalent influenza vaccine, Keyhole limpet hemocyanin (KLH) neo-antigen
Clinical Study IdentifierNCT03650114
SponsorNovartis Pharmaceuticals
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed consent
Actively enrolled in the COMB157G2399 Study
12 weeks of continuous treatment within the COMB157G2399 Study
prior vaccination history as per protocol-defined

Exclusion Criteria

known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
allergies to egg or shellfish
any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit
Other protocol-defined inclusion/exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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

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