Not currently recruiting at University of California Health

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

a study on Multiple Sclerosis Vaccine

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

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).

COVID-19 sub-study:

The purpose of this research sub-study is to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc. Note: Novartis is not supplying the SARS-CoV-2 vaccine.

Official Title

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis, ofatumumab, Multiple Sclerosis, Sclerosis, Vaccines, Heptavalent Pneumococcal Conjugate Vaccine, Keyhole-limpet hemocyanin, 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

Eligibility

You can join if…

Open to people ages 18-100

  1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
  2. Written informed consent

You CAN'T join if...

  • Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
  • Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
  • Subjects taking medications prohibited by the protocol
  • Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

  1. Informed consent
  2. Actively enrolled in the COMB157G2399 Study
  3. 12 weeks of continuous treatment within the COMB157G2399 Study
  4. 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

Locations

  • University of California Davis in progress, not accepting new patients
    Sacramento California 95817 United States
  • Fullerton Neuro and Headache Ctr in progress, not accepting new patients
    Fullerton California 92835 United States
  • Evergreen Health Multiple Sclerosis Center accepting new patients
    Kirkland Washington 98034 United States
  • Billings Clinic accepting new patients
    Billings Montana 59101 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03650114
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 2060 study participants
Last Updated