This study is in progress, not accepting new patients

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
    Sacramento California 95817 United States
  • Fullerton Neuro and Headache Ctr
    Fullerton California 92835 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT03650114
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 1882 people participating
Last Updated