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

Purpose

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.

Condition

  • Relapsing Multiple Sclerosis

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ofatumumab 		Subcutaneous injection
  • Biological: Ofatumumab
    subcutaneous injection of 20 mg ofatumumab every 4 weeks
  • Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap)
    0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
  • Biological: 13-valent pneumococcal conjugate vaccine (13-PCV)
    0.5mL Vial/Syringe
  • Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV)
    0.5mL Vial/Syringe
  • Biological: Seasonal Quadrivalent influenza vaccine
    Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
  • Biological: Keyhole limpet hemocyanin (KLH) neo-antigen
    1mg Vial

Recruiting Locations

University of Kansas Hospital
Kansas City, Kansas 66160
Contact:
Lisa Schmidt
913-588-0614
lschmidt@kumc.edu

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

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