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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.