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

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

ClinicalTrials.gov Identifier: NCT03650114

Novartis Reference Number: COMB157G2399

Last Update: Jan 07, 2021

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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).

Condition

Relapsing Multiple Sclerosis

Phase

Phase 3

Overall status

Recruiting

Enrollment count

2010 participants

Start date

Dec 28, 2018

Completion date

Oct 03, 2028

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

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

Eligibility Criteria

Inclusion Criteria:

Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
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

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