An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
Overview
- Phase
- Phase 3
- Intervention
- Ofatumumab
- Conditions
- Relapsing Multiple Sclerosis
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 1882
- Locations
- 377
- Primary Endpoint
- Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
- Status
- Active, Not Recruiting
- Last Updated
- last month
Overview
Brief 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.
Investigators
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
Arms & Interventions
Ofatumumab
Subcutaneous injection
Intervention: Ofatumumab
Ofatumumab
Subcutaneous injection
Intervention: Tetanus toxoid (TT) containing vaccine (Td, Tdap)
Ofatumumab
Subcutaneous injection
Intervention: 13-valent pneumococcal conjugate vaccine (13-PCV)
Ofatumumab
Subcutaneous injection
Intervention: 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Ofatumumab
Subcutaneous injection
Intervention: Seasonal Quadrivalent influenza vaccine
Ofatumumab
Subcutaneous injection
Intervention: Keyhole limpet hemocyanin (KLH) neo-antigen
Outcomes
Primary Outcomes
Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
Time Frame: Up to 8 years
Secondary Outcomes
- Number of relapse rates per year(Data from the core studies through the first 5 years in this study.)
- Patients with confirmed 3 and 6 month disability worsening(During the first 5 years of treatment in the study.)
- Patients with confirmed 6, 12, and 24 month disability improvement and improvement during the first 5 years of the study.(During the first 5 years of treatment in the study.)
- Patients with changes in Expanded Disability Status Scale (EDSS) scores(Data from the core studies through the first 5 years in this study, (depending on if first dose was in the core or in this extension study or comparator randomization))
- Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores(During the first 5 years of the study.)
- Changes in the Magnetic Resonance Image (MRI) related to brain volume loss(Data from the core studies through the first 5 years in this study.)
- Changes in the Magnetic Resonance Image (MRI) related to T2 lesions(Data from the core studies through the first 5 years in this study.)
- Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions(Data from the core studies through the first 5 years in this study.)
- Changes in neurofilament light change serum concentration(Data from the core studies through the first 5 years in this study.)