Relapsing Multiple Sclerosis
Conditions
Keywords
ofatumumab, relapsing multiple sclerosis
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.
Interventions
BIOLOGICALTetanus toxoid (TT) containing vaccine (Td, Tdap)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
BIOLOGICAL13-valent pneumococcal conjugate vaccine (13-PCV)
0.5mL Vial/Syringe
BIOLOGICAL23-valent pneumococcal polysaccharide vaccine (23-PPV)
0.5mL Vial/Syringe
BIOLOGICALSeasonal Quadrivalent influenza vaccine
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
BIOLOGICALKeyhole limpet hemocyanin (KLH) neo-antigen
1mg Vial
BIOLOGICALOfatumumab
subcutaneous injection of 20 mg ofatumumab every 4 weeks
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes | Up to 8 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of relapse rates per year | Data from the core studies through the first 5 years in this study. | Annual Relapse Rate (ARR) time calculated as number of confirmed relapses divided by time in study per year and will also be presented for the entire duration |
| Patients with confirmed 3 and 6 month disability worsening | During the first 5 years of treatment in the study. | A confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3, or 6 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes). |
| 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. | Confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6, 12 or 24 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes). |
| 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) | Score changes in Expanded Disability Status Scale (EDSS) over time EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes). |
| Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores | During the first 5 years of the study. | Score changes and confirmed 4-point worsening sustained for 6 months in Symbol Digit Modalities Test (SDMT) scores The Symbol Digit Modalities Test is a neuropsychological, timed test for sustained attention and concentration. 3 versions will be used, alternating at each visit where done. The number of correct responses will be counted for the score. |
| 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. | Percent change from baseline in brain volume loss (BVL) |
| Changes in the Magnetic Resonance Image (MRI) related to T2 lesions | Data from the core studies through the first 5 years in this study. | Number of new or enlarging T2 lesions |
| 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. | Total number of Gd-enhancing lesions on all MRI scans adjusted for different time of scan versus follow up time in study |
| Changes in neurofilament light change serum concentration | Data from the core studies through the first 5 years in this study. | Extent of neurofilament light change concentration in blood NfL is a component of the neuronal cytoskeleton and is released into the cerebrospinal fluid and into subsequently blood following neuro-axonal damage |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed