A Phase 3 interventional study of Ofatumumab and Tetanus toxoid (TT) containing vaccine (Td, Tdap) in Relapsing Multiple Sclerosis, sponsored by Novartis Pharmaceuticals. Active, not recruiting at 295 sites in 37 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Vaccination sub-study:
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Subcutaneous injection
Biological: Ofatumumab · Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap) · Biological: 13-valent pneumococcal conjugate vaccine (13-PCV) · Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV) · Biological: Seasonal Quadrivalent influenza vaccine · Biological: Keyhole limpet hemocyanin (KLH) neo-antigen
subcutaneous injection of 20 mg ofatumumab every 4 weeks
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
0.5mL Vial/Syringe
0.5mL Vial/Syringe
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
1mg Vial
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
Number of relapse rates per year
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
Time frame: Data from the core studies through the first 5 years in this study.
Patients with confirmed 3 and 6 month disability worsening
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).
Time frame: 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.
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).
Time frame: During the first 5 years of treatment in the study.
Patients with changes in Expanded Disability Status Scale (EDSS) scores
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).
Time frame: 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
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.
Time frame: During the first 5 years of the study.
Changes in the Magnetic Resonance Image (MRI) related to brain volume loss
Percent change from baseline in brain volume loss (BVL)
Time frame: Data from the core studies through the first 5 years in this study.
Changes in the Magnetic Resonance Image (MRI) related to T2 lesions
Number of new or enlarging T2 lesions
Time frame: 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
Total number of Gd-enhancing lesions on all MRI scans adjusted for different time of scan versus follow up time in study
Time frame: Data from the core studies through the first 5 years in this study.
Changes in neurofilament light change serum concentration
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
Time frame: Data from the core studies through the first 5 years in this study.
Hummoral immune response to TT vaccine
Proportion of subjects with a positive antibody response to TT vaccine measured 4 and 8 weeks after vaccination while treated with ofatumumab * 2-fold increase in titer level * Tetanus anti-bodies ≥ 0.2 IU/mL * Mean titers of anti-tetanus antibody
Time frame: Pre-vaccination, 4 and 8 weeks post-vaccination
Hummoral immune response to 13-valent pneumococcal conjugate vaccine (13-PCV)
Proportion of subjects with a positive antibody response against individual anti-pneumococcal antibody serotypes while treated with ofatumumab * 2-fold increase in titer level or a \> 1 microgram/mL rise in titer compared with pre-immunization titer * Positive anti-body response against at least 2 of the 13 pneumococcal antibody serotypes * Positive anti-body response against at least 50% of serotypes * Mean titers of anti-pneumococcal antibody
Time frame: 4 and 8 weeks
Hummoral immune response to 13-PCV boosted eight weeks later by 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Proportion of subjects with a positive antibody response against individual anti-pneumococcal antibody serotypes (23 serotypes to be tested individually) measured 4 and 8 weeks after the booster 23-PPV while the subject continues to be treated with ofatumumab * 2-fold increase in titer level or a \> 1 microgram/mL rise in titer compared with pre-immunization titer * Positive anti-body response against at least 2 of the 23 pneumococcal antibody serotypes * Positive anti-body response against at least 50% of serotypes * Mean titers of anti-pneumococcal antibody
Time frame: Pre-vaccination, 4 and 8 weeks post-vaccination
Humoral immune response to KLH neo-antigen
Mean titers of anti-KLH antibody measured immediately prior the first administration of KLH and measured immediately prior to the first administration, 4, 8 and 12 weeks after the first administration, and measured 4 weeks post last administration of KLH
Time frame: Pre-administration, 4, 8, 12 weeks after initial administration and 4 weeks after last administration
Hummoral immune response to 2020-2021 seasonal quadrivalent influenza vaccine
Proportion of subjects fulfilling: 1. Seroconversion: The pre-vaccination HI antibody titer is \< 1:10 and the postvaccination measurement is ≥ 1:40 (this applies to subjects with a pre-vaccination HI titer \< 1:10), or 2. Significant increase in HI antibody titer: The pre-vaccination HI antibody titer is ≥ 1:10 and the increase from the pre- to the post-vaccination measurement is ≥ 4-fold (this applies to subjects with a pre-vaccination HI titer ≥ 1:10)
Time frame: Pre-vaccination and 4 weeks post-vaccination
Antibody response rate to TT and influenza vaccination as a function of exposure to ofatumumab
Immune response to TT and influenza vaccination
Time frame: 8 weeks
Showing the first 100 of 295 sites across 37 countries.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals