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Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
NCT03650114 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- 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
Study Locations (20)
Florida
- Jem Research Institute — Atlantis
- Neurology Offices of South Florida PLLC — Delray Beach
- Infinity Clinical Research LLC — Hollywood
- Homestead Assoc In Research Inc — Homestead
- Neurology Associates PA — Maitland
- UM Department Of Neurology — Miami
- Aqualane Clinical Research — Naples
- MS and Neuromuscular Center of Excellence — Oldsmar
Colorado
- CU Anschutz Med Campus — Aurora
- Mountain Neuro Research Center PC — Basalt
- Alpine Clinical Research Center — Boulder
- Colorado Springs Neurological Associates — Colorado Springs
- Colorado Neurological Research PC — Denver
- University of Colorado Health Neurology — Fort Collins
Alabama
- University of Alabama at Birmingham — Birmingham
- North Central Neurology Associates PC — Cullman
California
- Fullerton Neuro and Headache Ctr — Fullerton
- University of California Davis — Sacramento
Arizona
- Barrow Neurological Clinics at St Josephs Hospital and MC — Phoenix
Delaware
- Christiana Care Health Services — Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,882 participants |
| Start Date | 2018-12-28 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03650114
The ClinicalTrials.gov registry entry for NCT03650114 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,882 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Relapsing Multiple Sclerosis appearing as the primary indexed condition, and to 5 interventions — of which Ofatumumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03650114 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, Colorado, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03650114 about?
NCT03650114 is a clinical study titled "Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS". 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...
What is the current status of trial NCT03650114?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,882 participants. The study started on 2018-12-28. Estimated completion is 2028-09-30.
What conditions does trial NCT03650114 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03650114?
The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03650114?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03650114 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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