Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Public ClinicalTrials.gov record NCT03650114. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03650114
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,882 participants
Conditions and interventions
Conditions
Interventions
- 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 Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 28, 2018 (Actual)
- Primary completion
- Sep 30, 2028 (Estimated)
- Completion
- Sep 30, 2028 (Estimated)
- Last update posted
- May 27, 2026
2018 – 2028
United States locations
- U.S. sites
- 86
- U.S. states
- 32
- U.S. cities
- 77
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233-0271 | — |
| North Central Neurology Associates PC | Cullman | Alabama | 35058 | — |
| Barrow Neurological Clinics at St Josephs Hospital and MC | Phoenix | Arizona | 85013 | — |
| Fullerton Neuro and Headache Ctr | Fullerton | California | 92835 | — |
| University of California Davis | Sacramento | California | 95817 | — |
| CU Anschutz Med Campus | Aurora | Colorado | 80045 | — |
| Mountain Neuro Research Center PC | Basalt | Colorado | 81621 | — |
| Alpine Clinical Research Center | Boulder | Colorado | 80301 | — |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | 80907 | — |
| Colorado Neurological Research PC | Denver | Colorado | 80210 | — |
| University of Colorado Health Neurology | Fort Collins | Colorado | 80528 | — |
| Christiana Care Health Services | Newark | Delaware | 19713 | — |
| Jem Research Institute | Atlantis | Florida | 33462-6608 | — |
| Neurology Offices of South Florida PLLC | Delray Beach | Florida | 33445 | — |
| Infinity Clinical Research LLC | Hollywood | Florida | 33024 | — |
| Homestead Assoc In Research Inc | Homestead | Florida | 33033 | — |
| Neurology Associates PA | Maitland | Florida | 32751 | — |
| UM Department Of Neurology | Miami | Florida | 33136 | — |
| Aqualane Clinical Research | Naples | Florida | 34105 | — |
| MS and Neuromuscular Center of Excellence | Oldsmar | Florida | 34677 | — |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174 | — |
| Emerald Coast Neurology | Pensacola | Florida | 32514 | — |
| Neurostudies Inc | Port Charlotte | Florida | 33952 | — |
| Negroski Neurology | Sarasota | Florida | 34233 | — |
| Roskamp Institute Inc | Sarasota | Florida | 34243 | — |
| AMO Corporation | Tallahassee | Florida | 32312 | — |
| Clinical Research of West Florida Inc | Tampa | Florida | 33606 | — |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | — |
| University Of South Florida | Tampa | Florida | 33612 | — |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | — |
| Velocity Clinical Research | Savannah | Georgia | 31406 | — |
| Georgia Neurology and Sleep Medicine Assoc | Suwanee | Georgia | 30024 | — |
| Hawaii Pacific Neuroscience LLC | Honolulu | Hawaii | 96817 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Consultants in Neurology | Northbrook | Illinois | 60062 | — |
| Josephson Wallack Munshower Neurology PC | Indianapolis | Indiana | 46256 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| College Park Family Care Center | Overland Park | Kansas | 66210 | — |
| Neuro Medical Clinic of Cenla LLC | Alexandria | Louisiana | 71301 | — |
| The Neuromedical Center | Baton Rouge | Louisiana | 70810 | — |
| Dragonfly Research LLC | Wellesley Hills | Massachusetts | 02481 | — |
| Wayne State University Multiple Sclerosis Clinic | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202-2689 | — |
| Vivo Infusion | Plymouth | Minnesota | 55446 | — |
| Sharlin Health and Neurology | Ozark | Missouri | 65721 | — |
| WA Uni School Of Med | St Louis | Missouri | 63110 | — |
| Mercy Research | St Louis | Missouri | 63141 | — |
| Billings Clinic | Billings | Montana | 59101 | — |
| Advanced Neurology Specialists | Great Falls | Montana | 59405 | — |
| Cleveland Clinic Foundation | Las Vegas | Nevada | 89106 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131-0001 | — |
| Ms Ctr Of Northeastern Ny | Latham | New York | 12110 | — |
| Asheville Neurology Specialists PA | Asheville | North Carolina | 28806 | — |
| The Neurological Institute PA | Charlotte | North Carolina | 28204 | — |
| Guilford Neurologic Associate Research | Greensboro | North Carolina | 27405 | — |
| Velocity Clinical Research | Raleigh | North Carolina | 27607 | — |
| PMG Research of Winston Salem | Winston-Salem | North Carolina | 27103 | — |
| Neurology and Neuroscience Assos | Akron | Ohio | 44320 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | — |
| Columbus Neuroscience | Westerville | Ohio | 43082 | — |
| Multiple Sclerosis Center of Excellence of OMRF | Oklahoma City | Oklahoma | 73104 | — |
| Providence Neurological Services West | Portland | Oregon | 97225 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107-5098 | — |
| Abington Neurological Associates Ltd | Willow Grove | Pennsylvania | 19090 | — |
| Premier Neurology | Greenville | South Carolina | 29605 | — |
| BG Neurology | Spartanburg | South Carolina | 29303 | — |
| Upstate Clinical Trials LLC | Spartanburg | South Carolina | 29303 | — |
| Wesley Neurology Clinic | Cordova | Tennessee | 38018 | — |
| Tri State Mountain Neurology | Johnson | Tennessee | 37604 | — |
| University of Tennessee Medical Ctr | Knoxville | Tennessee | 37920 | — |
| Sibyl Wray MD Neurology PC | Knoxville | Tennessee | 37922 | — |
| Med Research Inc | El Paso | Texas | 79935 | — |
| Neurology and Sleep Center | Lubbock | Texas | 79410 | — |
| Central TX Neuro Consultants P A | Round Rock | Texas | 78681 | — |
| Lonestar Neurology of San Antonio | San Antonio | Texas | 78258 | — |
| Texas Institute for Neurological Disorders | Sherman | Texas | 75092 | — |
| Rocky Mountain MS Clinic | Salt Lake City | Utah | 84103 | — |
| The University of Utah | Salt Lake City | Utah | 84132-0001 | — |
| Sentara Neuroscience Institute | Virginia Beach | Virginia | 23456 | — |
| Evergreen Health Multiple Sclerosis Center | Kirkland | Washington | 98034 | — |
| MultiCare Research Institute for Research and Innovation | Tacoma | Washington | 98405 | — |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | — |
| University of Wisconsin Madison | Madison | Wisconsin | 53792 | — |
| Ascension St Francis Center | Milwaukee | Wisconsin | 53215 | — |
| St Luke s Medical Center Aurora | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 209 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03650114, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 27, 2026 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03650114 live on ClinicalTrials.gov.