Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
ALITHIOS
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
2 other identifiers
interventional
1,882
35 countries
274
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2018
Longer than P75 for phase_3
274 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 28, 2018
CompletedStudy Start
First participant enrolled
December 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
May 5, 2026
May 1, 2026
9.8 years
August 17, 2018
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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.
- +4 more secondary outcomes
Other Outcomes (6)
Hummoral immune response to TT vaccine
Pre-vaccination, 4 and 8 weeks post-vaccination
Hummoral immune response to 13-valent pneumococcal conjugate vaccine (13-PCV)
4 and 8 weeks
Hummoral immune response to 13-PCV boosted eight weeks later by 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Pre-vaccination, 4 and 8 weeks post-vaccination
- +3 more other outcomes
Study Arms (1)
Ofatumumab
EXPERIMENTALSubcutaneous injection
Interventions
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
Eligibility Criteria
You may qualify if:
- Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
- Written informed consent
You may not qualify if:
- 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
- Vaccination sub-study:
- Informed consent
- Actively enrolled in the COMB157G2399 Study
- weeks of continuous treatment within the COMB157G2399 Study
- prior vaccination history as per protocol-defined
- known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
- allergies to egg or shellfish
- any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
- any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (295)
University of Alabama at Birmingham
Birmingham, Alabama, 35233-0271, United States
North Central Neurology Associates PC
Cullman, Alabama, 35058, United States
Barrow Neurological Clinics at St Josephs Hospital and MC
Phoenix, Arizona, 85013, United States
Fullerton Neuro and Headache Ctr
Fullerton, California, 92835, United States
University of California Davis
Sacramento, California, 95817, United States
CU Anschutz Med Campus
Aurora, Colorado, 80045, United States
Mountain Neuro Research Center PC
Basalt, Colorado, 81621, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Colorado Neurological Research PC
Denver, Colorado, 80210, United States
University of Colorado Health Neurology
Fort Collins, Colorado, 80528, United States
Christiana Care Health Services
Newark, Delaware, 19713, United States
Jem Research Institute
Atlantis, Florida, 33462-6608, United States
Neurology Offices of South Florida PLLC
Delray Beach, Florida, 33445, United States
Infinity Clinical Research LLC
Hollywood, Florida, 33024, United States
Homestead Assoc In Research Inc
Homestead, Florida, 33033, United States
Neurology Associates PA
Maitland, Florida, 32751, United States
UM Department Of Neurology
Miami, Florida, 33136, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
MS and Neuromuscular Center of Excellence
Oldsmar, Florida, 34677, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
Emerald Coast Neurology
Pensacola, Florida, 32514, United States
Neurostudies Inc
Port Charlotte, Florida, 33952, United States
Negroski Neurology
Sarasota, Florida, 34233, United States
Roskamp Institute Inc
Sarasota, Florida, 34243, United States
AMO Corporation
Tallahassee, Florida, 32312, United States
Clinical Research of West Florida Inc
Tampa, Florida, 33606, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
University Of South Florida
Tampa, Florida, 33612, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
Velocity Clinical Research
Savannah, Georgia, 31406, United States
Georgia Neurology and Sleep Medicine Assoc
Suwanee, Georgia, 30024, United States
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, 96817, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Consultants in Neurology
Northbrook, Illinois, 60062, United States
Josephson Wallack Munshower Neurology PC
Indianapolis, Indiana, 46256, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
College Park Family Care Center
Overland Park, Kansas, 66210, United States
Neuro Medical Clinic of Cenla LLC
Alexandria, Louisiana, 71301, United States
The Neuromedical Center
Baton Rouge, Louisiana, 70810, United States
Dragonfly Research LLC
Wellesley Hills, Massachusetts, 02481, United States
Wayne State University Multiple Sclerosis Clinic
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202-2689, United States
Vivo Infusion
Plymouth, Minnesota, 55446, United States
Sharlin Health and Neurology
Ozark, Missouri, 65721, United States
WA Uni School Of Med
St Louis, Missouri, 63110, United States
Mercy Research
St Louis, Missouri, 63141, United States
Billings Clinic
Billings, Montana, 59101, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
Cleveland Clinic Foundation
Las Vegas, Nevada, 89106, United States
University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
Ms Ctr Of Northeastern Ny
Latham, New York, 12110, United States
Asheville Neurology Specialists PA
Asheville, North Carolina, 28806, United States
The Neurological Institute PA
Charlotte, North Carolina, 28204, United States
Guilford Neurologic Associate Research
Greensboro, North Carolina, 27405, United States
Velocity Clinical Research
Raleigh, North Carolina, 27607, United States
PMG Research of Winston Salem
Winston-Salem, North Carolina, 27103, United States
Neurology and Neuroscience Assos
Akron, Ohio, 44320, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Columbus Neuroscience
Westerville, Ohio, 43082, United States
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City, Oklahoma, 73104, United States
Providence Neurological Services West
Portland, Oregon, 97225, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107-5098, United States
Abington Neurological Associates Ltd
Willow Grove, Pennsylvania, 19090, United States
Premier Neurology
Greenville, South Carolina, 29605, United States
BG Neurology
Spartanburg, South Carolina, 29303, United States
Upstate Clinical Trials LLC
Spartanburg, South Carolina, 29303, United States
Wesley Neurology Clinic
Cordova, Tennessee, 38018, United States
Tri State Mountain Neurology
Johnson, Tennessee, 37604, United States
University of Tennessee Medical Ctr
Knoxville, Tennessee, 37920, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922, United States
Med Research Inc
El Paso, Texas, 79935, United States
Neurology and Sleep Center
Lubbock, Texas, 79410, United States
Central TX Neuro Consultants P A
Round Rock, Texas, 78681, United States
Lonestar Neurology of San Antonio
San Antonio, Texas, 78258, United States
Texas Institute for Neurological Disorders
Sherman, Texas, 75092, United States
Rocky Mountain MS Clinic
Salt Lake City, Utah, 84103, United States
The University of Utah
Salt Lake City, Utah, 84132-0001, United States
Sentara Neuroscience Institute
Virginia Beach, Virginia, 23456, United States
Evergreen Health Multiple Sclerosis Center
Kirkland, Washington, 98034, United States
MultiCare Research Institute for Research and Innovation
Tacoma, Washington, 98405, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
University of Wisconsin Madison
Madison, Wisconsin, 53792, United States
Ascension St Francis Center
Milwaukee, Wisconsin, 53215, United States
St Luke s Medical Center Aurora
Milwaukee, Wisconsin, 53215, United States
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Related Publications (2)
Hauser SL, Cohen JA, de Seze J, Meuth SG, Giacomini PS, Nakahara J, Oreja-Guevara C, Robertson D, Wray S, Bhatt A, Hu X, Xi J, Piccolo R, Jehl V, Sullivan R, Boer I, Wiendl H, Kappos L. Five-Year Safety and Efficacy Outcomes with Ofatumumab in Patients with Relapsing Multiple Sclerosis. Neurol Ther. 2025 Oct;14(5):1975-1992. doi: 10.1007/s40120-025-00784-0. Epub 2025 Jul 13.
PMID: 40652442DERIVEDHauser SL, Zielman R, Das Gupta A, Xi J, Stoneman D, Karlsson G, Robertson D, Cohen JA, Kappos L. Efficacy and safety of four-year ofatumumab treatment in relapsing multiple sclerosis: The ALITHIOS open-label extension. Mult Scler. 2023 Oct;29(11-12):1452-1464. doi: 10.1177/13524585231195346. Epub 2023 Sep 11.
PMID: 37691530DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2018
First Posted
August 28, 2018
Study Start
December 28, 2018
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
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