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Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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/exclusion criteria may apply.

Vaccination sub-study: Inclusion criteria. 1. Informed consent. 2. Actively enrolled in the COMB157G2399 Study. 3. 12 weeks of continuous treatment within the COMB157G2399 Study. 4. prior vaccination history as per protocol-defined. Exclusion criteria.

- 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.

Other protocol-defined inclusion/exclusion criteria may apply

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03650114
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
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, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing Multiple Sclerosis

Arms & Interventions

Arms

Experimental: Ofatumumab

Subcutaneous injection

Interventions

Biological: - Ofatumumab

subcutaneous injection of 20 mg ofatumumab every 4 weeks

Biological: - Tetanus toxoid (TT) containing vaccine (Td, Tdap)

0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid

Biological: - 13-valent pneumococcal conjugate vaccine (13-PCV)

0.5mL Vial/Syringe

Biological: - 23-valent pneumococcal polysaccharide vaccine (23-PPV)

0.5mL Vial/Syringe

Biological: - Seasonal Quadrivalent influenza vaccine

Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)

Biological: - Keyhole limpet hemocyanin (KLH) neo-antigen

1mg Vial

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35233-0271

Site Contact

Jennifer Mahaffey

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