Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)
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- STATUS
- Recruiting
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- End date
- Oct 3, 2028
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- participants needed
- 2010
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- sponsor
- Novartis Pharmaceuticals
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (0.5 mi away) Contact
+128 other locationSummary
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).
Details
| Condition | Relapsing Multiple Sclerosis |
|---|---|
| Treatment | Ofatumumab, Tetanus toxoid (TT) containing vaccine (Td, Tdap), 13-valent pneumococcal conjugate vaccine (13-PCV), 23-valent pneumococcal polysaccharide vaccine (23-PPV), Seasonal Quadrivalent influenza vaccine, Keyhole limpet hemocyanin (KLH) neo-antigen |
| Clinical Study Identifier | NCT03650114 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 10 March 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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