Last updated 35 days ago
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
2060 patients around the world
Available in Argentina, Mexico, Peru
Novartis Pharmaceuticals
4Research sites
2060Patients around the world
This study is for people with
Multiple sclerosis
Relapsing remitting multiple sclerosis
Requirements for the patient
To 100 Years
All Gender
Medical requirements
- Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeksWritten informed consentInformed consentActively enrolled in the COMB157G2399 Study12 weeks of continuous treatment within the COMB157G2399 Studyprior vaccination history as per protocol-defined
- Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subjectSubjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)Subjects taking medications prohibited by the protocolPregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may applyknown hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccinesallergies to egg or shellfishany safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study startany major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit
Sites
STAT Research - CABA
Recruiting
Hospital Córdoba
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
Fundación Rosarina de Neuro-Rehabilitación - Rosario, Santa Fe
Recruiting
StudyCOMB157G2399
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
Relapsing remitting multiple sclerosis
Requirements
To 100 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03650114
