Health Condition 1: - Health Condition 2: F82- Specific developmental disorder ofmotor function
Conditions
Interventions
Intervention1: ofatumumab 20 mg subcutaneous: pre-filled syringes for subcutaneous administration
containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content) for duration of 5 years.
Control Intervention1:
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Must have participated in a Novartis MS study a.which dosed ofatumumab 20 mg sc q4 weeks, b.was an adult (= 18 years of age) study in RMS, c.must have completed the study on study treatment 2. Written informed consent
Exclusion criteria
Exclusion criteria: 1.Premature discontinuation from previous ofatumumab study or from study treatment in previous ofatumumab study 2.Subjects that have had their previous ofatumumab study end of study(EOS) > 6 months prior to screening and/or been given another MS disease-modifying treatment (DMT) between EOS of previous study and screening of this study 3 Less than 3.5-month washout of teriflunomide for subjects that will not complete the accelerated elimination procedure (AEP) prior to Day 1. 4 Only applicable to subjects completing studies COMB157G2301 and COMB157G2302 5 Subjects with a history of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator 6 Subjects that have any unresolved adverse event (AE) or condition from the previous study that necessitates temporary interruption of the study treatment, until such time as the event or condition has resolved (the subject will be monitored within the safety follow-up of the previous study during this time) 7 Emergence of any clinically significant condition/disease during previous ofatumumab study in which study participation might result in safety risk for subjects 8 Subjects with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML 9 Subjects with active systemic bacterial, viral or fungal infections, or chronic infection (e.g. Acquired Immune Deficiency Syndrome (AIDS)) 10 Subjects that have developed or have had reactivation of syphilis or tuberculosis during previous ofatumumab study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomesTimepoint: Time Frame: Up to 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Describe long-term efficacy of ofatumumab 20 mgsc in subjects with relapsing MS (RMS)from 1st dose of ofatumumab subjects randomized to teriflunomide in COMB157G2301 and COMB157G2302& switched to ofatumumab in COMB157G2399 compare both periods before and after switch to ofatumumab Explore the long-term health outcomes in subjects with RMS treated with ofatumumab 20 mg sc from 1st dose of ofatumumab Timepoint: once q4 weeks | — |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare PVT LTD
Outcome results
None listed