An open-label extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with RMS
- Conditions
- Relapsing multiple sclerosis (RMS)MedDRA version: 20.0Level: PTClassification code: 10048393Term: Multiple sclerosis relapse Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-507906-15-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1889
Must have participated in a Novartis MS study: •which dosed ofatumumab 20 mg sc q4 weeks, •was an adult (= 18 years of age) study in RMS, •must have completed the study on study treatment, 2.Written informed consent
Premature discontinuation from previous ofatumumab study or from study treatment in previous ofatumumab study, 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 therapy (DMT) between EOS of previous study and screening of this study, Less than 3.5-month washout of teriflunomide for subjects that will not complete the accelerated elimination procedure (AEP) prior to Day 1. Only applicable to subjects completing studies COMB157G2301 and COMB157G2302, Subjects with a history of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator, 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 (SFU) of the previous study during this time), Emergence of any clinically significant condition/disease during previous ofatumumab study in which study participation might result in safety risk for subjects, Subjects with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML, Subjects with active systemic bacterial, viral or fungal infections, or chronic infection (e.g. Acquired Immune Deficiency Syndrome (AIDS)), Subjects that have developed or have had reactivation of syphilis or tuberculosis during previous ofatumumab study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method