An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis
- Conditions
- MSMultiple Sclerosis10029305
- Registration Number
- NL-OMON54568
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
Subjects eligible for inclusion in this study must fulfill all of the following
criteria:
- Must have participated in a Novartis MS study:
• which dosed ofatumumab 20 mg sc every 4 weeks,
• was an adult (>= 18 years of age) study in RMS,
• must have completed the study on study treatment (subjects that are on
temporary drug interruption at the time of End of Study are considered
completers).
- Written informed consent must be obtained before any assessment is performed
• 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 treatment (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 theInvestigator • Subjects that have any unresolved adverse event (AE) or
condition from the previous study or prior to Day 1 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 and not consented into study COMB157G2399 until the AE or
condition has resolved) • Emergence of any clinically significant
condition/disease during previous ofatumumab study or prior to Day 1 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)) prior to Day 1 • Subjects that have
developed or have had reactivation of syphilis, hepatitis B or tuberculosis
during previous ofatumumab study or prior to Day 1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Proportion of subjects with adverse events<br /><br>- Proportion of subjects with laboratory, or vital signs results meeting<br /><br>abnormal criteria<br /><br>-Proportion of subjects with electrocardiogram (ECG) meeting abnormal criteria<br /><br>[through Week 240 (EOS)]<br /><br>- Proportion of subjects meeting predefined criteria in Columbia Suicide<br /><br>Severity Rating Scale (C-SSRS) [through Week 240/EOS]</p><br>
- Secondary Outcome Measures
Name Time Method