A Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months* administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) (OMS112831)
- Conditions
- MS10012303mutiple sclerosis
- Registration Number
- NL-OMON39973
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 8
* Males and females 18-55 years of age.
* Definite diagnosis of MS according to the 2010 revisions of the McDonald diagnostic criteria for MS.
* No manifestation of another type of MS other than RRMS.
* Relapsing-remitting course of disease with at least one of the following prior to screening:
A. At least one confirmed relapse within the previous year or
B. At least two confirmed relapses within the previous 2 years or
C. At least one relapse in the previous 2 years, with a GdE brain lesion on an MRI scan in the past year.
* EDSS score of 0-5.5 (inclusive) at screening.
* Neurologically stable with no evidence of relapse for at least 30 days.
* Safe contraception for women of childbearing potential.
* Unable to undergo MRI scans.
* Any clinically significant brain abnormality other than MS found on MRI.
* Neurological findings consistent with PML or confirmed PML.
* Relapse during screening.
* Prior treatment with any of the following:
A. Systemic glucocorticoids or ACTH within one month prior to screening
B. Receipt of a live vaccine within 6 weeks prior to screening
C. Glatiramer acetate or IFN-* within 3 months prior to screening
D. Any immunomodulatory therapies, excluding glatiramer acetate or IFN-*, within 6 months prior to screening
E. Any monoclonal antibodies at any time, other than natalizumab
F. Any lymphocyte-depleting therapies
G. Any immunosuppressive agents
* Chronic or ongoing active infectious disease requiring long term systemic treatment.
* Previous serious opportunistic or atypical infections.
* Positive polymerase chain reaction (PCR) screening for JC Virus.
* Positive serology for Hepatitis B.
* Prior history, or suspicion, of TB
* Known history of positive serology for HIV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cumulative number of new T1 GdE brain lesions over 12 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Cumulative number of new T1 GdE brain lesions over 24 weeks, safety and<br /><br>tolerability, preliminary assessment of effect on relapses, extent of B-cell<br /><br>depletion, immunogenicity.</p><br>