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)

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) - OMS112831 (MIRROR)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39973

Enrollment

Registered

2011-09-26

Start date

2012-01-11

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS mutiple sclerosis

Interventions

Treatment with ofatumumab or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * 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.

Exclusion criteria

Exclusion criteria: * 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.

Design outcomes

Primary

Measure	Time frame
Cumulative number of new T1 GdE brain lesions over 12 weeks.	—

Secondary

Measure	Time frame
Cumulative number of new T1 GdE brain lesions over 24 weeks, safety and tolerability, preliminary assessment of effect on relapses, extent of B-cell depletion, immunogenicity.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)