Multiple Sclerosis

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment

MS is a disabling neurological disease with a highly variable clinical course including acute disability (relapses when symptoms appear or worsen) and disease progression (steady accumulation of disability in the absence of relapses). There is currently no approved treatment for progressive MS. A principal pathology of MS is the destruction of myelin, which surrounds nerves to speed up signal conduction. We have developed a magnetic resonance imaging technique that provides quantitative measurements of myelin.

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis.

This is an exploratory biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-Cell biology in relapsing multiple sclerosis (RMS). 

This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid [TT], 23-valent pneumococcal polysaccharide vaccine [23-PPV], influenza vaccine, and keyhole limpet hemocyanin [KLH]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS.

Primary Objective:

• To evaluate long-term safety of alemtuzumab.

Secondary Objectives:

• To evaluate long term efficacy of alemtuzumab. To evaluate the safety profile of patients who received other Disease Modifying Treatment's (DMT) following alemtuzumab treatment.
• To evaluate patient-reported Quality of Life (QoL) outcomes and health resource utilization of patients who received alemtuzumab.
• To evaluate as needed re-treatment with alemtuzumab and other DMTs.

This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis. Patients will be randomized to receive either in group A, ocrelizumab 600 mg intravenously (iv) every 24 weeks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, Rebif 8.8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc three times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.

The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401).

The secondary objectives of this study in this study population are as follows:

This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment.

The purpose of this study is to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study will combine all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that will provide patients with continuous treatment and will continue until fingolimod is registered, commercially available, and reimbursed in the respective countries.