Title: A Mutlicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients with Secondary Progressive Multiple Sclerosis
Study Identifier: LCID: 2013-033; EXPAND
Principal Investigator: Ann Camac, MD
Purpose: To determine whether or not Siponimod (BAF312) is effective in reducing disability progression in secondary progressive multiple sclerosis (SPMS) patients as compared to Placebo.
Summary: Currently, there are no approved treatments for SPMS apart from a couple of chemo drugs with limited effectiveness. Those with SPMS have continual inflammation surrounding their injured nerve cells caused by attacks from their own immune cells, which is known to worsen disability. In this study, participants will receive either BAF312 or placebo. There is a 66% chance of receiving BAF312 and a 33% change of receiving placebo. Neither you nor your doctor will know which treatment you received. BAF312 is taken once a day. For this study, subjects will undergo a variety of examinations, including neurological exams, dermatology (skin) exams, ophthalmology (eye) exams, as well as other testing, brain MRI, and functional assessments. Participants will also be asked to complete questionnaires.
Study Type: This is a drug study. The drug involved is called Siponimod and is also known as BAF312.
Length/Duration: The study lasts for at least 2 years.
ELIGIBILITY: If you are interested in this study and want to see if you may qualify for this study, click here.
Contact: For more information on this study, please contact the study coordinator at Rik.Ganguly@Lahey.org or 781-372-7196
Title: JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri®: STRATIFY-2 Principal Investigator: Claudia Chaves, MD Sponsor: Biogen Idec Summary: This is an observational, longitudinal cohort study in patients with MS. The use of Tysabri® (natalizumab) for the treatment of multiple sclerosis (MS) has been associated with an increased risk of Progressive Multifocal Encephalopathy (PML), a rare brain infection that usually causes death or severe disability. PML is caused by a polyomavirus called the JC virus (JCV). The study aims to define the prevalence of JCV in patients with relapsing MS considering initiation of Tysabri treatment and those receiving Tysabri. All patients with relapsing MS treated with or considering treatment with Tysabri are eligible to participate.
Title: A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Principal Investigator: Claudia Chaves, MD
Sponsor: Biogen Idec., Inc
Summary: Multiple studies have demonstrated the positive effect of early therapy on patients who were in the earliest stages of relapsing remitting multiple sclerosis (RRMS). Studies have also shown that Tysabri is a potent and useful medication in reducing disability progression. The goal of this study is to determine which tests and procedures that are administered during the study course is most accurate in predicting disease free status for patients who are currently considering to take Tysabri, and who will start Tysabri as their participating in the study trial begins. The tests and procedures that will be analyzed include MRIs, physical and neurological exams, eye exams, questionnaires, and cognitive impairment tests. Patient visits occur once every months.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis
Principal Investigator: Ann Camac, MD
Summary: Individuals who suffer from SPMS are often in the later stages of Multiple Sclerosis (MS), and it is marked by increase in disability without periods of remission and independent of relapses, which is different in the case of Relapsing Remitting Multiple Sclerosis (RRMS). Patients with SPMS have continual inflammation surrounding their injured nerve cells caused by attacks from their own immune cells, which is known to worsen disability. It is thought that Tysabri might reduce inflammation by limiting the attacks by these immune cells. Currently, there are no treatment options available for individuals with SPMS. The study therefore seeks to determine whether Tysabri could be considered a potential treatment option. Subjects are to be randomized to receive either Tysabri 300 mg or placebo intravenously (IV) every 4 weeks for a 96 week period. Patient visits occur once every 12 weeks. The patient nor the study team will be aware which treatment that patient is receiving until after the study has been completed.