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
Study Identifier: LCID: 2011-036; ASCEND SPMS
Principal Investigator: Ann Camac, MD
Sponsor: Biogen Idec., Inc
Purpose: To determine whether or not Tysabri is effective in reducing disability progression for Secondary Progressive Multiple Sclerosis (SPMS) patients as compared to Placebo
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
Study Type: This is a drug study. The drug involved is called Tysabri by its trade name, or Natalizumab by its industry name.
Length/Duration: 108 week study duration, including 96 weeks where the patient will receive study drug. Study requires that patient be infused with study drug once a month at the infusion center here at Lahey Hospital & Medical Center. Patient will be required to come in for a screening visit to determine that all eligibility criteria has been met, and afterwards the study visits will once every 12 weeks for 108 weeks.
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: A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients
Study Identifier: LCID: 2012-001; STRIVE MS
Principal Investigator: Claudia Chaves, MD
Purpose: An observational study to determine which questionnaires and tests predict disease-free states for patients who are using Tysabri to treat early stages of Multiple Sclerosis
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.
Study Type: This is an obervational study.
Length/Duration: 48 month (4 years) study duration. Patient will be required to come in for a screening visit to determine that all eligibility criteria has been met. Please note that patients will not be receiving Tysabri as part of this trial- patients are expected to be considering to take Tysabri in order to qualify for the trial.
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.
RESEARCH IN NEUROLOGY
The American Heart Association/American Stroke Association's Get With The Guidelines program has again awarded Lahey Clinic’s stroke service the Stroke Gold Performance Achievement Award.