• Multiple Sclerosis Trials

     

     Title: A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)  

    Study Identifier: LCID: 2014-002; ESTEEM 

    Principal Investigator: Claudia Chaves, MD

    Sponsor: Biogen Idec., Inc 

    Purpose: This study is being conducted to gain a better understanding of the benefits and risks of long-term treatment with Tecfidera in patients with multiple sclerosis (MS).  The main purpose of this observational study is to collect information on any serious side effects that may occur in patients taking Tecfidera (for example: serious infections, liver and kidney problems, cancers, and any other serious side effects). Information on relapses, disability progression, and the quality of life in patients taking Tecfidera will also be collected.  

    Summary: The safety of Tecfidera™ has been evaluated extensively in both nonclinical and clinical studies. Overall, Tecfidera™ has been shown to have an acceptable safety profile. During the development of Tecfidera™, events of interest were identified, including (but not limited to) serious and opportunistic infections (based on its putative immunomodulatory mechanism of action and its potential for reducing lymphocyte counts in humans), malignancies (based on its mechanism of action and results of the rodent carcinogenicity studies), serious hepatic events (based on its potential for elevating liver transaminases), and serious renal events (based on nonclinical data identifying the kidney as a target organ of toxicity). To date, Tecfidera™ has not been associated with an increased risk for these events compared with placebo. This study will further monitor for the occurrence of these types of events, and will provide data to characterize the safety profile of Tecfidera™ during long-term use in routine clinical practice. 

    Length/Duration: Patients will be followed for up to 5 years. Follow-up is planned regardless of whether patients do not initiate or discontinue treatment with Tecfidera™. 

    Contact: For more information on this study, please contact the study coordinator at Ramzi.Bechara@Lahey.org or 781-372-7196 

     

     

    Title: Plegridy™ (peginterferon B-1a) Real World Effectiveness and Safety Observational Program 

    Study Identifier: LCID: 2015-014; POP 

    Principal Investigator: Ann Camac, MD 

    Purpose: The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in patients with relapsing forms of MS in routine clinical practice; and to assess the overall long-term clinical effectiveness of Plegridy in patients with relapsing forms of MS in routine clinical practice. 

    Summary: In the clinical trial, treatment with Plegridy™ has demonstrated to be effective in delaying the progression of disability and in reducing the rate of clinical relapses, but it has also been associated with flu-like symptoms (FLS, including muscle aches, fever, fatigue, and chills) and injection site reactions (ISR), which are typical of interferon products. In clinical practice, pre- and post-injection treatment with acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) for the FLS is common. However, the effects of Plegridy™ did not have a negative effect on patients’ health-related quality of life compared with placebo. There is a need to continue to collect long-term data to help optimize patient management and support continued access to Plegridy in the real-world setting. 

    Length/Duration: Patients will be followed for up to 5 years. Follow-up is planned regardless of whether patients do not initiate or discontinue treatment with Plegridy. 

    Contact: For more information on this study, please contact the study coordinator at Ramzi.Bechara@Lahey.org or 781-372-7196. 

     

    Ongoing Multiple Sclerosis Clinical Trials Not Accepting New Patients

    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.

     
     

     

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