LSIS Feed - Rebif / Interferon beta-1a from 10.05.2012 This is the RSS news feed of one of our preset news channels on LSIS - The Life Science Infromation Service. Please visit us to find a current view of this one and many more channels via our alerting push services: http://www.lsis.com/channels/?query=299 http://www.lsis.com/goto/r299/rss 2012-05-10T11:12:56+01:00 text/html http://www.clinicaltrials.gov ClinicalTrials.gov 06.04.2010 | ClinicalTrials.gov: An Observational Study to Evaluate Quality of Life (QoL) and Influence of Cognitive Status on QoL in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) During 2 Years Treatment With Rebif New Formulation (RNF) http://www.lsis.com/channels/?query=299 This is a prospective, non-interventional, multicenter study to evaluate quality of life (QoL) and influence of cognitive status on QoL in subjects with relapsing-remitting multiple sclerosis (RRMS) during two years of treatment with Rebif New Formulation (RNF). |-| Prospective, Non-interventional, Multicenter Study to Evaluate QoL and Influence of Cognitive Status on QoL in Patients With RRMS During 2 Years Treatment With RNF |-| Merck KGaA |-| Poland Medical University, Department of (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 10.06.2010 | ClinicalTrials.gov: A Postmarketing Surveillance (PMS) Study to Evaluate the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis (MS) With Interferon Beta 1a (Rebif) http://www.lsis.com/channels/?query=299 This was an open-label, multicentric, prospective, post-marketing surveillance (PMS) study on the extent to which subject compliance is influenced by use of a variable titration regimen at the start of treatment of relapsing MS with Rebif. |-| Postmarketing Surveillance Study on the Extent to Which Patient Compliance is Influenced by Use of a Variable Titration Regimen at the Start of Treatment of Relapsing Multiple Sclerosis With Interferon Beta 1a (Rebif) |-| Merck KGaA text/html http://www.clinicaltrials.gov ClinicalTrials.gov 13.11.2009 | ClinicalTrials.gov: Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a (Rebif - Merck Serono) in Healthy Subjects http://www.lsis.com/channels/?query=299 The primary objective of this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN Comparator: Rebif - Merck Serono Lab) after single administration (12.000UI) in healthy subjects by modifying the parameters Cmax, Tmax and AUC (pharmacokinetics) and the levels of 2'5' oligoadenylate synthase and beta-2-microglobulin (pharmacodynamics). |-| Clinical Study of Pharmacokinetics and Pharmacodynamics (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 20.05.2009 | ClinicalTrials.gov: Efficacy and Safety Study of BIIB017 http://www.lsis.com/channels/?query=299 To determine if treatment with BIIB017 can decrease the number of MS relapses during a certain time period for patients with RMS. Other goals of the study are to determine if, over time, BIIB017 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse. |-| A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 10.06.2010 | ClinicalTrials.gov: An Observational Study to Document the Effectiveness and Compatibility of Rebif 44 or 22 g in the Therapy of the Chronic Multiple Sclerosis http://www.lsis.com/channels/?query=299 The aim of this case series was to document the effectiveness and compatibility of Rebif 44 or 22 g in the therapy of the chronic multiple sclerosis (MS) under practical conditions on a large collection of subjects. In addition, the side effects possibly occurring in the initial phase of therapy and satisfaction of the subject as well as the treating doctor was also documented. |-| Therapy of the Chronic Multiple Sclerosis With Interferon-beta 1a (Rebif) |-| Merck KGaA, GKM Gesellschaft (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 21.09.2010 | ClinicalTrials.gov: Retrospective Cohort Study of Rebif Use in Pediatric MS Patients http://www.lsis.com/channels/?query=299 The aim of this study is to review and describe safety, tolerability and efficacy of Rebif (sc IFN-beta-1a) in children and adolescents, using information already recorded in medical records. The study period is May 1998 to December 2009. |-| Retrospective Cohort Study of Rebif Use in Pediatric MS Patients |-| EMD Serono |-| United States, Alabama Research Site Birmingham, Alabama, United States United States, California Research Site San Francisco, California, United States United States, (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 10.03.2011 | ClinicalTrials.gov: A Safety Study in Healthy Volunteers of the Single-Use Autoinjector Containing Placebo of BG9418 Interferon Beta-1a With a 25-Gauge 1-Inch Needle http://www.lsis.com/channels/?query=299 This is a single-arm, single-center study in healthy volunteers. This study is designed to evaluate the safety of IM injections using single-use autoinjectors with a 25G 1 needle. The purpose of this study is not to evaluate study treatment; therefore, all injections will be performed with Avonex placebo only; no active IFN-1a will be administered. |-| A Safety Study in Healthy Volunteers of the Single-Use Autoinjector Containing Placebo of BG9418 Interferon Beta-1a With a 25-Gauge 1-Inch (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 16.04.2009 | ClinicalTrials.gov: A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis http://www.lsis.com/channels/?query=299 The primary objective is to assess the effectiveness of 2 doses of teriflunomide in comparison to interferon beta-1a in patients with patients with relapsing multiple sclerosis. A secondary objective is to evaluate the safety and tolerability of 2 doses of Teriflunomide in comparison to interferon beta-1a. |-| A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 24.02.2010 | ClinicalTrials.gov: A Pilot Trial of Interferon Beta-1a in Alzheimer's Disease http://www.lsis.com/channels/?query=299 This was a 52-week, multicentric, phase II, pilot study conducted in 40 subjects with early-onset Alzheimer's disease (AD) to evaluate safety, tolerability and clinical efficacy of subcutaneous (sc) interferon (IFN) beta-1a [Rebif 22 microgram (mcg), three times per week (tiw)] in the treatment of AD by comparing the neuropsychological performance changes into placebo and treatment arms from screening/baseline to 52 week. |-| Pilot Trial of Interferon Beta-1a in Alzheimer's Disease |-| Merck (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 18.12.2009 | ClinicalTrials.gov: A Multicenter, Open-label, RebiSmart Autoinjector Ease of Use Study http://www.lsis.com/channels/?query=299 The purpose of this study is to test the RebiSmart for ease of use multiple domains related to subject's acceptability and satisfaction reliability of the correct function for self-injection of Rebif 44 mcg sc tiw in subjects with RMS. |-| A Twelve-week, Phase IIIb, Open-label, Single-arm, Multicenter Trial to Evaluate Ease of Use of an Electronic Autoinjector (RebiSmart) for Self-injection in Subjects With Relapsing Multiple Sclerosis (RMS) Treated With Rebif 44mcg Subcutaneously (sc) (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 02.06.2009 | ClinicalTrials.gov: Immunogenicity and Safety Study of Serum-Free Avonex http://www.lsis.com/channels/?query=299 To evaluate the immunogenicity of a serum-free pre-formulated solution of Avonex when given to interferon beta naive patients with relapsing/remitting multiple sclerosis. |-| A Multicenter, Open-Label Immunogenicity and Safety Study of a Serum-Free Pre-Formulated Solution of AVONEX (Interferon Beta-1a) Administered Intramuscularly to Patients With Relapsing/Remitting Multiple Sclerosis |-| Biogen Idec text/html http://www.clinicaltrials.gov ClinicalTrials.gov 05.06.2009 | ClinicalTrials.gov: Open-Label Safety Extension Study of Avonex http://www.lsis.com/channels/?query=299 To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS. |-| An Open-Label Safety Extension Study of AVONEX (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830 |-| Biogen Idec text/html http://www.clinicaltrials.gov ClinicalTrials.gov 02.09.2009 | ClinicalTrials.gov: Herbal Therapy for Subcutaneous Injection Site Reactions in Multiple Sclerosis http://www.lsis.com/channels/?query=299 The purpose of this study is to determine if an herbal over-the-counter cream can decrease skin site reactions in multiple sclerosis patients who currently take either Betaseron, Copaxone or Rebif as their subcutaneous medication for managing their multiple sclerosis. Injection site reactions have been indicated as one of the major reasons for discontinuing treatment with the subcutaneous medications (Betaseron, Copaxone, and Rebif) for multiple sclerosis. |-| Herbal Therapy for Subcutaneous (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 02.06.2009 | ClinicalTrials.gov: Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers http://www.lsis.com/channels/?query=299 This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a. |-| A Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX, MS Subjects Naïve to Treatment, and Healthy Control Subjects |-| Biogen Idec text/html http://www.clinicaltrials.gov ClinicalTrials.gov 31.08.2010 | ClinicalTrials.gov: Assessment of Patient Use of a New Device: RebiSmart http://www.lsis.com/channels/?query=299 Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the nerves in within the brain and the spinal cord. This disease is one of the most common causes of disability in young adults. A 'relapse' is a phenomenon that occurs when there is an acute attack of disability as a result of an acute attack on the nervous system. There is usually some degree of recovery after a relapse. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 26.04.2010 | ClinicalTrials.gov: An Observational Study for the Assessment of Compliance and Persistence to Rebif Therapy of Patients With Relapsing-remitting Multiple Sclerosis (MS) and Evaluation of Potential Factors Influencing These Parameters http://www.lsis.com/channels/?query=299 The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif) and at investigating potential factors that are involved in its outcome, in a representative sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life conditions. |-| A Multicentre, Non Interventional, Non Randomized, Observational Study for the Assessment of Compliance and Persistence With Rebif Therapy of Patients With Relapsing-Remitting Multiple Sclerosis as Well as (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 22.02.2010 | ClinicalTrials.gov: Tolerability of Rebif (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis http://www.lsis.com/channels/?query=299 This is an observational study to assess the tolerability of Rebif treatment in Korean multiple sclerosis (MS) subjects. |-| A Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif) Therapy for Korean Patients With Multiple Sclerosis |-| Merck KGaA |-| Korea, Republic of Samsung Medical Center Seoul, 50 Ilwon-dong, Gangnam-gu, Korea, Republic of text/html http://www.clinicaltrials.gov ClinicalTrials.gov 10.06.2010 | ClinicalTrials.gov: A Phase IV Study of Rebif 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone http://www.lsis.com/channels/?query=299 In the course of therapy escalation, the multiple sclerosis (MS) subjects with high activity of disease receive mainly mitoxantrone. The duration of therapy is limited because of a cumulative dose for life (140 mg/m^2 body surface area). In practice lower doses of mitoxantrone (60-120 mg/m^2 body surface area) are being used. The specific reason for this limited total dose are potential cardiotoxic side effects of mitoxantrone. Once this cumulative dose of mitoxantrone is reached and the (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 20.05.2010 | ClinicalTrials.gov: Treatment Adherence When Using RebiSmart in Relapsing Multiple Sclerosis Subjects http://www.lsis.com/channels/?query=299 This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart for self-injection of Rebif in subjects with relapsing multiple sclerosis (RMS). Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart) to inject Rebif for 96 weeks. The main purpose of this (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 17.01.2012 | ClinicalTrials.gov: Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a http://www.lsis.com/channels/?query=299 This is a prospective, monocentric, double blind, placebo controlled, two arm study. Curcumin is derived from the rhizomes of the plant Curcuma longa (common name, turmeric) belonging to the Zingiberaceae family found in South Asian countries, especially India which is the largest producer. BCM95 (bioCurcumin) is a combination of a Curcumin extract and oil to enhance the bio-absorbability in humans. BCM95 may enhance and prolong the antioxidant and anti-inflammatory effects of the standard (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 02.06.2009 | ClinicalTrials.gov: A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers http://www.lsis.com/channels/?query=299 Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex. |-| A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of AVONEX (Interferon Beta-1a) Solutions for Injection Produced by a Serum-Containing Manufacturing Process and by a Serum-Free Manufacturing Process |-| Biogen Idec text/html http://www.clinicaltrials.gov ClinicalTrials.gov 29.10.2008 | ClinicalTrials.gov: Immunogenicity and Safety of Subcutaneously-Administered Avonex (Interferon Beta 1-a) in Multiple Sclerosis (MS) Subjects http://www.lsis.com/channels/?query=299 This study is being conducted to determine the immunogenicity and safety of Avonex (Interferon Beta 1-a) 30 mcg when administered subcutaneously (SC) once weekly to interferon-naive subjects. |-| A Phase 3, Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex (Interferon Beta-1a) 30 Mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis |-| Biogen Idec |-| United States, Texas MS Center at Texas Neurology Dallas, Texas, United States, 75214 text/html http://www.clinicaltrials.gov ClinicalTrials.gov 03.06.2009 | ClinicalTrials.gov: Comparison of Campath and Rebif Treatment on Cognition in Multiple Sclerosis (MS) http://www.lsis.com/channels/?query=299 People with multiple sclerosis (MS) often experience problems with cognitive functioning, which can be debilitating and interfere with their daily functioning. However, research has shown that MS disease modifying agents have had some success in treating cognitive problems. The main purpose of this research study is to investigate how well two medicines (alemtuzumab (Campath) and interferon beta-1a (Rebif) work in treating MS-related cognitive problems (e.g., attention, memory, speed of (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 07.10.2008 | ClinicalTrials.gov: A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a http://www.lsis.com/channels/?query=299 Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRIÂ) or Interferon beta-1a (AVONEXÂ) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS). |-| Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 03.03.2010 | ClinicalTrials.gov: Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis http://www.lsis.com/channels/?query=299 This 1-arm, open-label, multicentric, observational study aims to collect subject centric information in line with routine care. Subjects' expectations of therapy, side effect management and lifestyle may influence adherence to therapy. This survey aims to determine whether such factors and/or others affect the successful initiation and maintenance of Rebif therapy. The data collected during this study will include information on the subject's treatment including expectations, experience, (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 17.05.2010 | ClinicalTrials.gov: A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects http://www.lsis.com/channels/?query=299 The primary objective is to determine adherence to Rebif New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS. |-| A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects: the ScanSmart Study |-| Merck KGaA, Merck Serono Norway, Smerud Medical Research International AS |-| Norway Sandvika Nevrosenter Recruiting Sandvika, Sandviksveien (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 26.06.2009 | ClinicalTrials.gov: An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab http://www.lsis.com/channels/?query=299 This open-label, rater-blinded extension study will enroll patients who have relapsing-remitting multiple sclerosis (RRMS) and who participated in one of three prior Genzyme-sponsored studies of alemtuzumab [CAMMS223 (NCT00050778), CAMMS323 (NCT00530348) also known as CARE-MS I, or CAMMS324 (NCT00548405) also known as CARE-MS II]. The purposes of this study are: To examine the long term safety and efficacy of alemtuzumab treatment in patients who received alemtuzumab as their study treatment (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 09.06.2009 | ClinicalTrials.gov: The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis http://www.lsis.com/channels/?query=299 This study is designed to evaluate the neuroprotective effect of lamotrigine in the combination of interferon beta 1a once weekly intramuscular in patients with relapsing-remitting multiple sclerosis. |-| Randomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis. |-| Cantonal Hospital of St. Gallen |-| Switzerland Cantonal Hospital St. (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 11.01.2008 | ClinicalTrials.gov: Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis http://www.lsis.com/channels/?query=299 The purpose of this study is to find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis. |-| A Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX and Rebif to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS) |-| Biogen Idec |-| United States, California Research Site Los Angeles, California, United States Research Site Walnut Creek, California, (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 09.06.2010 | ClinicalTrials.gov: An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif Therapy http://www.lsis.com/channels/?query=299 Significant data from placebo-controlled clinical trials have demonstrated the efficacy of Rebif in relapsing remitting multiple sclerosis (RRMS) with reduction in relapse rate, delay in disability progression, and reduction in magnetic resonance imaging (MRI) activity and accumulation of lesion burden. Multiple sclerosis (MS), a chronic neurological diseases, can have diverse effects on the lives of subjects and their families. In controlled clinical trials, clinical measurement in MS has (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 13.01.2010 | ClinicalTrials.gov: Clinical 15 Months Study Comparing Monthly Pulse ACTH (Acthar Gel) Therapy With Monthly Methylprednisolone (MP, Solumedrol) for Multiple Sclerosis (MS) Patients Who Are on Regular Beta-interferons (Avonex, Betaseron or Rebif) http://www.lsis.com/channels/?query=299 We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as Acthar Gel (MANUFACTURER NAME) is effective in the control of clinical disease activity as a pulse therapy for relapsing-remitting MS when added to standard treatment with beta-interferon. We wish to determine whether ACTH, when administered as clustered monthly intramuscular injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective alternative to monthly pulse (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 10.06.2010 | ClinicalTrials.gov: An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif) in Multiple Sclerosis (MS) Patients http://www.lsis.com/channels/?query=299 This was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects. |-| Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif) in MS Patients. Case Series for Adjustment of (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 31.08.2010 | ClinicalTrials.gov: Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration http://www.lsis.com/channels/?query=299 Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections. Prior to treatment, patients receive training on the use of the (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 09.12.2009 | ClinicalTrials.gov: Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15) http://www.lsis.com/channels/?query=299 This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial. The aim of this trial is to provide additional data on the driving factors of IFN beta response and the long-term outcomes of Rebif treatment. This is a Phase IV trial involving subjects who previously participated in the PRISMS trial. To address the trial objectives, a single (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 08.09.2010 | ClinicalTrials.gov: A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 g 3 Times Weekly http://www.lsis.com/channels/?query=299 The aim of this multicentre, randomised, double-blind, placebo-controlled study is to evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3) in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.) interferon beta-1a 44 g (Rebif) 3 times weekly. The subjects will be divided into 2 groups, one receiving cholecalciferol 100,000 IU twice monthly along with Rebif treatment and the other group will be on placebo along with Rebif (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 08.08.2011 | ClinicalTrials.gov: A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis http://www.lsis.com/channels/?query=299 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 (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 16.12.2009 | ClinicalTrials.gov: The Rebif vs Glatiramer Actetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial http://www.lsis.com/channels/?query=299 This study, REGARD-PGx is a single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Actetate in Relapsing MS Disease) trial. The aim of this trial is to provide additional data on the factors influencing IFN beta response. This is a Phase IV trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected. |-| A (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 06.05.2010 | ClinicalTrials.gov: A Study of Avonex to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers http://www.lsis.com/channels/?query=299 This is a randomized, 3-arm, dose-blinded, parallel-group study. Subjects will be randomized to one of 3 treatment titration regimes (slow titration over 6 weeks, fast titration over 3 weeks, and no titration). |-| A Randomized, Three-Arm, Dose-Blinded, Parallel-Group Study to Determine the Effect of Avonex Dose Titration on the Severity and Incidence of Interferon Beta-1a-Related Flu Like Symptoms in Healthy Volunteers |-| Biogen Idec |-| United States, Minnesota Research Site St. Paul, (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 08.04.2010 | ClinicalTrials.gov: Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting. http://www.lsis.com/channels/?query=299 This observational multicentric study is planned to assess the tolerability of Rebif New Formulation in an Australian clinical setting by the incidence of injection site reactions (ISRs). The study will allow the comparison of tolerability data with historical data for both Rebif New and classic formulations, and will do so by using the same pre- specified preferred terms of treatment emergent adverse events as done in historical studies. In addition, the study will analyse whether (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 20.10.2011 | ClinicalTrials.gov: MATRIX: Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia http://www.lsis.com/channels/?query=299 This is a cross sectional Phase 4, multicenter, study of AVONEX and JUMTAB to determine the frequency of IFN induced Neutralizing Antibodies (Nabs). A secondary component is the long term retrospective observational evaluation conducted to measure efficacy, adherence to therapy, tolerability, and safety in subjects with relapsing MS related to antibody status and treatment. |-| Measuring Neutralizing Antibodies in the Patients Treated With Interferon Beta 1a IM, in Mexico and Colombia |-| (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 06.05.2010 | ClinicalTrials.gov: A Single-Dose, PK/PD, & Safety Study of BIIB017 in Subjects With Renal Impairment & Healthy Volunteers http://www.lsis.com/channels/?query=299 This is an open-label, multicenter, non-randomized, serial-group, pharmacokinetic (PK), PD, and safety study in healthy subjects, and in subjects with renal impairment |-| An Open-Label, Single-dose, Pharmacokinetic, Pharmacodynamic, and Safety Study of PEGylated Interferon Beta-1a (BIIB017) in Healthy Subjects and Subjects With Renal Impairment |-| Biogen Idec |-| United States, Florida Research Site Orlando, Florida, United States United States, Minnesota Research Site St. Paul, Minnesota, (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 21.04.2010 | ClinicalTrials.gov: An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart. http://www.lsis.com/channels/?query=299 RebiSmart is a device with an electronic injection log to monitoring adherence to therapy. Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may improve patient satisfaction and adherence to therapy. The objectives of this study are to evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge. |-| Assessment of Adherence, Effectiveness & (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 24.02.2010 | ClinicalTrials.gov: Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif http://www.lsis.com/channels/?query=299 The study is planned to evaluate the cognitive functions in subjects with RRMS treated with interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status. |-| Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With Rebif |-| Merck KGaA, Merck spol.s.r.o., Czech Republic |-| Czech Republic Neurologicka klinika FNBB Brno, Czech Republic Neurologicka klinika, Fakultní nemocnice U Sv. Anny Brno, Czech Republic (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 06.01.2011 | ClinicalTrials.gov: Avonex-evaluation of Quality of Life and Convenience in Belgian Patients - The AVAIL Study http://www.lsis.com/channels/?query=299 A Multicenter, prospective, non-interventional study to evaluate the quality of life in Belgian patients with CIS or RRMS in whom IFN Beta-1a IM has been initiated. |-| Avonex-evaluation of Quality of Life and Convenience in Belgian Patients - The AVAIL Study |-| Biogen Idec |-| Belgium Research Site Recruiting Antwerpen, Belgium Research Site Recruiting Brabant Wallon, Belgium Research Site Recruiting Bruxelles, Belgium Research Site Recruiting Hainaut, Belgium Research Site Recruiting (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 06.02.2008 | ClinicalTrials.gov: Combination Therapy Using Cellcept and Rebif in RRMS http://www.lsis.com/channels/?query=299 The purpose of this trial is to examine the benefits of early combination of CellCept with Rebif in long-term management of patients with multiple sclerosis. Quantitation of mRNA for MxA gene from ex-vivo lymphocytes obtained from patients receiving both drugs or interferon alone will be used to gauge the usefulness of this combination therapy. In addition we will examine the safety of combination of mycophenolate mofetil and interferon beta 1a in treatment of multiple sclerosis. This is a (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 23.11.2010 | ClinicalTrials.gov: A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis http://www.lsis.com/channels/?query=299 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 (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 02.03.2010 | ClinicalTrials.gov: Safety, Tolerability and Adherence With Rebif New Formulation in Real Life Settings (STAR) http://www.lsis.com/channels/?query=299 The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif New Formulation in real life settings with a multinational approach, as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence. |-| An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif New Formulation) (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 28.05.2010 | ClinicalTrials.gov: Minocycline as add-on to Interferon Beta-1a (Rebif) in Relapsing Remitting Multiple Sclerosis http://www.lsis.com/channels/?query=299 This is a multicentric, double-blind, placebo-controlled, randomised, parallel group study to estimate the effect of minocycline as add-on to interferon beta 1a (IFN -1a) in subjects with relapsing remitting multiple sclerosis (RRMS). |-| A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Investigating Minocycline Versus Placebo as add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44mcg Tiw (Rebif) for the Treatment of Relapsing- (…) text/html http://www.clinicaltrials.gov ClinicalTrials.gov 07.04.2011 | ClinicalTrials.gov: Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis http://www.lsis.com/channels/?query=299 This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017 by measuring the nerve fiber thickness in the eye. |-| Optical Coherence Tomography (OCT) in a Multicenter, Randomized,Double-Blind, (…) text/html http://www.biospace.com BioSpace 24.04.2012 | BioSpace: Genzyme Corporation (GENZ) Release: Significant Improvement in Disability Scores Observed in Multiple Sclerosis Patients Who Received LemtradaTM* (Alemtuzumab) Compared With Rebif in Phase lll Trial http://www.lsis.com/channels/?query=299 CAMBRIDGE, Mass. April 24, 2012 Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), reports today additional data from the Phase lll CARE-MS ll trial. Accumulation of disability was significantly slowed in patients with multiple sclerosis (MS) who were treated with alemtuzumab versus Rebif (high dose subcutaneous interferon beta-1a), as measured by the Expanded Disability Status Scale (EDSS), a standard assessment of physical disability progression. In addition, significant improvement in (…)