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Blood Adv. This article summarizes the milestones in the development of ravulizumab leading to this first approval for PNH. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening. In December 2018, intravenous ravulizumab received its first global approval in the USA for the treatment of adults with PNH, and is under regulatory review in the European Union and Japan in this indication. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Bethesda, MD 20894, Copyright Participants will receive ravulizumab for the duration of the study. Information provided by (Responsible Party): The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG). Aalborg University Hospital, Aalborg, North Jutland Region, Denmark, 9000, Marseille, Provence-Alpes-Cote d'Azur, France, 13385, Nice, Provence-Alpes-Cote d'Azur, France, 6000, Klinikum Würzburg Mitte gGmbH Standort Juliusspital, Klinik fur Neurologie, Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany, 45147, Universitatsklinikum Munster, Klinik fur Neurologie, Münster, Nordrhein-Westfalen, Germany, 48149, Charite Universitatsmedizin Berlin- NeuroCure Clinical Research Center (NCRC), University Medical Center Hamburg Eppendorf, The Tel Aviv Sourasky Medical Center (TASMC) (Ichilov Hospital), IRCCS Istituto delle Scienze Neurologiche, Azienda USL di Bologna, Ospedale Bel, Fondazione IRCCS Istituto Neurologico Carlo Besta, ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII), Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario Agos, Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza, Azienda Ospedaliera Universitaria Policlinico G. Martino, Niigata University Medical and Dental Hospital, National Hospital Organization Osaka Toneyama Medical Center, Tokyo Medical And Dental University, Medical Hospital, Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612, Kyungpook National University Chilgok Hospital, Yonsei University College of Medicine, Severance Hospital, Amsterdam, Noord-Holland, Netherlands, 1105 AZ, Leiden, Noord-Holland, Netherlands, 2333 ZA, Hospital Clinico Universitario Virgen de la Arrixaca, Hospital Universitario y Politecnico la Fe. For information on site of service for Ultomiris infusions, see Utilization Management Policy on Site of Care for Specialty Drug Infusion. Documentation of diagnosis of myasthenia gravis with a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of class II, III, or IV AND 2. Alexion is also evaluating the coadministration of subcutaneous ravulizumab with Halozyme's ENHANZE® drug-delivery technology (rHuPH20), which may have the potential to further extend the dosing interval. Your doctor will review your symptoms and your medical history and conduct a physical examination. What are some of the study details? C. GENERALIZED MYASTHENIA GRAVIS (SOLIRIS ONLY): 1. Myasthenia Gravis … To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ], Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ], Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26 [ Time Frame: Baseline, Week 26 ], Change From Baseline In The Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score of at least 3 points At Week 26 [ Time Frame: Baseline, Week 26 ], Change From Baseline In the The Quantitative Myasthenia Gravis (QMG) total score by at least 5 points At Week 26 [ Time Frame: Baseline, Week 26 ]. Please enable it to take advantage of the complete set of features! For general information, Learn About Clinical Studies. (Clinical Trial), Triple (Participant, Care Provider, Investigator). Talk with your doctor and family members or friends about deciding to join a study. Listing a study does not mean it has been evaluated by the U.S. Federal Government. -, Blood. Nat Rev Dis Primers. Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Ravulizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Epub 2020 Oct 9. Clipboard, Search History, and several other advanced features are temporarily unavailable. Why Should I Register and Submit Results? 2019 Feb 7;133(6):540-549. doi: 10.1182/blood-2018-09-876805. Kulasekararaj AG, Hill A, Rottinghaus ST, Langemeijer S, Wells R, Gonzalez-Fernandez FA, Gaya A, Lee JW, Gutierrez EO, Piatek CI, Szer J, Risitano A, Nakao S, Bachman E, Shafner L, Damokosh AI, Ortiz S, Röth A, Peffault de Latour R. Blood. a Safety and efficacy study of ravulizumab in adults with generalized myasthenia gravis (NCT03920293) b. 2020 Nov;63(11):1396-1402. doi: 10.1007/s00103-020-03229-1. eCollection 2020. -, Blood Adv. Like the first-generation C5 inhibitor, eculizumab, ravulizumab binds specifically and with high affinity to the complement protein C5, thereby preventing formation of the terminal complement complex C5b-9, which mediates cell lysis. eCollection 2019. The use of ravulizumab in myasthenia gravis and IgA nephropathy is also being evaluated in the USA in early-phase and preclinical studies, respectively. -, PLoS One. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria. doi: 10.1371/journal.pone.0241989. Monoclonal Antibodies Capable of Inhibiting Complement Downstream of C5 in Multiple Species. Documentation of a Myasthenia Gravis … 2019 Sep 10;10:2040620719874728. doi: 10.1177/2040620719874728. Choosing to participate in a study is an important personal decision. Note: Site of Care Utilization Management Policy applies. Your doctor might use several tests, including: Myasthenia gravis (MG) is a common autoimmune disorder of the neuromuscular junctions. Epub 2018 Dec 3. Clinical development of a subcutaneous formulation for PNH and aHUS is also underway. Sarkar C, Mondal M, Torequl Islam M, Martorell M, Docea AO, Maroyi A, Sharifi-Rad J, Calina D. Front Pharmacol. Ravulizumab: a novel C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria. Myasthenia gravis (MG) is the prototypical autoimmune disorder caused by specific autoantibodies at the neuromuscular junction. 8600 Rockville Pike 2018 Apr 12;13(4):e0195909 FOIA 2020 Dec 10;11:612402. doi: 10.3389/fimmu.2020.612402. The autoantibodies cause morphological and functional changes in the postsynaptic membrane, resulting in symptoms of fatigable weakness of skeletal muscles. COVID-19 is an emerging, rapidly evolving situation. PLoS One. It's caused by a breakdown in the normal communication between nerves and muscles.There's no cure for myasthenia gravis, but treatment can help relieve signs and symptoms, such as weakness of arm or leg muscles, double vision, drooping eyelids, and difficulties with sp… Study record managers: refer to the Data Element Definitions if submitting registration or results information. Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab. Potential Therapeutic Options for COVID-19: Current Status, Challenges, and Future Perspectives. Ravulizumab-cwvz (Ultomiris) Reauthorization Criteria. Myasthenia gravis is a chronic autoimmune, neuromuscular disease that causes weakness in the skeletal muscles that worsens after periods of activity and improves after periods of … Characteristics of and meningococcal disease prevention strategies for commercially insured persons receiving eculizumab in the United States. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening. 2019 Jun;71(6):555-564. doi: 10.11477/mf.1416201316. Generalized myasthenia gravis (MG), a disorder that leads to muscle weakness If You Take a Complement Inhibitor, You Are at High Risk for Meningococcal Disease Even if Vaccinated … Participants who have received previous treatment with complement inhibitors (for example, eculizumab). Broad-based immunotherapies, such as corticosteroids, azathioprine, mycophenolate, tacrolimus, and cyclosporine, have been effective in controlling symptoms of myasthenia… 2018 Sep 11;2(17):2176-2185 Myasthenia gravis (MG) is an autoantibody and complement mediated autoimmune disease. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1). Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight. Röth A, Rottinghaus ST, Hill A, Bachman ES, Kim JS, Schrezenmeier H, Terriou L, Urbano-Ispizua Ã, Wells RA, Jang JH, Kulasekararaj AG, Szer J, Aguzzi R, Damokosh AI, Shafner L, Lee JW. Brain Nerve. Unable to load your collection due to an error, Unable to load your delegates due to an error. 2021 Feb 25;150:112087. doi: 10.1016/j.fct.2021.112087. 2018 Sep 11;2(17):2176-2185. doi: 10.1182/bloodadvances.2018020644. Eculizumab, a drug that blocks the complement cascade, is safe and effective in reducing symptoms in patients with generalized myasthenia gravis (gMG) who have not responded to the … Ultomiris™ (ravulizumab-cwvz) – New orphan drug approval • On December 21, 2018, the FDA announced the approval of Alexion Pharmaceuticals’ Ultomiris ... and generalized myasthenia gravis… Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. National Library of Medicine One of Alexion’s medications is Soliris (eculizumab), which is approved in the U.S. and the EU for the treatment of generalized myasthenia gravis (gMG), atypical haemolytic uremic … Eculizumab is the first drug approved for refractory- myasthenia gravis, that constitutes 10–15% of myasthenia gravis patients, based on encouraging results in a phase-2 study that led to phase-III … The use of ravulizumab in myasthenia gravis and IgA nephropathy is also being evaluated in the USA in early-phase and preclinical studies, respectively. Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies. 2017 May 18;3:17028 Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Phase 3 development of intravenous ravulizumab for the treatment of aHUS is underway worldwide. Any active or untreated thymoma. Myasthenia Gravis (MG) ID: NCT03920293 Alexion is conducting a clinical study which will evaluate the safety and effectiveness of ravulizumab-cwvz in treating patients with myasthenia gravis (MG) For precertification of ravulizumab-cwvz, call (866) 752-7021, or fax (866) 267-3277. Expert Opin Biol Ther. of Neurology. eCollection 2020. The use of ravulizumab in myasthenia gravis and IgA nephropathy is also being evaluated in the USA in early-phase and preclinical studies, respectively. You have reached the maximum number of saved studies (100). eCollection 2020. Overview This is a phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluates using ravulizumab infusions as treatment for patients with generalized Myasthenia Gravis. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight. [Monoclonal antibodies for anti-infective therapy]. Prevention and treatment information (HHS). Careers. This site needs JavaScript to work properly. Online ahead of print. ... Myasthenia Gravis. Ravulizumab-cwvz is currently not FDA approved for use in myasthenia gravis. To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL profile. Ravulizumab (ravulizumab-cwvz; ULTOMIRISâ¢), a humanized monoclonal antibody, is a complement C5 inhibitor developed by Alexion Pharmaceuticals for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). The humanized monoclonal antibody eculizumab (Soliris®) is a complement inhibitor indicated for use in anti-acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis … Documentation of Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV generalized myasthenia gravis AND 4. a Safety and efficacy study of ravulizumab in adults with generalized myasthenia gravis (NCT03920293) Front Immunol. Clinical development of a subcutaneous formulation for PNH and aHUS is also underway. IV immunoglobulin within 4 weeks of randomization, Use of plasma exchange within 4 weeks of randomization, Use of rituximab within 6 months of screening. Ravulizumab (ALXN 1210) is a humanised anti-C5 antibody, being developed by Alexion Pharmaceuticals utilising the Xencor's Xtend™ technology, as intravenous and A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia … Myasthenia gravis (my-us-THEE-nee-uh GRAY-vis) is characterized by weakness and rapid fatigue of any of the muscles under your voluntary control. Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Inflammation, immunity and potential target therapy of SARS-COV-2: a total scale analysis review. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920293. 2020 Nov 12;15(11):e0241989. Clinical development of a subcutaneous formulation for PNH and aHUS is also underway. -, Blood. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Please remove one or more studies before adding more. Epub 2020 Feb 14. Ther Adv Hematol. 2020 Mar;20(3):227-237. doi: 10.1080/14712598.2020.1725468. -. 2019 Feb 7;133(6):530-539 Read our, ClinicalTrials.gov Identifier: NCT03920293, Interventional
Use of the following within the time period specified below: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Ravulizumab, which is administered every 8 weeks versus every 2 weeks for eculizumab, has already gained approval for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), and Alexion is studying the drug in patient … A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis, 18 Years and older (Adult, Older Adult), St. Joseph's Hospital and Medical Center (SJHMC)-Barrow Neurological Institute (BNI), Phoenix, Arizona, United States, 85013-4409, Honor Health Neurology/Phoenix Neurological Associates Ltd. PNA, Loma Linda, California, United States, 92354, Los Angeles, California, United States, 90048, Palo Alto, California, United States, 94304, San Francisco, California, United States, 94109, Colorado Springs, Colorado, United States, 80907, Fort Collins, Colorado, United States, 80528, New Haven, Connecticut, United States, 06510, Washington, District of Columbia, United States, 20007, Clearwater, Florida, United States, 33761, University of Florida Health at Jacksonville, Jacksonville, Florida, United States, 32209, University of South Florida - Carol & Frank Morsani Center for Advanced Healthcare, The University of Chicago - The Center for Peripheral Neuropathy, Rolling Meadows, Illinois, United States, 60008, Indianapolis, Indiana, United States, 46202, Lexington, Kentucky, United States, 40503, Lexington, Kentucky, United States, 40536, Baltimore, Maryland, United States, 21287, Boston, Massachusetts, United States, 02111, Lahey Hospital and Medical Center - Burlington, Burlington, Massachusetts, United States, 08013, Michigan State University Clinical Center, East Lansing, Michigan, United States, 48824, Grand Rapids, Michigan, United States, 49503, Wayne State University Group - Detroit Medical Center, Detroit Lakes, Minnesota, United States, 48201, Saint Louis, Missouri, United States, 63110, Wake Research - Clinical Research Center of Nevada, LLC, Stony Brook Neurosciences Institute-Neurology Associates, East Setauket, New York, United States, 11733, Great Neck, New York, United States, 11021, Chapel Hill, North Carolina, United States, 27599, Neuroscience Institute, Neurology, Atrium Health, Charlotte, North Carolina, United States, 28207, Durham, North Carolina, United States, 27710, University Hospitals Cleveland Medical Center, The Ohio State University - Wexner Medical Center, Springfield, Oregon, United States, 97499, Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States, 17033, Hospital of the University of Pennsylvania (HUP), Philadelphia, Pennsylvania, United States, 19104-4206, Philadelphia, Pennsylvania, United States, 19104, Charleston, South Carolina, United States, 29406, Charleston, South Carolina, United States, 29459, Nashville, Tennessee, United States, 37232, University of Texas Health Science Center - Houston - Clinical Research Unit, Burlington, Vermont, United States, 05405, Virginia Commonwealth University (VCU) Medical Center Neurology, Seattle, Washington, United States, 98122, West Virginia University Hospitals/West Virginia University Department of Neurology, Morgantown, West Virginia, United States, 26506, Ascension St Francis-Center for Neurological Disorders, Milwaukee, Wisconsin, United States, 53215, Canada, Ontario London Health Sciences Centre, University Health Network-Toronto General Hospital, Montreal Neurological Institute and Hospital, Ostrava, Moravian-Silesian, Czechia, 708 52, Depart. 2019 Feb 7;133(6):540-549 Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2020 Sep 15;11:572870. doi: 10.3389/fphar.2020.572870. Eculizumab (Soliris) may be considered medically necessary for an initial 26 week trial for the treatment of individuals 18 years of age or older with a diagnosis of myasthenia gravis … Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis). Ravulizumab has been developed using Xencor's antibody half-life prolongation technology (Xtendâ¢), which utilises antibody Fc variants to prolong half-life. Would you like email updates of new search results? (ravulizumab-cwvz) – A diagnosis of generalized Myasthenia Gravis (gMG) Positive serologic test for anti-acetylcholine antibodies Patient must be 18 years of age or older Myasthenia Gravis Foundation … History of thymectomy within the 12 months prior to screening. Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study. Aetna considers ravulizumab-cwvz (Ultomiris) medically neces… Smail SW, Saeed M, Twana Alkasalias, Khudhur ZO, Younus DA, Rajab MF, Abdulahad WH, Hussain HI, Niaz K, Safdar M. Food Chem Toxicol. [New Complement Therapeutics in Complement-Related Diseases]. Accessibility 2020. All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments. To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-QOL15r score, To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL total score, To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score. Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ] To assess the efficacy of ravulizumab compared with placebo in … Note: REQUIRES PRECERTIFICATION Precertification of ravulizumab-cwvz (Ultomiris) is required of all Aetna participating providers and members in applicable plan designs. ... Ravulizumab … There is a 4 week screening period to determine if the CHAMPION MG study is … Privacy, Help The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).