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  • 進捗状況
  • 試験名
  • 対象疾患名
  • 地域
  • 登録日
  •  

  • Authorised

  • A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
  • Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 14.1 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
  • Bulgaria, Colombia, Czech Republic, Hungary, India, Korea, Republic of, Lithuania, Mexico, Poland, Ukraine, United Kingdom
  • 2013-02-20

  • Authorised

  • Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types of Childhood Arthritis
  • OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS MedDRA version: 14.0 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
  • Australia, Belgium, Colombia, Czech Republic, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Slovenia, Spain
  • 2011-06-08

  • Authorised

  • Clinical study in which patients with bone cancer in the leg and who are undergoing surgery to remove the tumor and reconstruct the leg using a metal implant are randomly assigned to 1 of 2 antibiotic regimens.
  • * Patients with a primary bone malignancy or soft-tissue sarcoma that has invaded a lower extremity bone that are undergoing surgical treatment to resect the tumor and functionally reconstruct the limb using a modular metallic and polyethylene endoprosthetic implant to replace the surgically resected bones and joints. * Development of a surgical site infection according to the guidelines established by the Centers for Disease Control and Prevention (CDC) MedDRA version: 20.0 Level: PT Classification code 10064736 Term: Antibiotic prophylaxis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.1 Level: LLT Classification code 10056641 Term: Post procedural site wound infection System Organ Class: 100000004862 MedDRA version: 20.1 Level: PT Classification code 10068943 Term: Limb reconstructive surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10036894 Term: Prophylactic antibiotic therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10005978 Term: Bone lesion excision System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10073235 Term: Bone prosthesis insertion System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: PT Classification code 10006007 Term: Bone sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
  • Argentina, Australia, Austria, Brazil, Canada, South Africa, Spain, United States
  • 2017-09-07

  • Authorised

  • Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA)
  • Ulcerative colitis or Crohn's Disease MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
  • Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Ukraine, United Kingdom, United States
  • 2017-09-04

  • Authorised

  • EFFICACY AND SAFETY OF LACOSAMIDE AS ADJUNCTIVE THERAPY IN SUBJECTS =1 MONTH TO <4 YEARS WITH PARTIAL-ONSET SEIZURES
  • Epilepsy with partial onset seizures MedDRA version: 18.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
  • Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Korea, Republic of, Lithuania, Mexico, Moldova, Republic of, Poland, Romania, Serbia, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
  • 2015-03-10