50. 皮膚筋炎／多発性筋炎 Dermatomyositis Clinical trials / Disease details
臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-002710-31-DE (EUCTR) | 20/08/2018 | 24/05/2018 | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | Dermatomyositis MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Octanorm 16.5% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Octapharma Pharmazeutika Produktionsges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Romania;Russian Federation;Netherlands;Germany | ||
| 2 | EUCTR2017-002710-31-RO (EUCTR) | 16/07/2018 | 25/05/2022 | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | Dermatomyositis MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Octanorm 16.5% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Octapharma Pharmazeutika Produktionsges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Hungary;Czech Republic;Canada;Romania;Russian Federation;Germany | ||
| 3 | EUCTR2017-002710-31-HU (EUCTR) | 10/07/2018 | 19/07/2018 | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | Dermatomyositis MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Octanorm 16.5% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Octapharma Pharmazeutika Produktionsges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Czech Republic;Hungary;Canada;Russian Federation;Germany | ||
| 4 | EUCTR2017-002710-31-CZ (EUCTR) | 27/06/2018 | 01/06/2018 | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | Dermatomyositis MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Octanorm 16.5% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Octapharma Pharmazeutika Produktionsges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Hungary;Czech Republic;Canada;Russian Federation;Germany | ||
| 5 | EUCTR2005-002463-88-HU (EUCTR) | 11/03/2010 | 01/10/2009 | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy(Glucocorticosteroids associated with immunosuppresors) | Trade Name: Ig Vena Product Name: Ig VENA (10g/200mL) Product Code: L0133 | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria | |||
| 6 | EUCTR2005-002463-88-CZ (EUCTR) | 16/12/2009 | 05/10/2009 | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. | Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy (Glucocorticosteroids associated with immunosuppressors) | Trade Name: Ig Vena Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human normal immunoglogulin (IVIg) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Germany;Czech Republic;Italy;Austria | |||
| 7 | EUCTR2005-002463-88-IT (EUCTR) | 17/08/2006 | 21/04/2006 | fficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM) | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. | Idiopathic dermatomyositis and polymyositis with insufficiently improved muscle strength under conventional therapy (glucocorticosteroids associated with immunosuppressors). MedDRA version: 14.1;Level: HLT;Classification code 10003821;Term: Muscular autoimmune disorders;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: IGVENA*FL 200ML 10G+SET | ORFAGEN | NULL | Not Recruiting | Female: yes Male: yes | 44 | Czech Republic;Hungary;Austria;Germany;Italy | |||
| 8 | EUCTR2005-002463-88-DE (EUCTR) | 18/07/2006 | 28/12/2005 | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors). | Trade Name: Ig VENA Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human normal immunoglobulin (IVIg) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria | |||
| 9 | EUCTR2005-002463-88-AT (EUCTR) | 02/02/2006 | 17/01/2006 | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study | Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors). | Trade Name: Ig VENA Product Name: Ig VENA (10g/200mL) Product Code: L0133 Other descriptive name: Human normal immunoglobulin (IVIg) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria |