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 |
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1 | EUCTR2016-002902-37-NL (EUCTR) | 28/06/2018 | 24/01/2018 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Germany;Netherlands | ||
2 | NCT02728752 (ClinicalTrials.gov) | February 27, 2017 | 11/3/2016 | Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy) | Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (ProDERM Study) | Dermatomyositis | Drug: Octagam 10%;Other: Placebo | Octapharma | NULL | Completed | 18 Years | N/A | All | 95 | Phase 3 | United States;Canada;Czechia;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Ukraine;Czech Republic;France |
3 | EUCTR2016-002902-37-DE (EUCTR) | 21/02/2017 | 29/09/2016 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G Trade Name: Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung Product Name: 0.9% w/v isotonic sodium chloride solution INN or Proposed INN: SODIUM CHLORIDE | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany | ||
4 | EUCTR2016-002902-37-HU (EUCTR) | 09/02/2017 | 19/12/2016 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 19.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Germany | ||
5 | EUCTR2016-002902-37-CZ (EUCTR) | 20/12/2016 | 26/09/2016 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 3 | Canada;Czech Republic;Netherlands;Russian Federation;Romania;Hungary;United States;Ukraine;Poland;France;Germany |