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 | EUCTR2016-002269-77-IT (EUCTR) | 04/12/2018 | 22/01/2021 | A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle. | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) - A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatmen | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 21.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia Product Name: Orencia Product Code: [NA] INN or Proposed INN: ABATACEPT Other descriptive name: ABATACEPT | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Korea, Democratic People's Republic of;Italy;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Sweden | ||
| 2 | EUCTR2016-002269-77-FR (EUCTR) | 02/09/2017 | 11/02/2019 | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of | ||
| 3 | EUCTR2016-002269-77-DE (EUCTR) | 07/08/2017 | 28/04/2017 | A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle. | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of | ||
| 4 | EUCTR2016-002269-77-SE (EUCTR) | 04/08/2017 | 24/05/2017 | A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle. | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Korea, Republic of;Sweden | ||
| 5 | EUCTR2016-002269-77-CZ (EUCTR) | 20/07/2017 | 18/05/2017 | A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle. | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000018885;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of | ||
| 6 | EUCTR2009-015957-20-GB (EUCTR) | 29/05/2012 | 20/04/2012 | A clinical trial to investigate treatment with the drug abatacept in patients with polymyositis and dermatomyositis. | Abatacept Treatment in Polymyositis and Dermatomyositis - Artemis UK | Polymyositis and dermatomyositis MedDRA version: 14.1;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Orencia Product Name: Orencia Product Code: EMEA/H/C/000701 INN or Proposed INN: Abatacept Other descriptive name: Orencia (trade name) | Karolinska University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | United Kingdom;Sweden | |||
| 7 | EUCTR2009-015957-20-CZ (EUCTR) | 27/01/2011 | 17/09/2010 | Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS | Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS | polymyositis and dermatomyositis MedDRA version: 12.1;Level: LLT;Classification code 10036102;Term: Polymyositis MedDRA version: 12.1;Classification code 10012503;Term: Dermatomyositis | Trade Name: ORENCIA INN or Proposed INN: ABATACEPT | Karolinska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Czech Republic;United Kingdom;Sweden | ||
| 8 | EUCTR2009-015957-20-SE (EUCTR) | 16/02/2010 | 07/01/2010 | Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS | Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS | polymyositis and dermatomyositis MedDRA version: 12.1;Level: LLT;Classification code 10036102;Term: Polymyositis MedDRA version: 12.1;Classification code 10012503;Term: Dermatomyositis | Trade Name: ORENCIA INN or Proposed INN: ABATACEPT | Karolinska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | United Kingdom;Sweden |