50. 皮膚筋炎／多発性筋炎 Dermatomyositis Clinical trials / Disease details
臨床試験数 : 182 / 薬物数 : 229 - (DrugBank : 88) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 147
| 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 | NCT04946669 (ClinicalTrials.gov) | February 1, 2021 | 17/5/2021 | An Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory Dermatomyositis | An Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory Dermatomyositis | Dermatomyositis;Abatacept | Drug: Abatacept | The First Affiliated Hospital with Nanjing Medical University | National Natural Science Foundation of China | Recruiting | 18 Years | N/A | All | 20 | Early Phase 1 | China |
| 2 | ChiCTR2000036282 | 2020-12-01 | 2020-08-22 | A prospective, double-blind, positive control study of abatacept in the treatment of high-risk patients with dermatomyositis and rapidly progressing interstitial pneumonia | Study on Early Diagnosis and Treatment Strategy of Dermatomyositis Complicated with Rapidly Progressive Interstitial Pneumonia | dermatomyositis | Abatacept treatment group:The initial dose was 10 mg/kg per month, and the intravenous infusion treatment of the treatment group was started by OW for 3 months.;Saline group:Using a light-shielding simulation bag that was completely consistent with the appearance and measurement of Abatacept, intravenous infusion was started for the placebo group at 0W. The infusion conditions were exactly the same as those in the treatment group and lasted for 3 months.; | Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine | NULL | Pending | 18 | 70 | Both | Abatacept treatment group:20;Saline group:20; | China | |
| 3 | 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 | Authorised-recruitment may be ongoing or finished | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | JPRN-JapicCTI-173670 | 04/5/2017 | 09/08/2017 | Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy | 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) | Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18 | Intervention name : Abatacept INN of the intervention : Abatacept Dosage And administration of the intervention : Abatacept subcutaneous + Standard Treatment Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo of Abatacept subcutaneous + Standard Treatment | Bristol-Myers Squibb K.K. | Ono Pharmaceutical Co., Ltd. | complete | 18 | BOTH | 150 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | |
| 9 | NCT02971683 (ClinicalTrials.gov) | March 13, 2017 | 21/11/2016 | Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy | 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) | Polymyositis;Dermatomyositis;Autoimmune Necrotizing Myopathy;Overlap Myositis;Juvenile Myositis Above the Age of 18 | Drug: Abatacept subcutaneous;Drug: Placebo | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Sweden;Hungary |
| 10 | NCT02594735 (ClinicalTrials.gov) | November 2015 | 21/10/2015 | Abatacept in Juvenile Dermatomyositis | Abatacept for the Treatment of Refractory Juvenile Dermatomyositis | Dermatomyositis | Drug: Abatacept | George Washington University | NULL | Completed | 7 Years | N/A | All | 10 | Phase 4 | United States |
| 11 | 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 | |||
| 12 | 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 | ||
| 13 | NCT01315938 (ClinicalTrials.gov) | January 2011 | 15/3/2011 | Abatacept Treatment in Polymyositis and Dermatomyositis | Abatacept Treatment in Polymyositis and Dermatomyositis | Polymyositis;Dermatomyositis | Drug: Abatacept Active Treatment;Drug: Abatacept Delayed-Onset Treatment | Karolinska Institutet | Institute of Rheumatology, Prague;King's College Hospital NHS Trust | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | Czechia;Sweden;Czech Republic |
| 14 | 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 |