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

  
13 trials found
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1NCT04946669
(ClinicalTrials.gov)
February 1, 202117/5/2021An Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory DermatomyositisAn Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory DermatomyositisDermatomyositis;AbataceptDrug: AbataceptThe First Affiliated Hospital with Nanjing Medical UniversityNational Natural Science Foundation of ChinaRecruiting18 YearsN/AAll20Early Phase 1China
2ChiCTR2000036282
2020-12-012020-08-22A prospective, double-blind, positive control study of abatacept in the treatment of high-risk patients with dermatomyositis and rapidly progressing interstitial pneumoniaStudy on Early Diagnosis and Treatment Strategy of Dermatomyositis Complicated with Rapidly Progressive Interstitial Pneumonia dermatomyositisAbatacept 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 MedicineNULLPending1870BothAbatacept treatment group:20;Saline group:20;China
3EUCTR2016-002269-77-IT
(EUCTR)
04/12/201822/01/2021A 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 CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czechia;Korea, Democratic People's Republic of;Italy;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Sweden
4EUCTR2016-002269-77-FR
(EUCTR)
02/09/201711/02/2019A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of
5EUCTR2016-002269-77-DE
(EUCTR)
07/08/201728/04/2017A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of
6EUCTR2016-002269-77-SE
(EUCTR)
04/08/201724/05/2017A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Korea, Republic of;Sweden
7EUCTR2016-002269-77-CZ
(EUCTR)
20/07/201718/05/2017A 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of
8JPRN-JapicCTI-173670
04/5/201709/08/2017Trial 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 MyopathyA 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 18Intervention 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.complete18BOTH150Phase 3Japan, Asia except Japan, North America, South America, Europe, Oceania
9NCT02594735
(ClinicalTrials.gov)
November 201521/10/2015Abatacept in Juvenile DermatomyositisAbatacept for the Treatment of Refractory Juvenile DermatomyositisDermatomyositisDrug: AbataceptGeorge Washington UniversityNULLCompleted7 YearsN/AAll10Phase 4United States
10EUCTR2009-015957-20-GB
(EUCTR)
29/05/201220/04/2012A 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 HospitalNULLNot RecruitingFemale: yes
Male: yes
20United Kingdom;Sweden
11EUCTR2009-015957-20-CZ
(EUCTR)
27/01/201117/09/2010Abatacept treatment in polymyositis and dermatomyositis - ARTEMISAbatacept 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Czech Republic;United Kingdom;Sweden
12NCT01315938
(ClinicalTrials.gov)
January 201115/3/2011Abatacept Treatment in Polymyositis and DermatomyositisAbatacept Treatment in Polymyositis and DermatomyositisPolymyositis;DermatomyositisDrug: Abatacept Active Treatment;Drug: Abatacept Delayed-Onset TreatmentKarolinska InstitutetInstitute of Rheumatology, Prague;King's College Hospital NHS TrustCompleted18 Years80 YearsAll20Phase 2Czechia;Sweden;Czech Republic
13EUCTR2009-015957-20-SE
(EUCTR)
16/02/201007/01/2010Abatacept treatment in polymyositis and dermatomyositis - ARTEMISAbatacept 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20United Kingdom;Sweden