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 | EUCTR2018-003171-35-HU (EUCTR) | 13/02/2023 | 14/12/2022 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | Argentina;Russian Federation;Hungary;United States;Japan;Ukraine;United Kingdom;Switzerland;Spain;Belgium;European Union;Mexico;Italy;Australia;France;Germany | ||
| 2 | EUCTR2018-003171-35-DE (EUCTR) | 20/01/2020 | 18/09/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan | ||
| 3 | EUCTR2018-003171-35-BE (EUCTR) | 21/11/2019 | 18/09/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan | ||
| 4 | EUCTR2018-003171-35-ES (EUCTR) | 14/11/2019 | 29/11/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan | ||
| 5 | NCT04044690 (ClinicalTrials.gov) | October 21, 2019 | 1/8/2019 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study | Dermatomyositis | Drug: human immunoglobulin G;Drug: Placebo | CSL Behring | NULL | Recruiting | 18 Years | N/A | All | 126 | Phase 3 | United States;Belgium;Czechia;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Australia |
| 6 | EUCTR2018-003171-35-IT (EUCTR) | 21/10/2019 | 22/01/2021 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) - NA | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: [IgPro20] INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL BEHRING GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Canada;Argentina;Australia;Germany;Japan | ||
| 7 | EUCTR2018-003171-35-FR (EUCTR) | 24/09/2019 | 11/09/2019 | A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM) | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland | ||
| 8 | NCT02271165 (ClinicalTrials.gov) | November 2014 | 15/10/2014 | Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study | Dermatomyositis | Drug: Immunoglobulin (Hizentra) | Thomas Jefferson University | NULL | Terminated | 18 Years | N/A | All | 2 | Early Phase 1 | United States |