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

  
18 trials found
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PhaseCountries
1EUCTR2018-003171-35-HU
(EUCTR)
13/02/202314/12/2022A 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3Argentina;Russian Federation;Hungary;United States;Japan;Ukraine;United Kingdom;Switzerland;Spain;Belgium;European Union;Mexico;Italy;Australia;France;Germany
2EUCTR2018-003171-35-DE
(EUCTR)
20/01/202018/09/2019A 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan
3EUCTR2018-003171-35-BE
(EUCTR)
21/11/201918/09/2019A 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 LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan
4EUCTR2018-003171-35-ES
(EUCTR)
14/11/201929/11/2019A 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 LLCNULLAuthorised-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): noUnited States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan
5EUCTR2018-003171-35-IT
(EUCTR)
21/10/201922/01/2021A 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 GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
126Phase 3United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Canada;Argentina;Australia;Germany;Japan
6NCT04044690
(ClinicalTrials.gov)
October 21, 20191/8/2019A 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 StudyDermatomyositisDrug: human immunoglobulin G;Drug: PlaceboCSL BehringNULLRecruiting18 YearsN/AAll126Phase 3United States;Belgium;Czechia;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Australia
7EUCTR2018-003171-35-FR
(EUCTR)
24/09/201911/09/2019A 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 LLCNULLAuthorised-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): noUnited States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland
8EUCTR2017-002710-31-DE
(EUCTR)
20/08/201824/05/2018DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS.DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. Dermatomyositis
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Octanorm 16.5%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Octapharma Pharmazeutika Produktionsges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
78Phase 3United States;Hungary;Czech Republic;Canada;Poland;Romania;Russian Federation;Netherlands;Germany
9EUCTR2017-002710-31-RO
(EUCTR)
16/07/201825/05/2022DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS.DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. Dermatomyositis
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Octanorm 16.5%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Octapharma Pharmazeutika Produktionsges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
78Phase 3United States;Hungary;Czech Republic;Canada;Romania;Russian Federation;Germany
10EUCTR2017-002710-31-HU
(EUCTR)
10/07/201819/07/2018DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS.DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. Dermatomyositis
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Octanorm 16.5%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Octapharma Pharmazeutika Produktionsges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
78Phase 3United States;Czech Republic;Hungary;Canada;Russian Federation;Germany
11EUCTR2017-002710-31-CZ
(EUCTR)
27/06/201801/06/2018DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS.DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. Dermatomyositis
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Octanorm 16.5%
INN or Proposed INN: Human Normal Immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Octapharma Pharmazeutika Produktionsges.m.b.HNULLNot RecruitingFemale: yes
Male: yes
78Phase 3United States;Hungary;Czech Republic;Canada;Russian Federation;Germany
12JPRN-UMIN000032193
2018/04/1113/04/2018Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trialEfficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial - Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung diseasePatients without poor prognostic factors:
combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months

Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of prednisolone is 60mg/body/day). Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity.
After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more in the study period (12 months).

Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml.

For patients with poor prognostic factors, attending physician can chose any treatments (e.g. corticosteroid, immunosuppressant, IVIG). The patients were followed up for 12 months.
Second Division, Department of Internal Medicine, Hamamatsu University School of MedicineNULLRecruiting20years-old80years-oldMale and Female40Not selectedJapan
13EUCTR2005-002463-88-HU
(EUCTR)
11/03/201001/10/2009Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled studyEfficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy(Glucocorticosteroids associated with immunosuppresors)Trade Name: Ig Vena
Product Name: Ig VENA (10g/200mL)
Product Code: L0133
OrfagenNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Czech Republic;Germany;Italy;Austria
14EUCTR2005-002463-88-CZ
(EUCTR)
16/12/200905/10/2009Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study.Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. Idiopathic DM and PM with insufficiently improved muscle strenght under conventional therapy (Glucocorticosteroids associated with immunosuppressors)Trade Name: Ig Vena
Product Name: Ig VENA (10g/200mL)
Product Code: L0133
Other descriptive name: Human normal immunoglogulin (IVIg)
OrfagenNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Germany;Czech Republic;Italy;Austria
15EUCTR2005-002463-88-IT
(EUCTR)
17/08/200621/04/2006fficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM)Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. Idiopathic dermatomyositis and polymyositis with insufficiently improved muscle strength under conventional therapy (glucocorticosteroids associated with immunosuppressors).
MedDRA version: 14.1;Level: HLT;Classification code 10003821;Term: Muscular autoimmune disorders;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: IGVENA*FL 200ML 10G+SETORFAGENNULLNot RecruitingFemale: yes
Male: yes
44Czech Republic;Hungary;Austria;Germany;Italy
16EUCTR2005-002463-88-DE
(EUCTR)
18/07/200628/12/2005Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled studyEfficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors).Trade Name: Ig VENA
Product Name: Ig VENA (10g/200mL)
Product Code: L0133
Other descriptive name: Human normal immunoglobulin (IVIg)
OrfagenNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Czech Republic;Germany;Italy;Austria
17EUCTR2005-002463-88-AT
(EUCTR)
02/02/200617/01/2006Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled studyEfficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study Idiopathic DM and PM with insufficiently improved muscle strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors).Trade Name: Ig VENA
Product Name: Ig VENA (10g/200mL)
Product Code: L0133
Other descriptive name: Human normal immunoglobulin (IVIg)
OrfagenNULLNot RecruitingFemale: yes
Male: yes
44Hungary;Czech Republic;Germany;Italy;Austria
18NCT00001261
(ClinicalTrials.gov)
May 19903/11/1999Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory MyopathiesThe Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-OverDermatomyositis;Inclusion Body Myositis;PolymyositisDrug: Gamma GlobulinNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth120Phase 2United States