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 50. 皮膚筋炎/多発性筋炎 [臨床試験数:84,薬物数:124(DrugBank:38),標的遺伝子数:47,標的パスウェイ数:139] 

Searched query = "Dermatomyositis", "Polymyositis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
Inclusion_
agemin
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PhaseCountries
1NCT04033926December 201911 November 2019A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or DermatomyositisA Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients With Active Polymyositis or DermatomyositisPolymyositis;DermatomyositisDrug: KZR-616;Drug: PlaceboKezar Life Sciences, Inc.Recruiting18 YearsN/AAll24Phase 2United States
2NCT04044690October 21, 201911 November 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)DermatomyositisDrug: human immunoglobulin G;Drug: PlaceboCSL BehringRecruiting18 YearsN/AAll126Phase 3United States;Japan
3NCT02418273August 1, 201916 December 2017Denosumab for Glucocorticoid-treated Children With Rheumatic DisordersDenosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot StudyOsteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced OsteoporosisDrug: denosumabIndiana UniversityNot recruiting4 Years16 YearsAll24Phase 1/Phase 2United States
4NCT03981744July 26, 201911 November 2019A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care TreatmentsA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care TreatmentsPolymyositis;DermatomyositisDrug: Ustekinumab 6 mg/kg;Drug: Ustekinumab 90 mg;Drug: Placebo IV;Drug: Placebo SCJanssen Pharmaceutical K.K.Recruiting18 Years75 YearsAll50Phase 3Japan
5EUCTR2018-003273-10-HU05/04/201930 April 2019A study of safety and efficacy of lenabasum in dermatomyositis patientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis - A Phase 3 safety and efficacy study of lenabasum in dermatomyositis subjectsDermatomyositis (DM)
MedDRA version: 20.0 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: Lenabasum
Product Code: JBT-101
Pharmaceutical Form: Capsule
INN or Proposed INN: Lenabasum
CAS Number: 137945-48-3
Current Sponsor code: JBT-101
Other descriptive name: resunab, ajulemic acid, anabasum
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Corbus Pharmaceuticals, Inc.Authorised Female: yes
Male: yes
150Phase 3Serbia;United States;Spain;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03816345April 4, 201911 November 2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)Recruiting18 YearsN/AAll264Phase 1United States
7NCT03813160December 17, 201830 September 2019Trial to Evaluate Efficacy and Safety of Lenabasum in DermatomyositisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in DermatomyositisDermatomyositisDrug: Lenabasum 20 mg;Drug: Lenabasum 5 mg;Drug: PlaceboCorbus Pharmaceuticals Inc.Recruiting18 YearsN/AAll150Phase 3United States;Hungary
8NCT03817424December 13, 201830 September 2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioRecruiting18 Years75 YearsAll32Phase 1United States;Poland;Spain
9EUCTR2017-002710-31-DE20/08/201826 November 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%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Human Normal Immunoglobulin
CAS Number: 308067-58-5
Current Sponsor code: Octanorm 16.5%
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: % percent
Concentration type: equal
Concentration number: 16.5-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Octapharma Pharmazeutika Produktionsges.m.b.HNot RecruitingFemale: yes
Male: yes
78Phase 3United States;Hungary;Czech Republic;Canada;Poland;Romania;Russian Federation;Netherlands;Germany
10NCT03686969August 2, 20184 March 2019Study Evaluating Efficacy and Safety of Octanorm in Patients With DermatomyositisDouble-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Dermatomyositis (SCGAM-02)DermatomyositisDrug: Octanorm;Other: PlaceboOctapharmaNot recruiting18 Years80 YearsAll1Phase 3Russian Federation;Czechia;Germany;Hungary;Poland;Romania
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03529955June 12, 201829 April 2019Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant DermatomyositisA Phase 2, Open Label Single Arm Study for Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant DermatomyositisDermatomyositis, Adult TypeDrug: Apremilast 30mgTulane UniversityRecruiting18 Years75 YearsAll10Phase 2United States
12NCT03857854June 5, 201811 March 2019Efficacy and Safety of Pirfenidone in Patient With Dermatomyositis Interstitial Lung Disease (Dm-ILD)A Phase III, Randomized, Double-blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Pirfenidone in Subjects With Dermatomyositis Interstitial Lung Disease (Dm-ILD)Dermatomyositis Interstitial Lung Disease (Dm-ILD)Drug: Pirfenidone;Drug: PlacebosBeijing Continent Pharmaceutical Co, Ltd.Recruiting18 Years65 YearsAll152Phase 3China
13JPRN-UMIN0000321932018/04/1116 July 2019Efficacy 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-ILDanti-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 MedicineRecruiting20years-old80years-oldMale and Female40Not selectedJapan
14JPRN-UMIN0000320222018/04/0116 July 2019Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trialEfficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial - Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILDanti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung diseaseArm 1: corticosteroid (prednisolone) monotherapy for 24 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 (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month).
Arm 2: combination therapy of corticosteroid (prednisolone) and tacrolimus for 24 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 (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month).

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.
Hamamatsu University School of MedicineRecruiting20years-old80years-oldMale and Female66Not selectedJapan
15NCT03430388January 31, 20186 May 2019Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNot recruiting2 Years60 YearsAll600N/ABrazil
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03181893January 23, 201822 July 2019A Study In Adults With Moderate To Severe DermatomyositisA PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITISDermatomyositisDrug: PF-06823859;Drug: Placebo ArmPfizerRecruiting18 Years80 YearsAll30Phase 2United States
17NCT03267277October 5, 20174 November 2019Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult DermatomyositisAn Open-label Study of Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult DermatomyositisJuvenile Dermatomyositis;Dermatomyositis;Idiopathic Inflammatory MyopathiesDrug: Sodium ThiosulfateNational Institute of Environmental Health Sciences (NIEHS)Recruiting7 Years99 YearsAll250Phase 2United States
18ChiCTR18000166292017-07-0118 June 2018An observation of tofacitinib in patients of MDA5+ clinically amyopathic dermatomyositis with interstitial lung diseaseAn observation of tofacitinib in patients of MDA5+ clinically amyopathic dermatomyositis with interstitial lung diseasedermatomyositisstudy group:tofacitinib;control group:glucocorticoids+immunosuppressant;Ren Ji Hospital South Campus, Shanghai Jiaotong University School of MedicineRecruiting1880Bothstudy group:15;control group:35;Post-marketChina
19NCT03192657July 201716 December 2017Basiliximab Treating Interstitial Pneumonia of CADMBasiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis PatientsLung; Disease, Interstitial, With Fibrosis;DermatomyositisDrug: Basiliximab;Drug: Calcineurin Inhibitors;Drug: SteroidsRenJi HospitalNot recruiting18 Years65 YearsAll100Phase 2China
20NCT02980198May 3, 20177 October 2019Study of IFN-K in DermatomyositisA Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNa-Kinoid (IFN-K) in Adult Subjects With DermatomyositisDermatomyositisBiological: IFN-Kinoid;Other: Placebo;Other: ISA 51NeovacsNot recruiting18 Years65 YearsAll30Phase 2France;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-003277-15-SE12/04/201720 August 2018A Phase 2 Study of IMO-8400 in Patients with DermatomyositisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with DermatomyositisDermatomyositis
MedDRA version: 19.1 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IMO-8400
Product Code: IMO-8400
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: IMO-8400
Current Sponsor code: IMO-8400
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: IMO-8400
Product Code: IMO-8400
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: IMO-8400
Current Sponsor code: IMO-8400
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Idera Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
36Phase 2United States;Hungary;Czech Republic;United Kingdom;Sweden
22NCT02971683March 13, 201726 August 2019Trial 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 18Drug: Abatacept subcutaneous;Drug: PlaceboBristol-Myers SquibbRecruiting18 YearsN/AAll150Phase 3United States;Australia;Brazil;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Sweden
23JPRN-JapicCTI-17367001/3/201716 July 2019Trial 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
Dosage And administration of the control intervention : Placebo of Abatacept subcutaneous + Standard Treatment
Bristol-Myers Squibb K.K.Recruiting18BOTH150Phase 3
24NCT02728752February 27, 201715 July 2019Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (ProDERM Study)DermatomyositisDrug: Octagam 10%;Other: PlaceboOctapharmaNot recruiting18 YearsN/AAll94Phase 3United States;Canada;Czechia;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine;Czech Republic;France;Romania
25NCT03002649January 201730 September 2019Study of Tofacitinib in Refractory DermatomyositisStudy of Tofacitinib in Refractory Dermatomyositis (STIR): Proof of Concept, Open-Label Study of 10 PatientsDermatomyositisDrug: TofacitinibJohns Hopkins UniversityPfizerNot recruiting18 YearsN/AAll10Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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size
PhaseCountries
26NCT03092154January 20173 December 2018Lipid-lowering Agents in Patients With Dermatomyositis and PolymyositisLipid-lowering Agents in Patients With Dermatomyositis and PolymyositisTreatment Side EffectsDrug: Lipid-lowering agents (Artovastatin)University of Sao PauloRecruiting18 YearsN/AAll40N/ABrazil
27EUCTR2016-002902-37-CZ20/12/201628 February 2019CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study)PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study)Dermatomyositis
MedDRA version: 20.0 Level: LLT Classification code 10001403 Term: Adult dermatomyositis System Organ Class: 100000004858 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Octagam 10%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: IMMUNOGLOBULIN G
CAS Number: 308067-58-5
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous drip use (Noncurrent)
Octapharma Pharmazeutika Produktionsges.m.b.H.AuthorisedFemale: yes
Male: yes
94Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany
28EUCTR2015-003277-15-GB02/09/201628 February 2019A Phase 2 Study of IMO-8400 in Patients with DermatomyositisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with DermatomyositisDermatomyositis
MedDRA version: 19.1 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IMO-8400
Product Code: IMO-8400
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: IMO-8400
Current Sponsor code: IMO-8400
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Product Name: IMO-8400
Product Code: IMO-8400
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: IMO-8400
Current Sponsor code: IMO-8400
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Idera Pharmaceuticals, Inc.Not Recruiting Female: yes
Male: yes
36Phase 2United States;Hungary;Czech Republic;United Kingdom;Sweden
29NCT02780674August 26, 201612 February 2018A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune DiseasesA Phase 1, Randomized, Blinded, Single-Dose, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune DiseasesDermatomyositis, Polymyositis, Sjogren's, SLE, SScBiological: MEDI7734;Biological: PlaceboMedImmune LLCNot recruiting18 Years65 YearsAll36Phase 1United States
30EUCTR2015-003277-15-HU12/08/201621 May 2018A Phase 2 Study of IMO-8400 in Patients with DermatomyositisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with DermatomyositisDermatomyositis
MedDRA version: 19.0 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: IMO-8400
Product Code: IMO-8400
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: IMO-8400
Current Sponsor code: IMO-8400
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Idera Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
36Phase 2United States;Czech Republic;Hungary;United Kingdom;Sweden
No.TrialIDDate_
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Last_Refreshed_
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31NCT03027674August 201616 December 2017Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary RaynaudColor Doppler Ultrasound Comparison of Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud: A Randomized, Double-blind, Placebo-controlled Pilot StudyRaynaud Phenomenon Due to Trauma;Raynaud Disease;System; Sclerosis;Lupus Erythematosus, Systemic;Dermatomyositis;Ultrasound Therapy; ComplicationsDrug: 10% nifedipine cream;Drug: 5% sildenafil creamPontificia Universidad Catolica de ChileNot recruiting13 Years99 YearsAll10Early Phase 1Chile
32EUCTR2016-000137-52-DE26/07/20168 January 2018Phase IIa exploratory study to assess the safety and effect of IFNa-Kinoid (IFN-K) in adult patients with DermatomyositisA Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNa-Kinoid (IFN-K) in Adult Subjects with Dermatomyositis.Dermatomyositis
MedDRA version: 19.1 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: IFNa-Kinoid
Product Code: IFN-K
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Not yet assigned
Current Sponsor code: IFN-K DS
Other descriptive name: IFN-Kinoid Drug Substance
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 380-
Pharmaceutical form of the placebo: Emulsion for injection
Route of administration of the placebo: Intramuscular use
Neovacs SANot RecruitingFemale: yes
Male: yes
30Phase 2France;Germany;Italy;United Kingdom;Switzerland
33NCT02821689July 201611 July 2016Pirfenidone in Progressive Interstitial Lung Disease Associated With Clinically Amyopathic DermatomyositisRandomized Controlled Trial of Pirfenidone in Patients With Progressive Interstitial Lung Disease Associated With Clinically Amyopathic DermatomyositisDermatopolymyositis;Interstitial Lung DiseaseDrug: PirfenidoneRenJi HospitalNot recruiting16 YearsN/ABoth57Phase 4China
34NCT02594735November 20154 February 2019Abatacept in Juvenile DermatomyositisAbatacept for the Treatment of Refractory Juvenile DermatomyositisDermatomyositisDrug: AbataceptGeorge Washington UniversityRecruiting7 YearsN/AAll10Phase 4United States
35NCT02612857November 201522 October 2019Trial of IMO-8400 in Adult Patients With DermatomyositisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With DermatomyositisDermatomyositisDrug: IMO-8400 Dose Group 1;Drug: IMO-8400 Dose Group 2;Drug: PlaceboIdera Pharmaceuticals, Inc.Not recruiting18 Years75 YearsAll30Phase 2United States;Hungary;United Kingdom
No.TrialIDDate_
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PhaseCountries
36JPRN-UMIN0000183762015/07/2223 April 2019Efficacy and safety of rituximab for patients with severe rheumatic diseaseEfficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic diseaseChildhood-onset severe rheumatic disease (systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)1) Induction Therapy
rituximab 375mg/m2 (max500mg)
1-4 times/1-2 weeks

2) Maintenance Therapy
rituximab 375mg/m2 (max500mg)
1 times/6-12 months
Yokohama City University Hospital Department of PediatricsNot Recruiting2years-oldNot applicableMale and Female20Not selectedJapan
37NCT02245841June 201523 April 2019Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of DermatomyositisEfficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of DermatomyositisDermatomyositis;Juvenile DermatomyositisDrug: H.P. Acthar GelThe Cleveland ClinicMallinckrodtRecruiting18 YearsN/AAll15Phase 4United States
38NCT02466243June 201525 February 2019Safety, Tolerability, and Efficacy of JBT-101 in Subjects With DermatomyositisA Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With DermatomyositisDermatomyositisDrug: JBT-101;Drug: PlaceboCorbus Pharmaceuticals Inc.National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of PennsylvaniaNot recruiting18 Years70 YearsAll22Phase 2United States
39NCT02267005March 201511 June 2018The Effect of Creatine Supplementation on Muscle Function in Childhood MyositisThe Effect of Creatine Supplementation on Muscle Function in Childhood MyositisJuvenile DermatomyositisDietary Supplement: Creapure;Dietary Supplement: Glucose TabletThe Hospital for Sick ChildrenNot recruiting7 Years18 YearsAll13N/ACanada
40EUCTR2015-003424-31-GB28 February 2019Treatment of autoinflammatory diseasesTreatment of Conditions Expected to Benefit from JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis - JAGACANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis, Aicardi-Goutieres Syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Baricitinib
Product Code: LY3009104
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Baricitinib
Current Sponsor code: LY3009104
Other descriptive name: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: Baricitinib
Current Sponsor code: LY3009104
Other descriptive name: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
INN or Proposed INN: baricitinib
Current Sponsor code: LY3009104
Other descriptive name: BARICITINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Eli Lilly and CompanyNot Available Female: yes
Male: yes
60Phase 2France;United States;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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41NCT02271165November 201411 June 2018Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept StudyDermatomyositisDrug: Immunoglobulin (Hizentra)Thomas Jefferson UniversityNot recruiting18 YearsN/AAll2Early Phase 1United States
42JPRN-UMIN0000154692014/10/2010 September 2019Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung diseaseComparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILDpolymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung diseasearm1: tacrolimus and predonisolon therapy for 52 weeks

Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more.

Taclorimus 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.
arm2: cyclosporine and predonisolone therapy for 52 weeks

Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more.

Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml.
Second Division, Department of Internal medicine, Hamamatsu University School of MedicineNot Recruiting18years-old75years-oldMale and Female50Not selectedJapan
43NCT02043548October 1, 201430 September 2019Tocilizumab in the Treatment of Refractory Polymyositis and DermatomyositisTocilizumab in the Treatment of Refractory Polymyositis and DermatomyositisDermatomyositis;PolymyositisDrug: tocilizumab;Drug: placeboChester OddisGenentech, Inc.Not recruiting18 YearsN/AAll36Phase 2United States
44ChiCTR-IPR-160079582014-06-0118 April 2017An observation of Pirfenidone in patients with rapidly progressive interstitial lung disease secondary to clinically amyopathic dermatomyositisAn observation of Pirfenidone in patients with rapidly progressive interstitial lung disease secondary to clinically amyopathic dermatomyositisclinically amyopathic dermatomyositisRsearch group: glucocorticoids+immunosuppressant+pirfenidone;Control group: glucocorticoids+immunosuppressant;Renji Hospital, Shanghai Jiaotong University School of MedicineNot RecruitingBothRsearch group:30;Control group:30;Post-marketChina
45JPRN-UMIN0000135462014/06/012 April 2019The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimusrheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitistake a glass of grapefruit juice every day
do not take grapefruit juice
Department of Rheumatology and Clinical Immunology, Kyoto University HospitalNot Recruiting16years-old80years-oldMale and Female20Not applicableJapan
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
46NCT02159651April 1, 201430 September 2019A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial PneumoniaSpecified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/DermatomyositisInterstitial Pneumonia Associated With Polymyositis/DermatomyositisDrug: tacrolimusAstellas Pharma IncNot recruitingN/AN/AAll179Phase 2/Phase 3Japan
47EUCTR2013-001799-39-HU26/09/201311 April 2016Study of efficacy and tolerability for BAF312 compared to placebo in patients with active dermatomyositis.A double blind, randomized, placebo-controlled study to evaluate, safety, tolerability, efficacy and preliminary dose-response of BAF312 in patients with active dermatomyositis. - safety and efficacy of BAF312 in dermatomyositisActive dermatomyositis
MedDRA version: 18.0 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Code: BAF312 0.25 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: BAF312 0.50 mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: BAF312 1mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Code: BAF312 2mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
56United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Belgium;Netherlands;Germany;Japan;China;Switzerland
48EUCTR2012-005772-34-SE04/09/201311 April 2016A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy disease.A randomised, double-blind, placebo-controlled proof-of concept study of the efficacy of gevokizumab 60mg subcutaneously every 4 weeks over 24 weeks in the treatment of patients with polymyositis, dermatomyositis or necrotizing autoimmune myopathy diseasePolymyositis / Dermatomyositis / necrotizing autoimmune myopathy
MedDRA version: 17.1 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1 Level: PT Classification code 10036102 Term: Polymyositis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Gevokizumab
Product Code: S78989
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gevokizumab
CAS Number: 1129435-60-4
Current Sponsor code: S78989
Other descriptive name: XOMA 052
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Institut de Recherches Internationales Servier (IRIS)Not RecruitingFemale: yes
Male: yes
40Greece;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden
49NCT01906372September 201316 December 2017Acthar in Treatment of Refractory Dermatomyositis and PolymyositisOpen Label Proof of Concept Study to Evaluate Efficacy and Safety of Adrenocorticotropic Hormone Gel in Refractory Dermatomyositis or PolymyositisDermatomyositis;PolymyositisDrug: Adrenocorticotropic Hormone GelRohit Aggarwal, MDMallinckrodtNot recruiting18 YearsN/AAll12Phase 2United States
50ChiCTR-TRC-130031782013-05-0118 April 2017Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical studyStudy of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical studyPolymyositis/Dermatomyositisgroup1-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg / d, then reduce 2.5mg every two weeks to 5mg/d, maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group1-predinsone+MTX group:MTX 10-20mgQw×24w; MTX 7.5-10mgQw×48w, the usage of prednisone is the same as in the control group.;group1-predinsone+LEF group:LEF 20mg/d×24w; LEF 10mg/d×48w, the usage of prednisone is the same as in the control group.;group2-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg/d, then reduce 2.5mg every two weeks to 5mg/d,maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group2-predinsone+CTX group:CTX iv 0.8-1.0g/4w×24w; CTX iv 0.8-1.0g/12w×48w, the usage of prednisone is the same as in the control group.;group2-predinsone+MTX group:MMF 1.5-2.0g /d×24w; MMF 0.75-1g/d×48w, the usage of prednisone is the same as in the control group.;Department of rheumatology, China-Japan Friendship hospitalRecruiting1870Bothgroup1-predinsone group(control group):94;group1-predinsone+MTX group:94;group1-predinsone+LEF group:94;group2-predinsone group(control group):94;group2-predinsone+CTX group:94;group2-predinsone+MTX group:94;OtherChina
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
51NCT01801917April 24, 201318 January 2018Efficacy and Tolerability of BAF312 in Patients With PolymyositisA Multi-centre Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With PolymyositisPolymyositisDrug: Placebo;Drug: BAF312Novartis PharmaceuticalsNot recruiting18 Years75 YearsAll14Phase 2United States;Canada;Czechia;Hungary;Poland;Taiwan;Belgium;Czech Republic;Netherlands;Switzerland
52NCT01637064April 201317 November 2015Dermatomyositis and Polymyositis RegistryActhar Dermatomyositis and Polymyositis TreatmentDermatomyositis;PolymyositisDrug: ActharPhoenix Neurological Associates, LTDRecruiting18 Years85 YearsBoth100N/AUnited States
53EUCTR2012-002859-42-HU25/01/201321 November 2016Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositisA multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositisPolymyositis
MedDRA version: 14.1 Level: PT Classification code 10036102 Term: Polymyositis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BAF312 0.25 mg tablet
Product Code: BAF312X
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimid
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: BAF312 1 mg tablet
Product Code: BAF312X
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Siponimod
CAS Number: 1234627-85-0
Current Sponsor code: BAF312
Other descriptive name: BAF312 hemifumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Czech Republic;Hungary;Canada;Belgium;Poland
54NCT01724580October 25, 201217 September 2018Compassionate Use Protocol for the Treatment of Autoinflammatory SyndromesCompassionate Use Treatment Protocol I4V-MC-JAGA: Treatment of Conditions Expected to Benefit From JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI and Severe Juvenile DermatomyositisChronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature (CANDLE);Juvenile Dermatomyositis (JDM);Stimulator of Interferon Genes (STING)-Associated Vasculopathy With Onset During Infancy (SAVI);Aicardi-Goutières Syndrome (AGS)Drug: BaricitinibEli Lilly and CompanyNot recruiting6 MonthsN/AAllPhase 1United States;United Kingdom
55NCT01572844August 201216 December 2017Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated CalcinosisNovel Drug Delivery of Sodium Thiosulfate for Calcinosis Associated With Adult and Juvenile DermatomyositisCalcinosisDevice: Fractionated Carbon Dioxide (FCO2) Laser;Drug: Sodium thiosulfateAlison EhrlichNot recruiting18 Years65 YearsAll3Phase 2United States
No.TrialIDDate_
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PhaseCountries
56NCT01217320January 201119 February 2015Creatine Supplementation in Pediatric RheumatologyEfficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile DermatomyositisJuvenile Systemic Lupus Erythematosus;Juvenile DermatomyositisDietary Supplement: creatine;Dietary Supplement: placebo (dextrose)University of Sao PauloRecruiting6 Years18 YearsBoth40N/ABrazil
57JPRN-UMIN0000319312010/12/012 April 2019Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositisDermatomyositisCyclophosphamide 2g/m2, 2 days
Harvest of autologous hematopoietic stem cells
Cyclophosphamide 50mg/kg, 4 days
Transplantation of autologous hematopoietic stem cells
Kyushu UniversityNot Recruiting16years-old65years-oldMale and Female10Phase 2Japan
58NCT01813617September 201019 February 2015Outcome in Patients With Recent Onset Polymyositis and DermatomyositisOutcome of Muscle Function and Disease Activity in Patients With Recent Onset Polymyositis and Dermatomyositis - a 1-year Follow-up Register StudyPolymyositis;DermatomyositisDrug: Immunosuppressive AgentsKarolinska University HospitalNot recruiting18 YearsN/ABoth72N/ASweden
59NCT01151644April 201019 February 2015Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesSafety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesRheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DMBiological: Anti-pandemic H1N1 influenza vaccineUniversity of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloNot recruitingN/AN/ABoth5000Phase 4Brazil
60EUCTR2009-015957-20-SE16/02/201026 June 2012Abatacept treatment in polymyositis and dermatomyositis - ARTEMISAbatacept treatment in polymyositis and dermatomyositis - ARTEMISpolymyositis and dermatomyositis
MedDRA version: 12.1 Level: LLT Classification code 10036102 Term: Polymyositis
MedDRA version: 12.1 Level: LLT Classification code 10012503 Term: Dermatomyositis
Trade Name: ORENCIA
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
Karolinska University HospitalAuthorisedFemale: yes
Male: yes
20United Kingdom;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
61NCT01140503February 201019 October 2017A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With DermatomyositisAn Open Label Study Evaluating the Safety and Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With DermatomyositisDermatomyositisDrug: ApremilastStanford UniversityNot recruiting18 YearsN/AAll5N/AUnited States
62EUCTR2008-006311-21-GB28/07/20099 October 2012A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositis -Polymyositis and dermatomyositis
MedDRA version: 9.1 Level: LLT Classification code 10036102 Term: Polymyositis
MedDRA version: 9.1 Level: LLT Classification code 10012503 Term: Dermatomyositis
Product Name: BAF312 5 mg tablet
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.0-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: BAF312 4mg tablet
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: BAF312 1 mg tablet
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: BAF312 0.25 mg tablet
Product Code: BAF312
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BAF312
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
45Hungary;Czech Republic;United Kingdom;Sweden
63JPRN-UMIN0000018662009/04/015 November 2019Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositisContinuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis - Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositisDermatomyositis or polymyositis with interstitial pneumonia(1)The patients are initially treated with methylprednisolone (m-PSL) pulse (1000 mg daily for three days) followed by oral prednisolone (1mg/kg daily).
(2)Continuous intravenous CyA (2 mg/kg daily for initial dose) is started following m-PSL pulse therapy, and the dosage will be adjusted to a level of 200-300ng/ml.
Department of Neurology and Rheumatology, Shinshu University School of MedicineNot Recruiting16years-oldNot applicableMale and Female10Not selectedJapan
64EUCTR2008-001282-28-NL23/09/200819 March 2012Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseasesInfluenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseasesRheumatic autoimmune diseases including rheumatoid arthritis and poly or dermatomyositis.Trade Name: Influvac
Pharmaceutical Form:
INN or Proposed INN: Influvac
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 0,5-
Trade Name: Pneumovax 23
Pharmaceutical Form:
INN or Proposed INN: Pneumovax 23
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 0,5-
Trade Name: HBvaxpro
Pharmaceutical Form:
INN or Proposed INN: HBVAXPRO
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Radboud University Nijmegen Medical CentreAuthorisedFemale: yes
Male: yes
Netherlands
65NCT00651040May 200819 October 2017Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DMA Prospective, Randomised, Assessor-blind, Multicenter Study of Efficacy and Safety of Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With Polymyositis and Dermatomyositis.Polymyositis;DermatomyositisDrug: Prednisone;Drug: MethotrexateInstitute of Rheumatology, PragueKarolinska InstitutetNot recruiting18 Years80 YearsAll31Phase 3Czech Republic
No.TrialIDDate_
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PhaseCountries
66NCT00533091April 200819 February 2015A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or PolymyositisA Phase 1B, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Safety of Multiple-Dose, Intravenously Administered MEDI-545, A Fully Human Anti Interferon-Alpha Monoclonal Antibody, In Adult Patients With Dermatomyositis or PolymyositisDERMATOMYOSITIS OR POLYMYOSITISBiological: MEDI-545;Other: PlaceboMedImmune LLCNot recruiting18 YearsN/ABoth51Phase 1United States
67EUCTR2007-004410-13-CZ12/03/200819 March 2012A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUSA PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUSactive polymyositis, dermatomyositis
MedDRA version: 9.1 Level: LLT Classification code 10012503 Term: Dermatomyositis
MedDRA version: 9.1 Level: LLT Classification code 10036102 Term: Polymyositis
Trade Name: Methotrexat Lachema 2,5mg
Product Name: Methotrexat Lachema 2,5mg tbl.
Product Code: 44/154/85-C
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Current Sponsor code: 01
Other descriptive name: methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-
Trade Name: Prednison 5, 20 Léciva por. tablet nob.
Product Name: Prednison 5, 20 Léciva por. tablet nob.
Product Code: 56/104/75-C
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob
CAS Number: 53032
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: Methotrexat Lachema 5 inj. sol
Product Name: Methotrexate Lachema 5inj. sol
Product Code: 44/196/81-C
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Solu-medrol inj. PSO LQF 40mg
Product Name: Solu-medrol inj. PSO lqf 40mg
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: methylprednisoloni natrii succinas
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Institute od Rheumatology PragueAuthorisedFemale: yes
Male: yes
50Czech Republic;Sweden
68JPRN-JMA-IIA0001220/07/20075 November 2019Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant TacrolimusAn open-label clinical trial of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis, with comparison against corticosteroid-treated historical controlsInterstitial pneumonitis associated with polymyositis/dermatomyositisIntervention type:DRUG. Intervention1:Tacrolimus, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg..IMPPACT study central officeHokkaido University Hospital, Tsukuba University Hospital, Chiba University Hospital, The University of Tokyo Hospital, Tokyo Medical and Dental University Hospital, International Medical Center of Japan, Juntendo University Hospital, Keio University Hospital, Osaka Minami Medical Center, Tokushima University Hospital, Nagasaki University Hospital of Medicine and DentistryNot Recruiting>=16 YEARS<75 YEARSBOTH20Phase 2-3Japan
69NCT00504348July 200716 December 2017Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant TacrolimusAn Open-label Clinical Trial of the Combination Treatment of Tacrolimus and Corticosteroid in Polymyositis/Dermatomyositis Patients With Interstitial Pneumonitis, With Comparison Against Corticosteroid-treated Historical ControlsInterstitial Pneumonitis;Polymyositis;DermatomyositisDrug: TacrolimusTokyo Medical and Dental UniversityJapan Medical Association;Astellas Pharma IncNot recruiting16 Years74 YearsAll26Phase 2/Phase 3Japan
70EUCTR2006-000078-65-SE17/01/200719 March 2012Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositisRituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositisAdult polymyositis or adult dermatomyositis or juvenile dermatomyositis
MedDRA version: 8.1 Level: LLT Classification code 10036102 Term: Polymyositis
Trade Name: Mabthera
Product Name: Mabthera
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Karolinska University HospitalNot RecruitingFemale: yes
Male: yes
202United Kingdom;Czech Republic;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2005-003956-37-NL26/09/200614 August 2012Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexateFive year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexateJuvenile Dermatomyositis at onsetPharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration number: 5-
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Methylprednisolone
CAS Number: 2921-57-5
Concentration unit: mg milligram(s)
Concentration number: 8-
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Ciclosporin
CAS Number: 59865-59-5
Concentration unit: mg milligram(s)
Concentration number: 10-
Pharmaceutical Form: Oral solution
INN or Proposed INN: Ciclosporin
CAS Number: 59865-59-5
Concentration unit: mg milligram(s)
Concentration number: 100-
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ciclosporin
CAS Number: 59865-59-5
Concentration unit: mg milligram(s)
Concentration number: 50-
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration number: 5-
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration number: 5-
Istituto Giannina GasliniAuthorisedFemale: yes
Male: yes
160Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
72EUCTR2005-002463-88-DE18/07/200619 March 2012Efficacy 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 studyIdiopathic 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
Pharmaceutical Form: Solution for infusion
Current Sponsor code: L0133
Other descriptive name: Human normal immunoglobulin (IVIg)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
OrfagenNot RecruitingFemale: yes
Male: yes
44Hungary;Czech Republic;Germany;Italy;Austria
73NCT00335985June 200619 February 2015Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)A Randomized, Double-blind, Controlled Clinical Study of GB-0998 for the Steroid-resistant Polymyositis and DermatomyositisPolymyositis;DermatomyositisDrug: GB-0998;Drug: Placebo of GB-0998Japan Blood Products OrganizationNot recruiting16 Years75 YearsBoth26Phase 3Japan
74NCT00323960May 200619 February 2015Five-year Actively Controlled Clinical Trial in New Onset Juvenile DermatomyositisFive-year Single-blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis: Prednisone Versus Prednisone Plus Cyclosporine a Versus Prednisone Plus MethotrexateJuvenile DermatomyositisDrug: 3 MPDN pulse + PDN;Drug: 3 MPDN pulse + PDN + CSA;Drug: 3 MPDN pulse + PDN + MTXIstituto Giannina GasliniPediatric Rheumatology International Trials OrganizationRecruiting1 Year18 YearsBoth120Phase 3Italy
75NCT00106184March 200619 October 2017Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM)Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathy (IIM)Myositis;Dermatomyositis;Polymyositis;Juvenile DermatomyositisDrug: Rituximab;Drug: PlaceboUniversity of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Genentech, Inc.;BiogenNot recruiting5 YearsN/AAll200Phase 2United States;Canada;Czech Republic;Sweden;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00112385March 200619 October 2017A Pilot Study of Etanercept in DermatomyositisA Pilot Study of Etanercept in DermatomyositisDermatomyositisDrug: Etanercept;Drug: PlaceboBrigham and Women's HospitalAmgenNot recruiting18 Years65 YearsAll16Phase 1United States
77NCT01165008September 200319 February 2015Anakinra in MyositisAnakinra in Patients With Refractory Idiopathic Inflammatory MyopathiesPolymyositis;Dermatomyositis;Inclusion Body MyositisDrug: AnakinraKarolinska InstitutetNot recruiting18 Years80 YearsBothPhase 2/Phase 3Sweden
78NCT00035958August 200219 February 2015Understanding the Pathogenesis and Treatment of Childhood Onset DermatomyositisToward Improved Understanding of Pathogenesis and Treatment of Childhood Onset DermatomyositisDermatomyositisDrug: Prednisone;Drug: Methotrexate;Drug: EtanerceptChildren's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Immunex CorporationNot recruiting4 Years16 YearsBoth75Phase 2/Phase 3United States
79NCT00033891April 10, 200211 November 2019Infliximab (Remicade ) to Treat Dermatomyositis and PolymyositisA Randomized, Double-Blind, Placebo-Controlled Trial of Infliximab in Patients With Dermatomyositis and PolymyositisDermatomyositis;PolymyositisDrug: InfliximabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/AAll14Phase 2United States
80NCT00138983May 200019 February 2015Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.Rheumatoid Arthritis;Polymyalgia Rheumatica;Giant Cell Arteritis;Polymyositis;Wegener’s GranulomatosisDrug: Alendronate versus alfacalcidol (1-alpha OH vitamin D)UMC UtrechtDutch Health Care Insurance BoardNot recruiting18 Years90 YearsBoth200Phase 3Netherlands
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00005571April 200019 February 2015Safety and Effectiveness of h5G1.1-mAb for DermatomyositisA Randomized, Third-Party-Blind, Placebo-Controlled Pilot Study of the Effect of h5G1.1-mAb on Dermatomyositis PatientsDermatomyositisDrug: h5G1.1-mAbNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth17Phase 2United States
82NCT00004357September 199719 February 2015Absorption of Corticosteroids in Children With Juvenile DermatomyositisPhase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile DermatomyositisVasculitis, Hypersensitivity;Connective Tissue Diseases;Dermatomyositis;VasculitisDrug: Methylprednisolone;Drug: PrednisoloneNorthwestern UniversityAnn & Robert H Lurie Children's Hospital of ChicagoNot recruiting4 Years21 YearsBoth6Phase 2United States
83NCT00001421June 199519 February 2015Methimazole to Treat Polymyositis and DermatomyositisA Pilot Study of the Role of Methimazole in Patients With Polymyositis and DermatomyositisDermatomyositis;PolymyositisDrug: methimazoleNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/ABoth20Phase 2United States
84NCT00001261May 199019 February 2015Intravenousimmunoglobulin (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)Not recruitingN/AN/ABoth120Phase 2United States

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