50. 皮膚筋炎/多発性筋炎
[臨床試験数:157,薬物数:207(DrugBank:76),標的遺伝子数:47,標的パスウェイ数:142

Searched query = "Dermatomyositis", "Polymyositis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
1ChiCTR2000036282
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
2NCT04628936
(ClinicalTrials.gov)
November 4, 20202/11/2020Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.An Open-label Extension to the 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-616Kezar Life Sciences, Inc.NULLEnrolling by invitation18 YearsN/AAll24Phase 2United States
3NCT04613219
(ClinicalTrials.gov)
October 1, 202015/9/2020Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung DiseaseCorrelation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung DiseaseClinically Amyopathic Dermatomyisitis(CAMD)Drug: Tofacitinib 5 MG [Xeljanz]Jing LiangNULLRecruiting18 Years80 YearsAll80China
4ChiCTR2000036709
2020-10-012020-08-24Study on early warning of rapid progressive interstitial lung disease in dermatomyositisStudy on early warning of rapid progressive interstitial lung disease in dermatomyositis DermatomyositisGroup 1:Glucocorticoid + cyclophosphamide + cyclosporin;Group 2:Glucocorticoid + cyclophosphamide + Tofacitinib;Zhongshan Hospital of Fudan UniversityNULLPending1860BothGroup 1:15;Group 2:15;N/AChina
5EUCTR2020-001762-11-GB
(EUCTR)
17/09/202023/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2020-001762-11-HU
(EUCTR)
26/08/202002/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
7JPRN-jRCTs031200005
30/04/202010/04/2020Investigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositisInvestigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositis - ACDM Dermatomyositis
Collagen disease, inflammatory myopathy, cutaneous manifestation;D003882
Oral administration of apremilast: Start with 10 mg of oral dose and gradually increase the dose until day 5, 30mg twice a day from day 6 (morning / evening) for a total of 12 weeksOkiyama NaokoNULLNot Recruiting>= 20age old< 80age oldBoth5Japan
8ChiCTR2000031286
2020-03-272020-03-26Establishment and validation of the risk prediction model of dermatomyositis combined with malignant tumor nomogramEstablishment and validation of the risk prediction model of dermatomyositis combined with malignant tumor nomogram DermatomyositicGold Standard:Clinical outcomes (whether combined with malignant tumor);Index test:The risk prediction model of dermatomyositis combined with malignant tumor nomogram;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNULLRecruiting851BothTarget condition:240;Difficult condition:0China
9EUCTR2019-002605-22-CZ
(EUCTR)
28/01/202029/11/2019A study to evaluate the saftey and efficacy of KZR-616 for the tretament of patients with active inflammations of the muscle and the skin (rheumatic disease)A Phase 2 Randomized, Double-blind, Placebo-controlled,Crossover Multicenter Study to Evaluate the Safety and Efficacy ofKZR-616 in the Treatment of Patients with Active Polymyositis orDermatomyositis Autoimmune Disorders Polymyositis and Dermatomyositis
MedDRA version: 20.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: KZR-616
INN or Proposed INN: KZR-616
Other descriptive name: KZR-616 maleate
Product Name: KZR-616
INN or Proposed INN: KZR-616
Other descriptive name: KZR-616 maleate
Kezar Life Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;Czechia;Hungary;Czech Republic;Poland;Germany
10EUCTR2018-003171-35-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;Switzerland;United Kingdom;France;European Union;Mexico;Argentina;Australia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04033926
(ClinicalTrials.gov)
January 14, 202023/7/2019A 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.NULLRecruiting18 YearsN/AAll24Phase 2United States;Czechia;Germany;Poland
12NCT03582800
(ClinicalTrials.gov)
January 6, 202013/6/2018Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot StudySubcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot StudySystemic Sclerosis;Dermatomyositis;iPPSD2Drug: STSUniversity Hospital, LimogesNULLRecruiting6 MonthsN/AAll40Phase 2France
13ChiCTR1900028143
2020-01-012019-12-13Effect of Tacrolimus on dermatomyositis/polymyositisA Single-center, randomized, controlled trial for Tacrolimus in patients with dermatomyositis/polymyositis dermatomyositis/polymyositisControl group:glucocorticoid ;Treatment group:Glucocorticoid+Tacrolimus;Control group:Glucocorticoid+Cyclophosphamide;Department of Rheumatology and Immunology, Tianjin Medical University General HospitalNULLPending1870BothControl group:20;Treatment group:20;Control group:20;Phase 4China
14EUCTR2018-003171-35-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]
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
126Phase 3United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan
15EUCTR2018-003273-10-DE
(EUCTR)
06/11/201911/12/2018A 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 subjects Dermatomyositis (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
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Serbia;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04044690
(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;Germany;Italy;Japan;Russian Federation;Switzerland;Ukraine
17EUCTR2018-003273-10-SE
(EUCTR)
30/09/201918/03/2019A 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 subjects Dermatomyositis (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]
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3United States;Serbia;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
18EUCTR2018-003171-35-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]
CSL Behring LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
126Phase 3United States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland
19ChiCTR1900025087
2019-09-012019-08-10Cyclosporine A in the treatment of polymyositis /dermatomyositis associated interstitial pulmonary disease: a prospective, opened, multicenter, randomized, controlled clinical studyCyclosporine A in the Treatment of Polymyositis /Dermatomyositis With Interstitial Lung Disease (CTP /DMILD): a Prospective, Opened, Randomized, Multicenter, Controlled Trial Polymyositis/Dermatomyositis associated Interstitial Lung Diseasetreatment group:CsA+glucocorticoid;control group:CTX+glucocorticoid;Guangdong Provincial People's HospitalNULLPendingBothtreatment group:75;control group:75;Phase 4China
20JPRN-JapicCTI-194822
27/8/201925/06/2019A 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 Treatments PolymyositisDermatomyositisIntervention name : Ustekinumab
INN of the intervention : Ustekinumab
Dosage And administration of the intervention : Group 1: Ustekinumab + Placebo Group 2: Placebo + Ustekinumab Participants will receive body weight-range based IV dosing of 6 mg/kg of ustekinumab at Week 0 in Group 1 and at Week 24 in Group 2.
Control intervention name : placebo IV
INN of the control intervention : -
Dosage And administration of the control intervention : Group 1: Ustekinumab + Placebo Group 2: Placebo + Ustekinumab Participants will receive IV dosing of placebo at Week 24 in Group 1 and at Week 0 in Group 2.
Control intervention name : Placebo SC
INN of the control intervention : -
Dosage And administration of the control intervention : Group 2: Placebo + Ustekinumab Participants will receive SC dosing of placebo at Weeks 8,16 and 24.
Janssen Pharmaceutical K.K.NULLrecruiting1875BOTH50Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02418273
(ClinicalTrials.gov)
August 1, 20196/4/2015Denosumab 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 UniversityNULLWithdrawn4 Years16 YearsAll0Phase 1;Phase 2United States
22EUCTR2018-001978-22-FR
(EUCTR)
31/07/201917/09/2018Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study.Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study. - ITS Pilot Patient presenting with: - ectopic ossification secondary to iPPSD2 or - ectopic calcification secondary to dermatomyositis or - ectopic calcification secondary to systemic sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10006935;Term: Calcification and ossification, unspecified;System Organ Class: 100000004867 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
CHU de LIMOGESNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40Phase 2France
23NCT03981744
(ClinicalTrials.gov)
July 26, 20197/6/2019A 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.NULLRecruiting18 Years75 YearsAll50Phase 3Japan
24EUCTR2018-003273-10-CZ
(EUCTR)
27/05/201906/02/2019A 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 subjects Dermatomyositis (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
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Serbia;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
25EUCTR2018-003273-10-GB
(EUCTR)
21/05/201920/11/2018A 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 subjects Dermatomyositis (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]
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3Serbia;United States;Spain;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-003273-10-ES
(EUCTR)
16/05/201911/04/2019A 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 subjects Dermatomyositis (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]
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3Serbia;United States;Spain;Switzerland;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
27EUCTR2018-003273-10-BG
(EUCTR)
13/05/201918/03/2019A 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 subjects Dermatomyositis (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
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Serbia;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;Italy;France;Australia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
28EUCTR2018-003273-10-HU
(EUCTR)
05/04/201906/02/2019A 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 subjects Dermatomyositis (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]
Corbus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished 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
29NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab 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)NULLRecruiting18 YearsN/AAll264Phase 1United States
30NCT03813160
(ClinicalTrials.gov)
December 17, 201821/1/2019Trial 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.NULLActive, not recruiting18 YearsN/AAll176Phase 3United States;Bulgaria;Canada;Czechia;Germany;Hungary;Italy;Japan;Korea, Republic of;Poland;Spain;Sweden;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A 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 BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain
32EUCTR2017-002710-31-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
33NCT03686969
(ClinicalTrials.gov)
August 2, 201831/8/2018Study 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: PlaceboOctapharmaNULLTerminated18 Years80 YearsAll1Phase 3Russian Federation;Czechia;Germany;Hungary;Poland;Romania
34EUCTR2017-002710-31-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
35EUCTR2016-002902-37-NL
(EUCTR)
28/06/201824/01/2018CLINICAL 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]
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
94Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2017-002710-31-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
37NCT03529955
(ClinicalTrials.gov)
June 12, 201824/4/2018Evaluating 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 UniversityNULLRecruiting18 Years75 YearsAll10Phase 2United States
38NCT03857854
(ClinicalTrials.gov)
June 5, 201826/2/2019Efficacy 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.NULLRecruiting18 Years65 YearsAll152Phase 3China
39JPRN-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
40JPRN-UMIN000032022
2018/04/0101/04/2018Efficacy 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-ILD anti-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 MedicineNULLRecruiting20years-old80years-oldMale and Female66Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03430388
(ClinicalTrials.gov)
January 31, 201830/1/2018Yellow 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 HospitalNULLCompleted2 Years60 YearsAll600N/ABrazil
42NCT03181893
(ClinicalTrials.gov)
January 23, 20185/6/2017A Study In Adults With Moderate To Severe DermatomyositisA PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITISDermatomyositisDrug: PF-06823859 low;Drug: Placebo Arm;Drug: PF-06823859 highPfizerNULLRecruiting18 Years80 YearsAll30Phase 2United States
43NCT03267277
(ClinicalTrials.gov)
October 5, 201729/8/2017Sodium 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 DermatomyositisDermatomyositis;Idiopathic Inflammatory MyopathiesDrug: Sodium ThiosulfateNational Institute of Environmental Health Sciences (NIEHS)NULLRecruiting7 Years99 YearsAll250Phase 2United States
44EUCTR2016-002269-77-FR
(EUCTR)
02/09/201711/02/2019A 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of
45EUCTR2016-002269-77-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]
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3France;United States;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2016-002269-77-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]
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
150Phase 3France;United States;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Korea, Republic of;Sweden
47EUCTR2016-002269-77-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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3France;United States;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Korea, Republic of;Sweden
48ChiCTR1800016629
2017-07-012018-06-14An 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 disease dermatomyositisstudy group:tofacitinib;control group:glucocorticoids+immunosuppressant;Ren Ji Hospital South Campus, Shanghai Jiaotong University School of MedicineNULLRecruiting1880Bothstudy group:15;control group:35;China
49NCT03192657
(ClinicalTrials.gov)
July 201715/6/2017Basiliximab 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 HospitalNULLNot yet recruiting18 Years65 YearsAll100Phase 2China
50NCT02980198
(ClinicalTrials.gov)
May 3, 201725/11/2016Study 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 51NeovacsNULLWithdrawn18 Years65 YearsAll0Phase 2France;Germany;Italy;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2015-003277-15-SE
(EUCTR)
12/04/201722/06/2016A Phase 2 Study of IMO-8400 in Patients with DermatomyositisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients 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] - Skin and Connective Tissue Diseases [C17]
Product Name: IMO-8400
Product Code: IMO-8400
INN or Proposed INN: IMO-8400
Product Name: IMO-8400
Product Code: IMO-8400
INN or Proposed INN: IMO-8400
Idera Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2United States;Hungary;Czech Republic;United Kingdom;Sweden
52NCT02971683
(ClinicalTrials.gov)
March 13, 201721/11/2016Trial 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 SquibbNULLActive, not recruiting18 YearsN/AAll150Phase 3United States;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Sweden;Hungary
53JPRN-JapicCTI-173670
01/3/201709/08/2017Trial 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
Dosage And administration of the control intervention : Placebo of Abatacept subcutaneous + Standard Treatment
Bristol-Myers Squibb K.K.NULLrecruiting18BOTH150Phase 3NULL
54NCT02728752
(ClinicalTrials.gov)
February 27, 201711/3/2016Study 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: PlaceboOctapharmaNULLCompleted18 YearsN/AAll95Phase 3United States;Canada;Czechia;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Ukraine;Czech Republic;France
55EUCTR2016-002902-37-DE
(EUCTR)
21/02/201729/09/2016CLINICAL 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]
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
94Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2016-002902-37-HU
(EUCTR)
09/02/201719/12/2016CLINICAL 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: 19.0;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%
INN or Proposed INN: IMMUNOGLOBULIN G
Trade Name: Octagam 10%
INN or Proposed INN: IMMUNOGLOBULIN G
Trade Name: Octagam 10%
INN or Proposed INN: IMMUNOGLOBULIN G
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
94Phase 3France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Germany
57NCT03002649
(ClinicalTrials.gov)
January 201720/12/2016Study of Tofacitinib in Refractory DermatomyositisStudy of Tofacitinib in Refractory Dermatomyositis (STIR): Proof of Concept, Open-Label Study of 10 PatientsDermatomyositisDrug: TofacitinibJohns Hopkins UniversityPfizerCompleted18 YearsN/AAll10Phase 1United States
58NCT03092154
(ClinicalTrials.gov)
January 20179/3/2017Lipid-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 PauloNULLRecruiting18 YearsN/AAll40N/ABrazil
59EUCTR2016-002902-37-CZ
(EUCTR)
20/12/201626/09/2016CLINICAL 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]
Octapharma Pharmazeutika Produktionsges.m.b.H.NULLNot Recruiting Female: yes
Male: yes
94Phase 3France;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany
60ChiCTR-DDD-16009687
2016-10-282016-10-28The precision diagnosis of dermatomyositis with malignant tumor or fatal interstitial lung diseaseThe precision diagnosis of dermatomyositis with malignant tumor or fatal interstitial lung disease DermatomyositisGold Standard:;Index test:;Department of Dermatology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong UniversityNULLRecruiting18BothTarget condition:0;Difficult condition:0China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2015-003277-15-GB
(EUCTR)
02/09/201631/12/2015A Phase 2 Study of IMO-8400 in Patients with DermatomyositisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients 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] - Skin and Connective Tissue Diseases [C17]
Idera Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
36Phase 2United States;Hungary;Czech Republic;United Kingdom;Sweden
62NCT02780674
(ClinicalTrials.gov)
August 26, 20163/5/2016A 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: PlaceboViela BioMedImmune LLCCompleted18 Years65 YearsAll36Phase 1United States
63EUCTR2015-003277-15-HU
(EUCTR)
12/08/201620/06/2016A Phase 2 Study of IMO-8400 in Patients with DermatomyositisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with Dermatomyositis Dermatomyositis
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
INN or Proposed INN: IMO-8400
Idera Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
36Phase 2United States;Czech Republic;Hungary;United Kingdom;Sweden
64NCT03027674
(ClinicalTrials.gov)
August 201613/1/2017Topical 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 ChileNULLCompleted13 Years99 YearsAll10Early Phase 1Chile
65EUCTR2016-000137-52-DE
(EUCTR)
26/07/201606/06/2016Phase 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]
Neovacs SANULLNot Recruiting Female: yes
Male: yes
30Phase 2France;Germany;Italy;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT02821689
(ClinicalTrials.gov)
July 201621/6/2016Pirfenidone 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 HospitalNULLNot yet recruiting16 YearsN/ABoth57Phase 4China
67NCT02612857
(ClinicalTrials.gov)
November 201518/11/2015Trial 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.NULLCompleted18 Years75 YearsAll30Phase 2United States;Hungary;United Kingdom
68NCT02594735
(ClinicalTrials.gov)
November 201521/10/2015Abatacept in Juvenile DermatomyositisAbatacept for the Treatment of Refractory Juvenile DermatomyositisDermatomyositisDrug: AbataceptGeorge Washington UniversityNULLRecruiting7 YearsN/AAll10Phase 4United States
69JPRN-UMIN000018376
2015/07/2222/07/2015Efficacy 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 disease Childhood-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 PediatricsNULLComplete: follow-up complete2years-oldNot applicableMale and Female20Not selectedJapan
70NCT02466243
(ClinicalTrials.gov)
June 20152/6/2015Safety, 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 PennsylvaniaActive, not recruiting18 Years70 YearsAll22Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT02245841
(ClinicalTrials.gov)
June 201511/9/2014Efficacy 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
72NCT02267005
(ClinicalTrials.gov)
March 20151/10/2014The 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 ChildrenNULLCompleted7 Years18 YearsAll13N/ACanada
73EUCTR2012-005772-34-BE
(EUCTR)
03/12/201413/10/2014A 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 disease Polymyositis / 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;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
40Greece;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden
74EUCTR2012-005772-34-GR
(EUCTR)
11/11/201420/10/2014A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis diseaseA 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 or dermatomyositis disease Polymyositis / Dermatomyositis
MedDRA version: 17.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.0;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
40Greece;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden
75NCT02271165
(ClinicalTrials.gov)
November 201415/10/2014Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept StudyDermatomyositisDrug: Immunoglobulin (Hizentra)Thomas Jefferson UniversityNULLTerminated18 YearsN/AAll2Early Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76JPRN-UMIN000015469
2014/10/2018/10/2014Comparison 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-ILD polymyositis/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 MedicineNULLComplete: follow-up complete18years-old75years-oldMale and Female50Not selectedJapan
77EUCTR2013-001799-39-BE
(EUCTR)
16/10/201402/09/2014Study 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 dermatomyositis Active 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
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
56Phase 2United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium;Germany;Japan
78EUCTR2012-002859-42-BE
(EUCTR)
16/10/201425/08/2014Study 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 polymyositis Polymyositis
MedDRA version: 18.0;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
INN or Proposed INN: Siponimid
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 1 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 2 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 0,5 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium
79NCT02043548
(ClinicalTrials.gov)
October 1, 201417/1/2014Tocilizumab in the Treatment of Refractory Polymyositis and DermatomyositisTocilizumab in the Treatment of Refractory Polymyositis and DermatomyositisDermatomyositis;PolymyositisDrug: tocilizumab;Drug: placeboChester OddisGenentech, Inc.Completed18 YearsN/AAll36Phase 2United States
80JPRN-UMIN000013546
2014/06/0131/03/2014The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus rheumatoid 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 HospitalNULLPending16years-old80years-oldMale and Female20Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81ChiCTR-IPR-16007958
2014-06-012016-02-21An 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 dermatomyositis clinically amyopathic dermatomyositisRsearch group: glucocorticoids+immunosuppressant+pirfenidone;Control group: glucocorticoids+immunosuppressant;Renji Hospital, Shanghai Jiaotong University School of MedicineNULLCompletedBothRsearch group:30;Control group:30;China
82NCT02159651
(ClinicalTrials.gov)
April 1, 20146/6/2014A 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 IncNULLCompletedN/AN/AAll179Japan
83EUCTR2013-001799-39-PL
(EUCTR)
15/02/201413/01/2014Study 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. Active dermatomyositis
MedDRA version: 17.0;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
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
56United States;Hungary;Czech Republic;Canada;Poland;Germany;Japan
84EUCTR2012-005772-34-GB
(EUCTR)
21/01/201410/06/2013A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis or necrotizing autoimmune myopathy diseaseA 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 or dermatomyositis or necrotizing autoimmune myopathy disease Polymyositis / 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;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Servier Research and Development Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Hungary;Czech Republic;Greece;Belgium;Brazil;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
85EUCTR2013-001799-39-CZ
(EUCTR)
19/12/201308/10/2013Study 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. Active dermatomyositis
MedDRA version: 18.1;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
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312 0.5 mg
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312 1 mg
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312 2 mg
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
56United States;Hungary;Czech Republic;Canada;Poland;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2012-003633-42-GB
(EUCTR)
18/10/201322/08/2013A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseasesA randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Cyclophosphamide Injection 1g
Product Name: Cyclophosphamide Injection 1g
INN or Proposed INN: Cyclophosphamide
Royal Brompton and Harefield NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
87EUCTR2013-001799-39-HU
(EUCTR)
26/09/201308/08/2013Study 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 dermatomyositis Active 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
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312 0.50 mg
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312 1mg
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Code: BAF312 2mg
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
56United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Belgium;Netherlands;Germany;Japan;China;Switzerland
88EUCTR2012-005772-34-DE
(EUCTR)
09/09/201304/06/2013A 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 diseaseA 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 disease Polymyositis / 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;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
40France;Hungary;Czech Republic;Belgium;Brazil;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
89EUCTR2012-005772-34-SE
(EUCTR)
04/09/201303/06/2013A 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 disease Polymyositis / 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;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
40Greece;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden
90NCT01906372
(ClinicalTrials.gov)
September 20135/7/2013Acthar 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, MDMallinckrodtCompleted18 YearsN/AAll12Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT02029274
(ClinicalTrials.gov)
August 25, 20132/12/2013Safety and Efficacy of BAF312 in DermatomyositisA Double Blind, Randomized, Placebo-controlled Study to Evaluate, Safety, Tolerability, Efficacy and Preliminary Dose-response of BAF312 in Patients With Active Dermatomyositis (DM)Active DermatomyositisDrug: BAF312;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years75 YearsAll17Phase 2United States;Czechia;Japan;Belgium;Canada;China;Czech Republic;Hungary;Netherlands;Poland;Switzerland;Taiwan
92EUCTR2012-005772-34-HU
(EUCTR)
11/07/201312/06/2013A 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 myophaty diseaseA 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 myophaty disease Polymyositis / Dermatomyositis /necrotizing autoimmune myophaty
MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
40France;Czech Republic;Hungary;Belgium;Spain;Brazil;Denmark;Germany;United Kingdom;Italy;Sweden
93EUCTR2012-005772-34-ES
(EUCTR)
24/06/201310/06/2013A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis diseaseA 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 or dermatomyositis disease Polymyositis / Dermatomyositis
MedDRA version: 16.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 16.0;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Laboratorios Servier S.LInstitut de Recherches Internationales Servier (IRIS)Not RecruitingFemale: yes
Male: yes
40Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Brazil;Belgium;Denmark;Norway;Germany;Sweden
94EUCTR2012-005772-34-IT
(EUCTR)
17/06/201322/05/2013A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis diseaseA 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 or dermatomyositis disease Polymyositis / Dermatomyositis
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
40Phase 2Greece;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Argentina;Brazil;Belgium;Denmark;Norway;Germany;Sweden
95EUCTR2012-005772-34-CZ
(EUCTR)
06/06/201306/06/2013A 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 diseaseA 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 disease Polymyositis / Dermatomyositis / necrotizing autoimmune myopathy
MedDRA version: 18.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 18.0;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
INN or Proposed INN: gevokizumab
Other descriptive name: XOMA 052
Institut de Recherches Internationales Servier (IRIS)NULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Hungary;Czech Republic;Greece;Belgium;Spain;Brazil;Denmark;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2012-002859-42-PL
(EUCTR)
23/05/201304/02/2013Efficacy and tolerability for 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 polymyositis Polymyositis
MedDRA version: 19.0;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: Siponimod 0.25 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod 1 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod 2 mg Tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Product Name: Siponimod 0.5 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2United States;Hungary;Czech Republic;Taiwan;Canada;Belgium;Poland;Switzerland
97ChiCTR-TRC-13003178
2013-05-012013-01-03Study 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 study Polymyositis/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 hospitalNULLRecruiting1870Bothgroup1-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;China
98NCT01801917
(ClinicalTrials.gov)
April 24, 20131/2/2013Efficacy 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 PharmaceuticalsNULLTerminated18 Years75 YearsAll14Phase 2United States;Canada;Czechia;Hungary;Poland;Taiwan;Belgium;Czech Republic;Netherlands;Switzerland
99NCT01637064
(ClinicalTrials.gov)
April 20136/7/2012Dermatomyositis and Polymyositis RegistryActhar Dermatomyositis and Polymyositis TreatmentDermatomyositis;PolymyositisDrug: ActharPhoenix Neurological Associates, LTDNULLEnrolling by invitation18 Years85 YearsBoth100N/AUnited States
100EUCTR2012-002859-42-CZ
(EUCTR)
20/02/201318/12/2012Study 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 polymyositis Polymyositis
MedDRA version: 19.0;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
INN or Proposed INN: Siponimid
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 1 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2United States;Hungary;Czech Republic;Canada;Belgium;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2012-002859-42-HU
(EUCTR)
25/01/201305/11/2012Study 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 polymyositis Polymyositis
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
INN or Proposed INN: Siponimid
Other descriptive name: BAF312 hemifumarate
Product Name: BAF312 1 mg tablet
Product Code: BAF312X
INN or Proposed INN: Siponimod
Other descriptive name: BAF312 hemifumarate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Czech Republic;Hungary;Canada;Belgium;Poland
102NCT01572844
(ClinicalTrials.gov)
August 20124/4/2012Topical 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 EhrlichNULLCompleted18 Years65 YearsAll3Phase 2United States
103EUCTR2009-015957-20-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
104EUCTR2009-015957-20-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
105NCT01315938
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT01217320
(ClinicalTrials.gov)
January 20116/10/2010Creatine 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 PauloNULLRecruiting6 Years18 YearsBoth40N/ABrazil
107JPRN-UMIN000031931
2010/12/0127/03/2018Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis DermatomyositisCyclophosphamide 2g/m2, 2 days
Harvest of autologous hematopoietic stem cells
Cyclophosphamide 50mg/kg, 4 days
Transplantation of autologous hematopoietic stem cells
Kyushu UniversityNULLComplete: follow-up complete16years-old65years-oldMale and Female10Phase 2Japan
108NCT01813617
(ClinicalTrials.gov)
September 201013/3/2013Outcome 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 HospitalNULLCompleted18 YearsN/ABoth72N/ASweden
109NCT01148810
(ClinicalTrials.gov)
June 15, 201021/6/2010Efficacy and Tolerability of BAF312 in Patients With Polymyositis and DermatomyositisA Multi-centre, Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis and DermatomyositisPolymyositis;DermatomyositisDrug: BAF312;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years75 YearsAll18Phase 2United States;Czechia;Hungary;Sweden;United Kingdom;Czech Republic;Poland
110NCT01151644
(ClinicalTrials.gov)
April 201025/6/2010Safety 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 PauloActive, not recruitingN/AN/ABoth5000Phase 4Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2005-002463-88-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
112EUCTR2009-015957-20-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
113NCT01140503
(ClinicalTrials.gov)
February 20106/4/2010A 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 UniversityNULLTerminated18 YearsN/AAll5N/AUnited States
114EUCTR2005-002463-88-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
115EUCTR2008-006311-21-CZ
(EUCTR)
19/11/200915/09/2009A 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;Classification code 10012503;Term: Dermatomyositis
Product Name: BAF312 5 mg tablet
Product Code: BAF312
Product Name: BAF312 4mg tablet
Product Code: BAF312
Product Name: BAF312 1mg tablet
Product Code: BAF312
Product Name: BAF312 0.25mg tablet
Product Code: BAF312
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Hungary;United Kingdom;Czech Republic;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2008-006311-21-SE
(EUCTR)
28/10/200924/07/2009Study to test the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositisA 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: 14.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Product Name: BAF312
Product Code: BAF312
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Czech Republic;Hungary;United Kingdom;Sweden
117EUCTR2008-006311-21-HU
(EUCTR)
16/10/200928/07/2009A 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;Classification code 10012503;Term: Dermatomyositis
Product Name: BAF312
Product Code: BAF312
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Hungary;Czech Republic;United Kingdom;Sweden
118EUCTR2008-006311-21-GB
(EUCTR)
28/07/200926/06/2009A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositisA 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;Classification code 10012503;Term: Dermatomyositis
Product Name: BAF312 5 mg tablet
Product Code: BAF312
Product Name: BAF312 4mg tablet
Product Code: BAF312
Product Name: BAF312 1 mg tablet
Product Code: BAF312
Product Name: BAF312 0.25 mg tablet
Product Code: BAF312
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Hungary;United Kingdom;Sweden
119NCT01724580
(ClinicalTrials.gov)
June 20095/11/2012Compassionate 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 CompanyNULLNo longer available6 MonthsN/AAllUnited States;United Kingdom
120JPRN-UMIN000001866
2009/04/0110/04/2009Continuous 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 polymyositis Dermatomyositis 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 MedicineNULLComplete: follow-up complete16years-oldNot applicableMale and Female10Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2008-008169-36-NL
(EUCTR)
17/02/200929/12/2008Immune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV studyImmune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV study Juvenile Idiopathic ArthritisSystemic lupus erythematosus childhood dermatomyositis
MedDRA version: 9.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd
MedDRA version: 9.1;Classification code 10059176;Term: Juvenile idiopathic arthritis
MedDRA version: 9.1;Classification code 10008521;Term: Childhood dermatomyositis
Trade Name: Cervarix suspensie voor injectie
Product Name: not applicable
Product Code: not applicable
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: no
Netherlands
122EUCTR2006-000078-65-GB
(EUCTR)
08/12/200807/12/2010Rituximab 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 myositis Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis
MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis
Trade Name: Mabthera
Product Name: Mabthera
Karolinska University HospitalNULLNot RecruitingFemale: yes
Male: yes
202Phase 2Czech Republic;United Kingdom;Sweden
123EUCTR2008-001282-28-NL
(EUCTR)
23/09/200829/08/2008Influenza, 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 diseases Rheumatic autoimmune diseases including rheumatoid arthritis and poly or dermatomyositis.Trade Name: Influvac
INN or Proposed INN: Influvac
Trade Name: Pneumovax 23
INN or Proposed INN: Pneumovax 23
Trade Name: HBvaxpro
INN or Proposed INN: HBVAXPRO
Radboud University Nijmegen Medical CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
124EUCTR2007-004410-13-SE
(EUCTR)
06/08/200818/06/2008A 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. - PROMETHEUS active polymyositis, dermatomyositis
MedDRA version: 9.1;Level: LLT;Classification code 10012503;Term: Dermatomyositis
MedDRA version: 9.1;Classification code 10036102;Term: Polymyositis
Trade Name: Methotrexate Wyeth 2,5mg
Product Name: Methotrexate Wyeth 2,5mg tbl.
INN or Proposed INN: metotrexat
Trade Name: Prednisolon Pfizer
Product Name: prednisolon
INN or Proposed INN: prednisolon
Trade Name: Metoject 10 mg/ml
Product Name: metotrexat
INN or Proposed INN: metotrexat
Institute od Rheumatology PragueNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Czech Republic;Sweden
125EUCTR2005-003956-37-GB
(EUCTR)
18/06/200820/03/2008Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexateFive year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate Juvenile Dermatomyositis at onsetTrade Name: treatment defined only by active substance
Product Name: prednisone
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: methylprednisolone
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: cyclosporine A
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: cyclosporine A
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: methotrexate
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: methotrexate
Product Code: not available
INN or Proposed INN: not availa
Istituto Giannina GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT00651040
(ClinicalTrials.gov)
May 200831/3/2008Combined 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 InstitutetCompleted18 Years80 YearsAll31Phase 3Czech Republic
127NCT00533091
(ClinicalTrials.gov)
April 200820/9/2007A 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 LLCNULLCompleted18 YearsN/ABoth51Phase 1United States
128EUCTR2007-004410-13-CZ
(EUCTR)
12/03/200825/10/2007A 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. - PROMETHEUS active polymyositis, dermatomyositis
MedDRA version: 9.1;Level: LLT;Classification code 10012503;Term: Dermatomyositis
MedDRA version: 9.1;Classification code 10036102;Term: Polymyositis
Trade Name: Methotrexat Lachema 2,5mg
Product Name: Methotrexat Lachema 2,5mg tbl.
Product Code: 44/154/85-C
INN or Proposed INN: METHOTREXATE
Other descriptive name: methotrexate
Trade Name: Prednison 5, 20 Léciva por. tablet nob.
Product Name: Prednison 5, 20 Léciva por. tablet nob.
Product Code: 56/104/75-C
INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob
Trade Name: Methotrexat Lachema 5 inj. sol
Product Name: Methotrexate Lachema 5inj. sol
Product Code: 44/196/81-C
INN or Proposed INN: methotrexate
Trade Name: Solu-medrol inj. PSO LQF 40mg
Product Name: Solu-medrol inj. PSO lqf 40mg
INN or Proposed INN: methylprednisoloni natrii succinas
Institute od Rheumatology PragueNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Czech Republic;Sweden
129EUCTR2006-000078-65-CZ
(EUCTR)
12/11/200718/10/2007Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM)Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM) Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis.
MedDRA version: 9.1;Level: LLT;Classification code 10036102;Term: Polymyositis
Trade Name: Mabthera
Product Code: Mabthera
Karolinska University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
202United Kingdom;Czech Republic;Sweden
130JPRN-JMA-IIA00012
20/07/200705/07/2007Investigation 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 controls Interstitial 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 DentistryCompleted>=16 YEARS<75 YEARSBOTH20Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT00504348
(ClinicalTrials.gov)
July 200719/7/2007Investigation 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 IncCompleted16 Years74 YearsAll25Phase 2;Phase 3Japan
132EUCTR2005-003956-37-SE
(EUCTR)
23/02/200711/12/2006Five 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 methotrexateFive 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 methotrexate Juvenile Dermatomyositis at onsetTrade Name: treatment defined only by active substance
Product Name: Prednisone
Product Code: Not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: methylprednisolone
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: Cyclosporine A
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: not available
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: Cyclosporine A
Product Code: not available
INN or Proposed INN: not available
Other descriptive name: not available
Trade Name: treatment defined only by active substance
Product Name: Methotrexate
Product Code: not available
Istituto Giannina GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
133EUCTR2006-000078-65-SE
(EUCTR)
17/01/200702/11/2006Rituximab 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 myositis Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis
MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis
Trade Name: Mabthera
Product Name: Mabthera
INN or Proposed INN: Rituximab
Karolinska University HospitalNULLNot RecruitingFemale: yes
Male: yes
202United Kingdom;Czech Republic;Sweden
134EUCTR2005-003956-37-BE
(EUCTR)
13/11/200625/10/2006Five 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 methotrexate - PRINTO JDM TrialFive 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 methotrexate - PRINTO JDM Trial Juvenile Dermatomyositis at onsetProduct Name: Prednisolone
INN or Proposed INN: Methylprednisolone
Product Name: Methylprednisolone
INN or Proposed INN: Methylprednisolone sodium succinate
Product Name: Cyclosporine
INN or Proposed INN: Cyclosporine A
Product Name: Cyclosporine
INN or Proposed INN: Cyclosporine A
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
University Hospital GentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
135EUCTR2005-003956-37-DK
(EUCTR)
03/11/200615/09/2006Five 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 methotrexateFive 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 methotrexate Juvenile Dermatomyositis at onsetProduct Name: Prednisone
Product Name: methylprednisolone
Product Name: Cyclosporine
Product Name: Cyclosporine
Product Name: Cyclosporine
Product Name: Metotrexate
Product Name: Methotrexate
Istituto Giannina GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3Belgium;Denmark;Netherlands;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2005-003956-37-NL
(EUCTR)
26/09/200601/06/2006Five 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 mehotrexate Juvenile Dermatomyositis at onsetINN or Proposed INN: Prednisone
INN or Proposed INN: Methylprednisolone
INN or Proposed INN: Ciclosporin
INN or Proposed INN: Ciclosporin
INN or Proposed INN: Ciclosporin
INN or Proposed INN: Methotrexate
INN or Proposed INN: Methotrexate
Istituto Giannina GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
137EUCTR2005-002463-88-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
138EUCTR2005-002463-88-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
139NCT00335985
(ClinicalTrials.gov)
June 20068/6/2006Efficacy 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 OrganizationNULLCompleted16 Years75 YearsBoth26Phase 3Japan
140EUCTR2005-003956-37-IT
(EUCTR)
02/05/200612/09/2006FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - NDFIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND New Onset juvenile dermatomyositis
MedDRA version: 6.1;Level: PT;Classification code 10012503
INN or Proposed INN: Prednisone
INN or Proposed INN: Methylprednisolone
INN or Proposed INN: Ciclosporin
INN or Proposed INN: Ciclosporin
INN or Proposed INN: Ciclosporin
INN or Proposed INN: Methotrexate
INN or Proposed INN: Methotrexate
ISTITUTO GIANNINA GASLININULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT00323960
(ClinicalTrials.gov)
May 20069/5/2006Five-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
142EUCTR2005-003129-23-GB
(EUCTR)
18/04/200624/02/2006To prevent and treat osteoporosis in children with rhuematic diseases taking steroidsPrevention and Treatment of Steroid-Induced Osteopenia in children and adolescents with rheumatic diseases - POPS Children and adolescents with Juvenile Idiopathic arthritis (JIA), Juvenile dermatomyositis (JDMS) Juvenile systemic lupus erythematosis (JSLE) Vasculitis;Therapeutic area: Body processes [G] - Immune system processes [G12]Belfast Health and Social Care Trust, Musgrave Park HospitalNULLNot Recruiting Female: yes
Male: yes
216Phase 4United Kingdom
143NCT00106184
(ClinicalTrials.gov)
March 200621/3/2005Rituximab 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.;BiogenCompleted5 YearsN/AAll200Phase 2United States;Canada;Czech Republic;Sweden;United Kingdom
144NCT00112385
(ClinicalTrials.gov)
March 20062/6/2005A Pilot Study of Etanercept in DermatomyositisA Pilot Study of Etanercept in DermatomyositisDermatomyositisDrug: Etanercept;Drug: PlaceboBrigham and Women's HospitalAmgenCompleted18 Years65 YearsAll16Phase 1United States
145EUCTR2005-002463-88-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT01165008
(ClinicalTrials.gov)
September 200316/7/2010Anakinra in MyositisAnakinra in Patients With Refractory Idiopathic Inflammatory MyopathiesPolymyositis;Dermatomyositis;Inclusion Body MyositisDrug: AnakinraKarolinska InstitutetNULLCompleted18 Years80 YearsBothPhase 2;Phase 3Sweden
147NCT00035958
(ClinicalTrials.gov)
August 20027/5/2002Understanding 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 CorporationTerminated4 Years16 YearsBoth75Phase 2;Phase 3United States
148NCT00033891
(ClinicalTrials.gov)
April 10, 200211/4/2002Infliximab (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)NULLCompleted18 YearsN/AAll14Phase 2United States
149NCT00138983
(ClinicalTrials.gov)
May 200029/8/2005Prevention 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 BoardCompleted18 Years90 YearsBoth200Phase 3Netherlands
150NCT00005571
(ClinicalTrials.gov)
April 200025/4/2000Safety 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)NULLCompletedN/AN/ABoth17Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT00004357
(ClinicalTrials.gov)
September 199718/10/1999Absorption 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 ChicagoCompleted4 Years21 YearsBoth6Phase 2United States
152NCT00001421
(ClinicalTrials.gov)
June 19953/11/1999Methimazole 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)NULLCompletedN/AN/ABoth20Phase 2United States
153NCT00001261
(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
154EUCTR2020-001762-11-SE
(EUCTR)
17/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
155EUCTR2020-001762-11-DE
(EUCTR)
17/09/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2020-001762-11-AT
(EUCTR)
10/08/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
157EUCTR2015-003424-31-GB
(EUCTR)
07/12/2015Treatment of autoinflammatory diseasesTreatment of Conditions Expected to Benefit from JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis - JAGA CANDLE, 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
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
INN or Proposed INN: baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
60Phase 2France;United States;United Kingdom