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"
75 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR20000362822020-12-012020-08-22A 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
2NCT04628936November 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
3EUCTR2019-002605-22-CZ28/01/202029/11/2019A 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: 20.0Level: HLGTClassification code 10003816Term: Autoimmune disordersSystem 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
4NCT04033926January 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
5EUCTR2018-003273-10-DE06/11/201911/12/2018A 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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
6NCT04044690October 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
7EUCTR2018-003273-10-SE30/09/201918/03/2019A 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
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited 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
8JPRN-JapicCTI-19482227/8/201925/06/2019A 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
9NCT03981744July 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
10EUCTR2018-003273-10-CZ27/05/201906/02/2019A 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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
11EUCTR2018-003273-10-GB21/05/201920/11/2018A 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
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Spain;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
12EUCTR2018-003273-10-ES16/05/201911/04/2019A 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
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Spain;Switzerland;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
13EUCTR2018-003273-10-BG13/05/201918/03/2019A 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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
14EUCTR2018-003273-10-HU05/04/201906/02/2019A 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
150 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noSerbia;United States;Spain;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of
15NCT03813160December 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
16NCT03817424December 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
17EUCTR2017-002710-31-DE20/08/201824/05/2018DOUBLE-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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
18NCT03686969August 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
19EUCTR2017-002710-31-HU10/07/201819/07/2018DOUBLE-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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
20EUCTR2016-002902-37-NL28/06/201824/01/2018CLINICAL 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
94 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;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
21EUCTR2017-002710-31-CZ27/06/201801/06/2018DOUBLE-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: 20.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
22NCT03857854June 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
23NCT03181893January 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
24NCT02980198May 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
25EUCTR2015-003277-15-SE12/04/201722/06/2016A 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: 19.1Level: PTClassification code 10012503Term: DermatomyositisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02971683March 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
27JPRN-JapicCTI-17367001/3/201709/08/2017Trial 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
28NCT02728752February 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
29EUCTR2016-002902-37-DE21/02/201729/09/2016CLINICAL 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
94 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany
30EUCTR2016-002902-37-HU09/02/201719/12/2016CLINICAL 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: 19.0Level: LLTClassification code 10001403Term: Adult dermatomyositisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2016-002902-37-CZ20/12/201626/09/2016CLINICAL 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
94 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany
32EUCTR2015-003277-15-GB02/09/201631/12/2015A 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
36 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Czech Republic;United Kingdom;Sweden
33NCT02780674August 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
34EUCTR2015-003277-15-HU12/08/201620/06/2016A 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: 19.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
35NCT03027674August 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT02612857November 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
37NCT02466243June 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
38EUCTR2012-005772-34-BE03/12/201413/10/2014A 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: 17.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1Level: PTClassification code 10036102Term: PolymyositisSystem 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
39EUCTR2012-005772-34-GR11/11/201420/10/2014A 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: 17.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.0Level: PTClassification code 10036102Term: PolymyositisSystem 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
40EUCTR2012-002859-42-BE16/10/201425/08/2014Study 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: 18.0Level: PTClassification code 10036102Term: PolymyositisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2013-001799-39-BE16/10/201402/09/2014Study 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: 18.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
42NCT02043548October 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
43EUCTR2013-001799-39-PL15/02/201413/01/2014Study 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: 17.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
44EUCTR2012-005772-34-GB21/01/201410/06/2013A 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: 17.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1Level: PTClassification code 10036102Term: PolymyositisSystem 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
45EUCTR2013-001799-39-CZ19/12/201308/10/2013Study 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: 18.1Level: PTClassification code 10012503Term: DermatomyositisSystem 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
46EUCTR2013-001799-39-HU26/09/201308/08/2013Study 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: 18.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
47EUCTR2012-005772-34-DE09/09/201304/06/2013A 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: 17.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1Level: PTClassification code 10036102Term: PolymyositisSystem 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
48EUCTR2012-005772-34-SE04/09/201303/06/2013A 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: 17.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1Level: PTClassification code 10036102Term: PolymyositisSystem 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
49NCT02029274August 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
50EUCTR2012-005772-34-HU11/07/201312/06/2013A 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: 17.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 17.1Level: PTClassification code 10036102Term: PolymyositisSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2012-005772-34-ES24/06/201310/06/2013A 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: 16.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 16.0Level: PTClassification code 10036102Term: PolymyositisSystem 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
52EUCTR2012-005772-34-IT17/06/201322/05/2013A 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: 14.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1Level: PTClassification code 10036102Term: PolymyositisSystem 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
53EUCTR2012-005772-34-CZ06/06/201306/06/2013A 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: 18.0Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 18.0Level: PTClassification code 10036102Term: PolymyositisSystem 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
54EUCTR2012-002859-42-PL23/05/201304/02/2013Efficacy 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: 19.0Level: PTClassification code 10036102Term: PolymyositisSystem 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
55NCT01801917April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2012-002859-42-CZ20/02/201318/12/2012Study 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: 19.0Level: PTClassification code 10036102Term: PolymyositisSystem 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
57EUCTR2012-002859-42-HU25/01/201305/11/2012Study 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: 14.1Level: PTClassification code 10036102Term: PolymyositisSystem 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
58NCT01217320January 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
59NCT01148810June 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
60EUCTR2005-002463-88-HU11/03/201001/10/2009Efficacy 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2005-002463-88-CZ16/12/200905/10/2009Efficacy 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
62EUCTR2008-006311-21-CZ19/11/200915/09/2009A 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: 9.1Level: LLTClassification code 10036102Term: Polymyositis
MedDRA version: 9.1Level: LLTClassification code 10012503Term: 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
63EUCTR2008-006311-21-SE28/10/200924/07/2009Study 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: 14.0Level: PTClassification code 10036102Term: PolymyositisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.0Level: PTClassification code 10012503Term: DermatomyositisSystem 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
64EUCTR2008-006311-21-HU16/10/200928/07/2009A 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: 9.1Level: LLTClassification code 10036102Term: Polymyositis
MedDRA version: 9.1Level: LLTClassification code 10012503Term: Dermatomyositis
Product Name: BAF312
Product Code: BAF312
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
45Hungary;Czech Republic;United Kingdom;Sweden
65EUCTR2008-006311-21-GB28/07/200926/06/2009A 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: 9.1Level: LLTClassification code 10036102Term: Polymyositis
MedDRA version: 9.1Level: LLTClassification code 10012503Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT00533091April 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
67EUCTR2005-002463-88-IT17/08/200621/04/2006fficacy 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: 14.1Level: HLTClassification code 10003821Term: Muscular autoimmune disordersSystem 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
68EUCTR2005-002463-88-DE18/07/200628/12/2005Efficacy 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
69NCT00335985June 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
70NCT00106184March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT00112385March 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
72EUCTR2005-002463-88-AT02/02/200617/01/2006Efficacy 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
73NCT00033891April 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
74NCT00138983May 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
75NCT00005571April 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