50. 皮膚筋炎／多発性筋炎 ［臨床試験数：84，薬物数：124（DrugBank：38），標的遺伝子数：47，標的パスウェイ数：139］
Searched query = "Dermatomyositis", "Polymyositis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04033926 | December 2019 | 11 November 2019 | A Phase 2 Study of KZR-616 to Evaluate Safety and Efficacy in Patients With Active Polymyositis or Dermatomyositis | A 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 Dermatomyositis | Polymyositis;Dermatomyositis | Drug: KZR-616;Drug: Placebo | Kezar Life Sciences, Inc. | Recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States | |
| 2 | NCT04044690 | October 21, 2019 | 11 November 2019 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) | Dermatomyositis | Drug: human immunoglobulin G;Drug: Placebo | CSL Behring | Recruiting | 18 Years | N/A | All | 126 | Phase 3 | United States;Japan | |
| 3 | NCT02418273 | August 1, 2019 | 16 December 2017 | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders | Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders: a Pilot Study | Osteoporosis;Juvenile Rheumatoid Arthritis;Dermatomyositis;Polyarthritis;Systemic Lupus Erythematosis;Vasculitis;Glucocorticoid-induced Osteoporosis | Drug: denosumab | Indiana University | Not recruiting | 4 Years | 16 Years | All | 24 | Phase 1/Phase 2 | United States | |
| 4 | NCT03981744 | July 26, 2019 | 11 November 2019 | A Study of Ustekinumab in Participants With Active Polymyositis and Dermatomyositis Who Have Not Adequately Responded to One or More Standard-of-care Treatments | A 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 | Polymyositis;Dermatomyositis | Drug: Ustekinumab 6 mg/kg;Drug: Ustekinumab 90 mg;Drug: Placebo IV;Drug: Placebo SC | Janssen Pharmaceutical K.K. | Recruiting | 18 Years | 75 Years | All | 50 | Phase 3 | Japan | |
| 5 | EUCTR2018-003273-10-HU | 05/04/2019 | 30 April 2019 | A study of safety and efficacy of lenabasum in dermatomyositis patients | A 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 Pharmaceutical Form: Capsule INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Lenabasum Product Code: JBT-101 Pharmaceutical Form: Capsule INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Corbus Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 150 | Phase 3 | Serbia;United States;Spain;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03816345 | April 4, 2019 | 11 November 2019 | Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer | A 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 Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 264 | Phase 1 | United States | |
| 7 | NCT03813160 | December 17, 2018 | 30 September 2019 | Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Dermatomyositis | Dermatomyositis | Drug: Lenabasum 20 mg;Drug: Lenabasum 5 mg;Drug: Placebo | Corbus Pharmaceuticals Inc. | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Hungary | |
| 8 | NCT03817424 | December 13, 2018 | 30 September 2019 | A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis | A 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 Dermatomyositis | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis | Drug: VIB7734;Drug: Placebo | Viela Bio | Recruiting | 18 Years | 75 Years | All | 32 | Phase 1 | United States;Poland;Spain | |
| 9 | EUCTR2017-002710-31-DE | 20/08/2018 | 26 November 2018 | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS. | Dermatomyositis MedDRA version: 20.0 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Octanorm 16.5% Pharmaceutical Form: Solution for injection INN or Proposed INN: Human Normal Immunoglobulin CAS Number: 308067-58-5 Current Sponsor code: Octanorm 16.5% Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Concentration unit: % percent Concentration type: equal Concentration number: 16.5- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Octapharma Pharmazeutika Produktionsges.m.b.H | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Romania;Russian Federation;Netherlands;Germany | |||
| 10 | NCT03686969 | August 2, 2018 | 4 March 2019 | Study Evaluating Efficacy and Safety of 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 (SCGAM-02) | Dermatomyositis | Drug: Octanorm;Other: Placebo | Octapharma | Not recruiting | 18 Years | 80 Years | All | 1 | Phase 3 | Russian Federation;Czechia;Germany;Hungary;Poland;Romania | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03529955 | June 12, 2018 | 29 April 2019 | Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis | A Phase 2, Open Label Single Arm Study for Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis | Dermatomyositis, Adult Type | Drug: Apremilast 30mg | Tulane University | Recruiting | 18 Years | 75 Years | All | 10 | Phase 2 | United States | |
| 12 | NCT03857854 | June 5, 2018 | 11 March 2019 | Efficacy 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: Placebos | Beijing Continent Pharmaceutical Co, Ltd. | Recruiting | 18 Years | 65 Years | All | 152 | Phase 3 | China | |
| 13 | JPRN-UMIN000032193 | 2018/04/11 | 16 July 2019 | Efficacy 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 | Efficacy 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 disease | Patients 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 Medicine | Recruiting | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan | |
| 14 | JPRN-UMIN000032022 | 2018/04/01 | 16 July 2019 | Efficacy 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 | Efficacy 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 disease | Arm 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 Medicine | Recruiting | 20years-old | 80years-old | Male and Female | 66 | Not selected | Japan | |
| 15 | NCT03430388 | January 31, 2018 | 6 May 2019 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | Not recruiting | 2 Years | 60 Years | All | 600 | N/A | Brazil | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03181893 | January 23, 2018 | 22 July 2019 | A Study In Adults With Moderate To Severe Dermatomyositis | A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS WITH DERMATOMYOSITIS | Dermatomyositis | Drug: PF-06823859;Drug: Placebo Arm | Pfizer | Recruiting | 18 Years | 80 Years | All | 30 | Phase 2 | United States | |
| 17 | NCT03267277 | October 5, 2017 | 4 November 2019 | Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis | An Open-label Study of Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis | Juvenile Dermatomyositis;Dermatomyositis;Idiopathic Inflammatory Myopathies | Drug: Sodium Thiosulfate | National Institute of Environmental Health Sciences (NIEHS) | Recruiting | 7 Years | 99 Years | All | 250 | Phase 2 | United States | |
| 18 | ChiCTR1800016629 | 2017-07-01 | 18 June 2018 | An observation of tofacitinib in patients of MDA5+ clinically amyopathic dermatomyositis with interstitial lung disease | An observation of tofacitinib in patients of MDA5+ clinically amyopathic dermatomyositis with interstitial lung disease | dermatomyositis | study group:tofacitinib;control group:glucocorticoids+immunosuppressant; | Ren Ji Hospital South Campus, Shanghai Jiaotong University School of Medicine | Recruiting | 18 | 80 | Both | study group:15;control group:35; | Post-market | China | |
| 19 | NCT03192657 | July 2017 | 16 December 2017 | Basiliximab Treating Interstitial Pneumonia of CADM | Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients | Lung; Disease, Interstitial, With Fibrosis;Dermatomyositis | Drug: Basiliximab;Drug: Calcineurin Inhibitors;Drug: Steroids | RenJi Hospital | Not recruiting | 18 Years | 65 Years | All | 100 | Phase 2 | China | |
| 20 | NCT02980198 | May 3, 2017 | 7 October 2019 | Study of IFN-K in Dermatomyositis | A 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 | Biological: IFN-Kinoid;Other: Placebo;Other: ISA 51 | Neovacs | Not recruiting | 18 Years | 65 Years | All | 30 | Phase 2 | France;Germany;Italy;Switzerland;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2015-003277-15-SE | 12/04/2017 | 20 August 2018 | A Phase 2 Study of IMO-8400 in Patients with Dermatomyositis | A 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 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: IMO-8400 Current Sponsor code: IMO-8400 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: IMO-8400 Product Code: IMO-8400 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: IMO-8400 Current Sponsor code: IMO-8400 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | Idera Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Hungary;Czech Republic;United Kingdom;Sweden | |||
| 22 | NCT02971683 | March 13, 2017 | 26 August 2019 | Trial 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 Myopathy | 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) | Polymyositis;Dermatomyositis;Autoimmune Necrotizing Myopathy;Overlap Myositis;Juvenile Myositis Above the Age of 18 | Drug: Abatacept subcutaneous;Drug: Placebo | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States;Australia;Brazil;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Sweden | |
| 23 | JPRN-JapicCTI-173670 | 01/3/2017 | 16 July 2019 | Trial 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 Myopathy | 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) | Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18 | Intervention 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. | Recruiting | 18 | BOTH | 150 | Phase 3 | |||
| 24 | NCT02728752 | February 27, 2017 | 15 July 2019 | Study 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) | Dermatomyositis | Drug: Octagam 10%;Other: Placebo | Octapharma | Not recruiting | 18 Years | N/A | All | 94 | Phase 3 | United States;Canada;Czechia;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine;Czech Republic;France;Romania | |
| 25 | NCT03002649 | January 2017 | 30 September 2019 | Study of Tofacitinib in Refractory Dermatomyositis | Study of Tofacitinib in Refractory Dermatomyositis (STIR): Proof of Concept, Open-Label Study of 10 Patients | Dermatomyositis | Drug: Tofacitinib | Johns Hopkins University | Pfizer | Not recruiting | 18 Years | N/A | All | 10 | Phase 1 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT03092154 | January 2017 | 3 December 2018 | Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis | Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis | Treatment Side Effects | Drug: Lipid-lowering agents (Artovastatin) | University of Sao Paulo | Recruiting | 18 Years | N/A | All | 40 | N/A | Brazil | |
| 27 | EUCTR2016-002902-37-CZ | 20/12/2016 | 28 February 2019 | CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS (ProDERM Study) | PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF OCTAGAM 10% IN PATIENTS WITH DERMATOMYOSITIS - (ProDERM Study) | Dermatomyositis MedDRA version: 20.0 Level: LLT Classification code 10001403 Term: Adult dermatomyositis System Organ Class: 100000004858 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Octagam 10% Pharmaceutical Form: Solution for infusion INN or Proposed INN: IMMUNOGLOBULIN G CAS Number: 308067-58-5 Concentration unit: % percent Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous drip use (Noncurrent) | Octapharma Pharmazeutika Produktionsges.m.b.H. | Authorised | Female: yes Male: yes | 94 | Phase 3 | France;United States;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany | |||
| 28 | EUCTR2015-003277-15-GB | 02/09/2016 | 28 February 2019 | A Phase 2 Study of IMO-8400 in Patients with Dermatomyositis | A 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 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: IMO-8400 Current Sponsor code: IMO-8400 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: IMO-8400 Product Code: IMO-8400 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: IMO-8400 Current Sponsor code: IMO-8400 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | Idera Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Hungary;Czech Republic;United Kingdom;Sweden | |||
| 29 | NCT02780674 | August 26, 2016 | 12 February 2018 | A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases | A Phase 1, Randomized, Blinded, Single-Dose, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases | Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc | Biological: MEDI7734;Biological: Placebo | MedImmune LLC | Not recruiting | 18 Years | 65 Years | All | 36 | Phase 1 | United States | |
| 30 | EUCTR2015-003277-15-HU | 12/08/2016 | 21 May 2018 | A Phase 2 Study of IMO-8400 in Patients with Dermatomyositis | A 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 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: IMO-8400 Current Sponsor code: IMO-8400 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Idera Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Czech Republic;Hungary;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT03027674 | August 2016 | 16 December 2017 | Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud | Color Doppler Ultrasound Comparison of Topical 10 % Nifedipine Versus 5% Sildenafil in Secondary Raynaud: A Randomized, Double-blind, Placebo-controlled Pilot Study | Raynaud Phenomenon Due to Trauma;Raynaud Disease;System; Sclerosis;Lupus Erythematosus, Systemic;Dermatomyositis;Ultrasound Therapy; Complications | Drug: 10% nifedipine cream;Drug: 5% sildenafil cream | Pontificia Universidad Catolica de Chile | Not recruiting | 13 Years | 99 Years | All | 10 | Early Phase 1 | Chile | |
| 32 | EUCTR2016-000137-52-DE | 26/07/2016 | 8 January 2018 | Phase IIa exploratory study to assess the safety and effect of IFNa-Kinoid (IFN-K) in adult patients with Dermatomyositis | A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNa-Kinoid (IFN-K) in Adult Subjects with Dermatomyositis. | Dermatomyositis MedDRA version: 19.1 Level: PT Classification code 10012503 Term: Dermatomyositis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFNa-Kinoid Product Code: IFN-K Pharmaceutical Form: Emulsion for injection INN or Proposed INN: Not yet assigned Current Sponsor code: IFN-K DS Other descriptive name: IFN-Kinoid Drug Substance Concentration unit: µg/ml microgram(s)/millilitre Concentration type: not less then Concentration number: 380- Pharmaceutical form of the placebo: Emulsion for injection Route of administration of the placebo: Intramuscular use | Neovacs SA | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Germany;Italy;United Kingdom;Switzerland | |||
| 33 | NCT02821689 | July 2016 | 11 July 2016 | Pirfenidone in Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis | Randomized Controlled Trial of Pirfenidone in Patients With Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis | Dermatopolymyositis;Interstitial Lung Disease | Drug: Pirfenidone | RenJi Hospital | Not recruiting | 16 Years | N/A | Both | 57 | Phase 4 | China | |
| 34 | NCT02594735 | November 2015 | 4 February 2019 | Abatacept in Juvenile Dermatomyositis | Abatacept for the Treatment of Refractory Juvenile Dermatomyositis | Dermatomyositis | Drug: Abatacept | George Washington University | Recruiting | 7 Years | N/A | All | 10 | Phase 4 | United States | |
| 35 | NCT02612857 | November 2015 | 22 October 2019 | Trial of IMO-8400 in Adult Patients With Dermatomyositis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients With Dermatomyositis | Dermatomyositis | Drug: IMO-8400 Dose Group 1;Drug: IMO-8400 Dose Group 2;Drug: Placebo | Idera Pharmaceuticals, Inc. | Not recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | United States;Hungary;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | JPRN-UMIN000018376 | 2015/07/22 | 23 April 2019 | Efficacy and safety of rituximab for patients with severe rheumatic disease | Efficacy 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 Pediatrics | Not Recruiting | 2years-old | Not applicable | Male and Female | 20 | Not selected | Japan | |
| 37 | NCT02245841 | June 2015 | 23 April 2019 | Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis | Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis | Dermatomyositis;Juvenile Dermatomyositis | Drug: H.P. Acthar Gel | The Cleveland Clinic | Mallinckrodt | Recruiting | 18 Years | N/A | All | 15 | Phase 4 | United States |
| 38 | NCT02466243 | June 2015 | 25 February 2019 | Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis | A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis | Dermatomyositis | Drug: JBT-101;Drug: Placebo | Corbus Pharmaceuticals Inc. | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);University of Pennsylvania | Not recruiting | 18 Years | 70 Years | All | 22 | Phase 2 | United States |
| 39 | NCT02267005 | March 2015 | 11 June 2018 | The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis | The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis | Juvenile Dermatomyositis | Dietary Supplement: Creapure;Dietary Supplement: Glucose Tablet | The Hospital for Sick Children | Not recruiting | 7 Years | 18 Years | All | 13 | N/A | Canada | |
| 40 | EUCTR2015-003424-31-GB | 28 February 2019 | Treatment of autoinflammatory diseases | Treatment 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 Pharmaceutical Form: Coated tablet INN or Proposed INN: Baricitinib Current Sponsor code: LY3009104 Other descriptive name: BARICITINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- INN or Proposed INN: Baricitinib Current Sponsor code: LY3009104 Other descriptive name: BARICITINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- INN or Proposed INN: baricitinib Current Sponsor code: LY3009104 Other descriptive name: BARICITINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Eli Lilly and Company | Not Available | Female: yes Male: yes | 60 | Phase 2 | France;United States;United Kingdom | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT02271165 | November 2014 | 11 June 2018 | Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study | Dermatomyositis | Drug: Immunoglobulin (Hizentra) | Thomas Jefferson University | Not recruiting | 18 Years | N/A | All | 2 | Early Phase 1 | United States | ||
| 42 | JPRN-UMIN000015469 | 2014/10/20 | 10 September 2019 | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease | Comparison 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 disease | arm1: 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 Medicine | Not Recruiting | 18years-old | 75years-old | Male and Female | 50 | Not selected | Japan | |
| 43 | NCT02043548 | October 1, 2014 | 30 September 2019 | Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis | Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis | Dermatomyositis;Polymyositis | Drug: tocilizumab;Drug: placebo | Chester Oddis | Genentech, Inc. | Not recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
| 44 | ChiCTR-IPR-16007958 | 2014-06-01 | 18 April 2017 | An observation of Pirfenidone in patients with rapidly progressive interstitial lung disease secondary to clinically amyopathic dermatomyositis | An observation of Pirfenidone in patients with rapidly progressive interstitial lung disease secondary to clinically amyopathic dermatomyositis | clinically amyopathic dermatomyositis | Rsearch group: glucocorticoids+immunosuppressant+pirfenidone;Control group: glucocorticoids+immunosuppressant; | Renji Hospital, Shanghai Jiaotong University School of Medicine | Not Recruiting | Both | Rsearch group:30;Control group:30; | Post-market | China | |||
| 45 | JPRN-UMIN000013546 | 2014/06/01 | 2 April 2019 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | Not Recruiting | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT02159651 | April 1, 2014 | 30 September 2019 | A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia | Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis | Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis | Drug: tacrolimus | Astellas Pharma Inc | Not recruiting | N/A | N/A | All | 179 | Phase 2/Phase 3 | Japan | |
| 47 | EUCTR2013-001799-39-HU | 26/09/2013 | 11 April 2016 | Study 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Siponimod CAS Number: 1234627-85-0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Code: BAF312 0.50 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Siponimod CAS Number: 1234627-85-0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Code: BAF312 1mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Siponimod CAS Number: 1234627-85-0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Code: BAF312 2mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Siponimod CAS Number: 1234627-85-0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.0- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 56 | United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Belgium;Netherlands;Germany;Japan;China;Switzerland | ||||
| 48 | EUCTR2012-005772-34-SE | 04/09/2013 | 11 April 2016 | A 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 Level: PT Classification code 10036102 Term: Polymyositis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 Pharmaceutical Form: Solution for injection INN or Proposed INN: gevokizumab CAS Number: 1129435-60-4 Current Sponsor code: S78989 Other descriptive name: XOMA 052 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Institut de Recherches Internationales Servier (IRIS) | Not Recruiting | Female: yes Male: yes | 40 | Greece;Spain;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden | ||||
| 49 | NCT01906372 | September 2013 | 16 December 2017 | Acthar in Treatment of Refractory Dermatomyositis and Polymyositis | Open Label Proof of Concept Study to Evaluate Efficacy and Safety of Adrenocorticotropic Hormone Gel in Refractory Dermatomyositis or Polymyositis | Dermatomyositis;Polymyositis | Drug: Adrenocorticotropic Hormone Gel | Rohit Aggarwal, MD | Mallinckrodt | Not recruiting | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 50 | ChiCTR-TRC-13003178 | 2013-05-01 | 18 April 2017 | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Polymyositis/Dermatomyositis | group1-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 hospital | Recruiting | 18 | 70 | Both | group1-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; | Other | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT01801917 | April 24, 2013 | 18 January 2018 | Efficacy and Tolerability of BAF312 in Patients With Polymyositis | A Multi-centre Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis | Polymyositis | Drug: Placebo;Drug: BAF312 | Novartis Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 14 | Phase 2 | United States;Canada;Czechia;Hungary;Poland;Taiwan;Belgium;Czech Republic;Netherlands;Switzerland | |
| 52 | NCT01637064 | April 2013 | 17 November 2015 | Dermatomyositis and Polymyositis Registry | Acthar Dermatomyositis and Polymyositis Treatment | Dermatomyositis;Polymyositis | Drug: Acthar | Phoenix Neurological Associates, LTD | Recruiting | 18 Years | 85 Years | Both | 100 | N/A | United States | |
| 53 | EUCTR2012-002859-42-HU | 25/01/2013 | 21 November 2016 | Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositis | A 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Siponimid CAS Number: 1234627-85-0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAF312 1 mg tablet Product Code: BAF312X Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Siponimod CAS Number: 1234627-85-0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Czech Republic;Hungary;Canada;Belgium;Poland | |||
| 54 | NCT01724580 | October 25, 2012 | 17 September 2018 | Compassionate Use Protocol for the Treatment of Autoinflammatory Syndromes | Compassionate 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 Dermatomyositis | Chronic 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: Baricitinib | Eli Lilly and Company | Not recruiting | 6 Months | N/A | All | Phase 1 | United States;United Kingdom | ||
| 55 | NCT01572844 | August 2012 | 16 December 2017 | Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis | Novel Drug Delivery of Sodium Thiosulfate for Calcinosis Associated With Adult and Juvenile Dermatomyositis | Calcinosis | Device: Fractionated Carbon Dioxide (FCO2) Laser;Drug: Sodium thiosulfate | Alison Ehrlich | Not recruiting | 18 Years | 65 Years | All | 3 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT01217320 | January 2011 | 19 February 2015 | Creatine Supplementation in Pediatric Rheumatology | Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis | Juvenile Systemic Lupus Erythematosus;Juvenile Dermatomyositis | Dietary Supplement: creatine;Dietary Supplement: placebo (dextrose) | University of Sao Paulo | Recruiting | 6 Years | 18 Years | Both | 40 | N/A | Brazil | |
| 57 | JPRN-UMIN000031931 | 2010/12/01 | 2 April 2019 | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis | Dermatomyositis | Cyclophosphamide 2g/m2, 2 days Harvest of autologous hematopoietic stem cells Cyclophosphamide 50mg/kg, 4 days Transplantation of autologous hematopoietic stem cells | Kyushu University | Not Recruiting | 16years-old | 65years-old | Male and Female | 10 | Phase 2 | Japan | ||
| 58 | NCT01813617 | September 2010 | 19 February 2015 | Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis | Outcome of Muscle Function and Disease Activity in Patients With Recent Onset Polymyositis and Dermatomyositis - a 1-year Follow-up Register Study | Polymyositis;Dermatomyositis | Drug: Immunosuppressive Agents | Karolinska University Hospital | Not recruiting | 18 Years | N/A | Both | 72 | N/A | Sweden | |
| 59 | NCT01151644 | April 2010 | 19 February 2015 | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Rheumatoid 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 DM | Biological: Anti-pandemic H1N1 influenza vaccine | University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Not recruiting | N/A | N/A | Both | 5000 | Phase 4 | Brazil |
| 60 | EUCTR2009-015957-20-SE | 16/02/2010 | 26 June 2012 | Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS | Abatacept treatment in polymyositis and dermatomyositis - ARTEMIS | polymyositis and dermatomyositis MedDRA version: 12.1 Level: LLT Classification code 10036102 Term: Polymyositis MedDRA version: 12.1 Level: LLT Classification code 10012503 Term: Dermatomyositis | Trade Name: ORENCIA Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: ABATACEPT CAS Number: 332348-12-6 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | Karolinska University Hospital | Authorised | Female: yes Male: yes | 20 | United Kingdom;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT01140503 | February 2010 | 19 October 2017 | A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With Dermatomyositis | An Open Label Study Evaluating the Safety and Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Dermatomyositis | Dermatomyositis | Drug: Apremilast | Stanford University | Not recruiting | 18 Years | N/A | All | 5 | N/A | United States | |
| 62 | EUCTR2008-006311-21-GB | 28/07/2009 | 9 October 2012 | A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositis - | Polymyositis and dermatomyositis MedDRA version: 9.1 Level: LLT Classification code 10036102 Term: Polymyositis MedDRA version: 9.1 Level: LLT Classification code 10012503 Term: Dermatomyositis | Product Name: BAF312 5 mg tablet Product Code: BAF312 Pharmaceutical Form: Film-coated tablet Current Sponsor code: BAF312 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAF312 4mg tablet Product Code: BAF312 Pharmaceutical Form: Film-coated tablet Current Sponsor code: BAF312 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAF312 1 mg tablet Product Code: BAF312 Pharmaceutical Form: Film-coated tablet Current Sponsor code: BAF312 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAF312 0.25 mg tablet Product Code: BAF312 Pharmaceutical Form: Film-coated tablet Current Sponsor code: BAF312 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Novartis Pharma Services AG | Authorised | Female: yes Male: yes | 45 | Hungary;Czech Republic;United Kingdom;Sweden | |||||
| 63 | JPRN-UMIN000001866 | 2009/04/01 | 5 November 2019 | Continuous 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 - 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 Medicine | Not Recruiting | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan | |
| 64 | EUCTR2008-001282-28-NL | 23/09/2008 | 19 March 2012 | Influenza, pneumococcal and hepatitis B vaccination in patients with rheumatic autoimmune diseases treated with immunosuppressive therapy - Vaccinations in rheumatic autoimmune diseases | Influenza, 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 Pharmaceutical Form: INN or Proposed INN: Influvac Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0,5- Trade Name: Pneumovax 23 Pharmaceutical Form: INN or Proposed INN: Pneumovax 23 Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0,5- Trade Name: HBvaxpro Pharmaceutical Form: INN or Proposed INN: HBVAXPRO Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 10- | Radboud University Nijmegen Medical Centre | Authorised | Female: yes Male: yes | Netherlands | |||||
| 65 | NCT00651040 | May 2008 | 19 October 2017 | Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM | A 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;Dermatomyositis | Drug: Prednisone;Drug: Methotrexate | Institute of Rheumatology, Prague | Karolinska Institutet | Not recruiting | 18 Years | 80 Years | All | 31 | Phase 3 | Czech Republic |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT00533091 | April 2008 | 19 February 2015 | A Study to Evaluate Safety of Multi-Dose MEDI-545 in Adult Patients With Dermatomyositis or Polymyositis | A 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 Polymyositis | DERMATOMYOSITIS OR POLYMYOSITIS | Biological: MEDI-545;Other: Placebo | MedImmune LLC | Not recruiting | 18 Years | N/A | Both | 51 | Phase 1 | United States | |
| 67 | EUCTR2007-004410-13-CZ | 12/03/2008 | 19 March 2012 | A 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 | A 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 Level: LLT Classification code 10036102 Term: Polymyositis | Trade Name: Methotrexat Lachema 2,5mg Product Name: Methotrexat Lachema 2,5mg tbl. Product Code: 44/154/85-C Pharmaceutical Form: Tablet INN or Proposed INN: METHOTREXATE CAS Number: 59052 Current Sponsor code: 01 Other descriptive name: methotrexate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2,5- Trade Name: Prednison 5, 20 Léciva por. tablet nob. Product Name: Prednison 5, 20 Léciva por. tablet nob. Product Code: 56/104/75-C Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob CAS Number: 53032 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Name: Methotrexat Lachema 5 inj. sol Product Name: Methotrexate Lachema 5inj. sol Product Code: 44/196/81-C Pharmaceutical Form: Solution for injection INN or Proposed INN: methotrexate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Solu-medrol inj. PSO LQF 40mg Product Name: Solu-medrol inj. PSO lqf 40mg Pharmaceutical Form: Intravenous infusion INN or Proposed INN: methylprednisoloni natrii succinas Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- | Institute od Rheumatology Prague | Authorised | Female: yes Male: yes | 50 | Czech Republic;Sweden | ||||
| 68 | JPRN-JMA-IIA00012 | 20/07/2007 | 5 November 2019 | Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus | An 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/dermatomyositis | Intervention 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 office | Hokkaido 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 Dentistry | Not Recruiting | >=16 YEARS | <75 YEARS | BOTH | 20 | Phase 2-3 | Japan |
| 69 | NCT00504348 | July 2007 | 16 December 2017 | Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus | An 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;Polymyositis;Dermatomyositis | Drug: Tacrolimus | Tokyo Medical and Dental University | Japan Medical Association;Astellas Pharma Inc | Not recruiting | 16 Years | 74 Years | All | 26 | Phase 2/Phase 3 | Japan |
| 70 | EUCTR2006-000078-65-SE | 17/01/2007 | 19 March 2012 | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis | Rituximab 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Rituximab Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Karolinska University Hospital | Not Recruiting | Female: yes Male: yes | 202 | United Kingdom;Czech Republic;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2005-003956-37-NL | 26/09/2006 | 14 August 2012 | Five 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 | Five 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 onset | Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration number: 5- Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Methylprednisolone CAS Number: 2921-57-5 Concentration unit: mg milligram(s) Concentration number: 8- Pharmaceutical Form: Capsule, soft INN or Proposed INN: Ciclosporin CAS Number: 59865-59-5 Concentration unit: mg milligram(s) Concentration number: 10- Pharmaceutical Form: Oral solution INN or Proposed INN: Ciclosporin CAS Number: 59865-59-5 Concentration unit: mg milligram(s) Concentration number: 100- Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Ciclosporin CAS Number: 59865-59-5 Concentration unit: mg milligram(s) Concentration number: 50- Pharmaceutical Form: Solution for injection INN or Proposed INN: Methotrexate Concentration unit: mg milligram(s) Concentration number: 5- Pharmaceutical Form: Solution for injection INN or Proposed INN: Methotrexate Concentration unit: mg milligram(s) Concentration number: 5- | Istituto Giannina Gaslini | Authorised | Female: yes Male: yes | 160 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | |||
| 72 | EUCTR2005-002463-88-DE | 18/07/2006 | 19 March 2012 | 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 | 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 strength under conventional therapy (Glucocorticosteroids associated with immunosuppressors). | Trade Name: Ig VENA Product Name: Ig VENA (10g/200mL) Product Code: L0133 Pharmaceutical Form: Solution for infusion Current Sponsor code: L0133 Other descriptive name: Human normal immunoglobulin (IVIg) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Orfagen | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria | ||||
| 73 | NCT00335985 | June 2006 | 19 February 2015 | Efficacy 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 Dermatomyositis | Polymyositis;Dermatomyositis | Drug: GB-0998;Drug: Placebo of GB-0998 | Japan Blood Products Organization | Not recruiting | 16 Years | 75 Years | Both | 26 | Phase 3 | Japan | |
| 74 | NCT00323960 | May 2006 | 19 February 2015 | Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis | Five-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 | Drug: 3 MPDN pulse + PDN;Drug: 3 MPDN pulse + PDN + CSA;Drug: 3 MPDN pulse + PDN + MTX | Istituto Giannina Gaslini | Pediatric Rheumatology International Trials Organization | Recruiting | 1 Year | 18 Years | Both | 120 | Phase 3 | Italy |
| 75 | NCT00106184 | March 2006 | 19 October 2017 | Rituximab 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 Dermatomyositis | Drug: Rituximab;Drug: Placebo | University of Pittsburgh | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Genentech, Inc.;Biogen | Not recruiting | 5 Years | N/A | All | 200 | Phase 2 | United States;Canada;Czech Republic;Sweden;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT00112385 | March 2006 | 19 October 2017 | A Pilot Study of Etanercept in Dermatomyositis | A Pilot Study of Etanercept in Dermatomyositis | Dermatomyositis | Drug: Etanercept;Drug: Placebo | Brigham and Women's Hospital | Amgen | Not recruiting | 18 Years | 65 Years | All | 16 | Phase 1 | United States |
| 77 | NCT01165008 | September 2003 | 19 February 2015 | Anakinra in Myositis | Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies | Polymyositis;Dermatomyositis;Inclusion Body Myositis | Drug: Anakinra | Karolinska Institutet | Not recruiting | 18 Years | 80 Years | Both | Phase 2/Phase 3 | Sweden | ||
| 78 | NCT00035958 | August 2002 | 19 February 2015 | Understanding the Pathogenesis and Treatment of Childhood Onset Dermatomyositis | Toward Improved Understanding of Pathogenesis and Treatment of Childhood Onset Dermatomyositis | Dermatomyositis | Drug: Prednisone;Drug: Methotrexate;Drug: Etanercept | Children's Hospital Medical Center, Cincinnati | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Immunex Corporation | Not recruiting | 4 Years | 16 Years | Both | 75 | Phase 2/Phase 3 | United States |
| 79 | NCT00033891 | April 10, 2002 | 11 November 2019 | Infliximab (Remicade ) to Treat Dermatomyositis and Polymyositis | A Randomized, Double-Blind, Placebo-Controlled Trial of Infliximab in Patients With Dermatomyositis and Polymyositis | Dermatomyositis;Polymyositis | Drug: Infliximab | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | 18 Years | N/A | All | 14 | Phase 2 | United States | |
| 80 | NCT00138983 | May 2000 | 19 February 2015 | Prevention 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 Granulomatosis | Drug: Alendronate versus alfacalcidol (1-alpha OH vitamin D) | UMC Utrecht | Dutch Health Care Insurance Board | Not recruiting | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT00005571 | April 2000 | 19 February 2015 | Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis | A Randomized, Third-Party-Blind, Placebo-Controlled Pilot Study of the Effect of h5G1.1-mAb on Dermatomyositis Patients | Dermatomyositis | Drug: h5G1.1-mAb | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 17 | Phase 2 | United States | |
| 82 | NCT00004357 | September 1997 | 19 February 2015 | Absorption of Corticosteroids in Children With Juvenile Dermatomyositis | Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis | Vasculitis, Hypersensitivity;Connective Tissue Diseases;Dermatomyositis;Vasculitis | Drug: Methylprednisolone;Drug: Prednisolone | Northwestern University | Ann & Robert H Lurie Children's Hospital of Chicago | Not recruiting | 4 Years | 21 Years | Both | 6 | Phase 2 | United States |
| 83 | NCT00001421 | June 1995 | 19 February 2015 | Methimazole to Treat Polymyositis and Dermatomyositis | A Pilot Study of the Role of Methimazole in Patients With Polymyositis and Dermatomyositis | Dermatomyositis;Polymyositis | Drug: methimazole | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Not recruiting | N/A | N/A | Both | 20 | Phase 2 | United States | |
| 84 | NCT00001261 | May 1990 | 19 February 2015 | Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies | The Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-Over | Dermatomyositis;Inclusion Body Myositis;Polymyositis | Drug: Gamma Globulin | National Institute of Neurological Disorders and Stroke (NINDS) | Not recruiting | N/A | N/A | Both | 120 | Phase 2 | United States |