50. 皮膚筋炎／多発性筋炎 Dermatomyositis Clinical trials / Disease details
臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05669014 (ClinicalTrials.gov) | April 2023 | 20/12/2022 | A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM) | A Phase 2, Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of Daxdilimab Subcutaneous Injection in Adult Participants With Inadequately Controlled Dermatomyositis or Anti-synthetase Inflammatory Myositis. | Idiopathic Inflammatory Myositis | Drug: Daxdilimab;Drug: Placebo | Horizon Therapeutics Ireland DAC | NULL | Not yet recruiting | 18 Years | 75 Years | All | 96 | Phase 2 | NULL |
| 2 | NCT05695950 (ClinicalTrials.gov) | February 27, 2023 | 13/1/2023 | A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis | A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3667 Once Daily for 24 Weeks in Adult Subjects With Dermatomyositis | Dermatomyositis | Drug: GLPG3667;Drug: Placebo | Galapagos NV | NULL | Recruiting | 18 Years | 75 Years | All | 62 | Phase 2 | United States |
| 3 | EUCTR2018-003171-35-HU (EUCTR) | 13/02/2023 | 14/12/2022 | 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) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | Argentina;Russian Federation;Hungary;United States;Japan;Ukraine;United Kingdom;Switzerland;Spain;Belgium;European Union;Mexico;Italy;Australia;France;Germany | ||
| 4 | NCT05650567 (ClinicalTrials.gov) | January 19, 2023 | 6/12/2022 | Study of M5049 in DM and PM Participants (NEPTUNIA) | A Phase IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants Receiving Standard of Care (NEPTUNIA) | Dermatomyositis;Polymyositis | Drug: M5049 high dose;Drug: Placebo | EMD Serono Research & Development Institute, Inc. | Merck KGaA, Darmstadt, Germany | Recruiting | 18 Years | 75 Years | All | 40 | Phase 2 | United States;Germany |
| 5 | NCT05495321 (ClinicalTrials.gov) | December 1, 2022 | 17/11/2021 | Interleukin-2 on Active Dermatomyositis | Therapeutic Effect of Interleukin-2 on Active Dermatomyositis: A Multicenter, Randomised, Double-blind, Placebo-controlled Trial | Dermatomyositis | Drug: Interleukin-2 | Peking University People's Hospital | NULL | Enrolling by invitation | 18 Years | 75 Years | All | 240 | Phase 3 | China |
| 6 | NCT05524311 (ClinicalTrials.gov) | November 10, 2022 | 5/7/2022 | Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT) | Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis | Juvenile Dermatomyositis | Drug: Baricitinib;Biological: pharmacokinetics study;Biological: dosage of cytokines;Biological: transcriptomic analysis;Behavioral: Parent version of the Child Health Questionnaire (CHQ);Behavioral: Childhood Health Assessment Questionnaire;Biological: Pregnancy test | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 3 Years | 18 Years | All | 16 | Phase 2 | France |
| 7 | NCT05437263 (ClinicalTrials.gov) | October 31, 2022 | 24/6/2022 | A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Brepocitinib in Adults With Dermatomyositis | Dermatomyositis | Drug: Brepocitinib;Drug: Placebo | Priovant Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 225 | Phase 3 | United States;Bulgaria;Czechia;Germany;Hungary;Israel;Italy;Poland;Romania;Slovakia;Spain |
| 8 | NCT04972760 (ClinicalTrials.gov) | August 31, 2022 | 14/6/2021 | Baricitinib in Patients With Relapsing or naïve Dermatomyositis | Baricitinib in Patients With Relapsing or naïve Dermatomyositis: a Multicenter Randomized Controlled Trial (BIRD) | Dermatomyositis | Drug: Baricitinib;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | 74 Years | All | 62 | Phase 3 | France |
| 9 | EUCTR2021-004787-10-ES (EUCTR) | 04/05/2022 | 08/02/2022 | An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study | AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS =18 AND =80 WITH ACTIVE 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: PF-06823859 Product Code: PF-06823859 INN or Proposed INN: PF-06823859 Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;Hungary;Poland;Spain;Australia;Germany;Italy | ||
| 10 | NCT05361109 (ClinicalTrials.gov) | May 1, 2022 | 3/4/2022 | Baricitinib for Cutaneous Dermatomyositis | An Open-Label Pilot Study to Evaluate the Efficacy and Safety of Baricitinib in Subjects With Cutaneous Dermatomyositis | Dermatomyositis | Drug: Baricitinib | University of Washington | NULL | Not yet recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 11 | ChiCTR2200059159 | 2022-04-26 | 2022-04-26 | Efficacy and safety of triple therapy based on prognostic risk stratification in patients with anti-MDA5 antibody-positive dermatomyositis: a multicenter, prospective, randomized controlled study | Efficacy and safety of triple therapy based on prognostic risk stratification in patients with anti-MDA5 antibody-positive dermatomyositis: a multicenter, prospective, randomized controlled study | anti-MDA5 antibody-positive dermatomyositis | experimental group:High-dose glucocorticoid + cyclophosphamide + calcineurin inhibitor;control group:High-dose glucocorticoid + cyclophosphamide or calcineurin inhibitor; | First Affiliated Hospital of Nanjing Medical University | NULL | Pending | 18 | 100 | Both | experimental group:60;control group:60; | Phase 4 | China |
| 12 | JPRN-jRCT2031210681 | 16/03/2022 | 18/03/2022 | Ravulizumab versus Placebo in Adult Participants with Dermatomyositis | A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis | Dermatomyositis | Eligible participants will be enrolled into the study and will be randomized in a 2:1 ratio (Part A) or a 1:1 ratio (Part B) to receive intravenous (IV) ravulizumab or placebo. The study intervention dose for each participant will be based on body weight. The dosing regimen for both Parts A and B consists of a loading dose followed by maintenance doses administered every 8 weeks (q8w). The maintenance dosing will be initiated 2 weeks after the loading dose is administered. The Randomized Controlled Period for Part A will be 26 weeks in duration. The Randomized Controlled Period for Part B will be 50 weeks in duration. Participants will receive ravulizumab during the OLE Period until ravulizumab is registered or approved (in accordance with country-specific regulations) or for up to 74 weeks (approximately 1.5 years), whichever occurs first. The total study treatment duration for Part A will be approximately 2 years and for Part B approximately 2.5 years. | Ishida Hirokazu | NULL | Recruiting | >= 18age old | Not applicable | Both | 180 | Phase 2-3 | USA;Italy;France;Germany;UK;Japan |
| 13 | EUCTR2021-004787-10-HU (EUCTR) | 07/03/2022 | 29/12/2021 | An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study | AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS =18 AND =80 WITH ACTIVE 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: PF-06823859 Product Code: PF-06823859 INN or Proposed INN: PF-06823859 Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;Hungary;Spain;Poland;Australia;Germany;Italy | ||
| 14 | NCT05239702 (ClinicalTrials.gov) | February 28, 2022 | 1/12/2021 | Clinical Study of Targeting CD7 CAR-T Cells in the Treatment of Autoimmune Diseases | A Clinical Study on the Safety and Effectiveness of Targeting CD7 Chimeric Antigen Receptor T Cells in the Treatment of Autoimmune Diseases | Crohn Disease;Ulcerative Colitis;Dermatomyositis;Still Disease;Autoimmune Diseases | Biological: CD7 CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 75 | Early Phase 1 | China |
| 15 | EUCTR2021-004787-10-PL (EUCTR) | 31/01/2022 | 05/01/2022 | An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study | AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS =18 AND =80 WITH ACTIVE 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: PF-06823859 Product Code: PF-06823859 INN or Proposed INN: PF-06823859 Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | United States;Hungary;Spain;Poland;Australia;Germany;Italy | ||
| 16 | NCT05375435 (ClinicalTrials.gov) | January 1, 2022 | 11/5/2022 | Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis | Efficacy and Safety of Triple Therapy Based on Prognostic Risk Stratification in Patients With Anti-MDA5 Antibody-positive Dermatomyositis: a Multicenter, Prospective, Randomized Controlled Study | Dermatomyositis, Adult Type;Interstitial Lung Disease | Drug: triple therapy;Drug: dual-therapy | The First Affiliated Hospital with Nanjing Medical University | NULL | Recruiting | 18 Years | N/A | All | 120 | Phase 4 | China |
| 17 | NCT05192200 (ClinicalTrials.gov) | December 20, 2021 | 1/12/2021 | An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study | AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO INVESTIGATE THE SAFETY OF PF-06823859 ADMINISTERED TO ADULT PARTICIPANTS =18 AND =80 WITH ACTIVE DERMATOMYOSITIS. | Dermatomyositis | Drug: Anti-Beta Interferon (PF-06823859) | Pfizer | NULL | Active, not recruiting | 18 Years | 80 Years | All | 24 | Phase 2 | United States;Hungary;Poland;Spain |
| 18 | NCT04976140 (ClinicalTrials.gov) | December 15, 2021 | 1/7/2021 | Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis | A Prospective, Open, Dose-escalation, Multi-center, Phase 1/2a Trial to Evaluate the Safety, Tolerability and to Explore the Efficacy of PN-101 in Patients With Refractory Polymyositis or Dermatomyositis | Polymyositis;Dermatomyositis | Biological: PN-101 | Paean Biotechnology Inc. | NULL | Enrolling by invitation | 19 Years | N/A | All | 18 | Phase 1/Phase 2 | Korea, Republic of |
| 19 | NCT04999020 (ClinicalTrials.gov) | December 2, 2021 | 4/8/2021 | Ravulizumab Versus Placebo in Adult Participants With Dermatomyositis | A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Dermatomyositis | Dermatomyositis | Drug: Ravulizumab;Drug: Placebo | Alexion Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 2/Phase 3 | United States;France;Germany;Italy;Japan;Korea, Republic of;Spain;United Kingdom |
| 20 | EUCTR2021-000898-83-IT (EUCTR) | 10/11/2021 | 07/10/2021 | Phase II placebo controlled study, to evaluate the efficacy and safety of begelomab in combination with standard immunosuppressive therapy and/or corticosteroids in the treatment of patients with dermatomyositis | A phase II, randomized, double-blind, placebo-controlled, two-period, crossover trial to assess the efficacy and safety of begelomab in combination with standard steroid and/or immunosuppressant therapy in the treatment of patients with dermatomyositis - ADN016 | 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: Begelomab Product Code: [Not applicable] | ADIENNE SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 21 | NCT04723303 (ClinicalTrials.gov) | October 6, 2021 | 8/12/2020 | Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM) | Phase 1 Study of Mesenchymal Stromal Cells, Umbilical Cord Lining Stem Cells (ULSC), in Patients With Polymyositis (PM) and Dermatomyositis (DM) | Polymyositis;Dermatomyositis | Drug: Umbilical Cord Lining Stem Cells | University of Florida | Restem, LLC. | Active, not recruiting | 18 Years | 90 Years | All | 10 | Early Phase 1 | United States |
| 22 | EUCTR2021-001200-15-DE (EUCTR) | 05/10/2021 | 15/06/2021 | Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. | A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis. - Ravulizumab versus Placebo in Adult Participants 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] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: ALXN1210 Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: ALXN1210 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | France;United States;Spain;Germany;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 23 | EUCTR2021-001200-15-ES (EUCTR) | 27/09/2021 | 16/09/2021 | Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. | A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis. - Ravulizumab versus Placebo in Adult Participants 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] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: ALXN1210 Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: ALXN1210 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | France;United States;Spain;Germany;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 24 | EUCTR2021-001200-15-IT (EUCTR) | 16/08/2021 | 18/10/2021 | Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. | A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis. - Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. | Dermatomyositis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: [ALXN1210] INN or Proposed INN: RAVULIZUMAB Other descriptive name: ALXN1210 Trade Name: Ultomiris Product Name: Ravulizumab Product Code: [ALXN1210] INN or Proposed INN: RAVULIZUMAB Other descriptive name: ALXN1210 Trade Name: Nimenrix Product Name: Nimenrix Product Code: [NA] INN or Proposed INN: tetanus protein Other descriptive name: tetanus protein INN or Proposed INN: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED WITH TETANUS TOXOID CARRIER PROTEIN Other descriptive name: NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED WITH TETANUS TOXOID CARRIER PROTEIN INN or Proposed INN: NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN Other descriptive name: NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETA | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | France;United States;Spain;Germany;United Kingdom;Japan;Italy;Korea, Republic of | ||
| 25 | NCT05000216 (ClinicalTrials.gov) | August 13, 2021 | 6/8/2021 | COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders | Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01) | Rheumatoid Arthritis (RA);Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis (MS);Systemic Sclerosis (SSc);Pediatric SLE;Juvenile Idiopathic Arthritis (JIA);Juvenile Dermatomyositis (JDM);Pediatric-Onset Multiple Sclerosis (POMS) | Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: Continue IS (MMF or MPA);Drug: Continue IS (MTX);Biological: Continue IS (B cell depletion therapy);Biological: Monovalent [B.1.351] CoV2 preS dTM-AS03;Drug: Withhold IS (MMF or MPA);Drug: Withhold IS (MTX);Drug: Withhold IS (B cell depletion therapy);Biological: Moderna mRNA-1273, Bivalent;Biological: BNT162b2, Bivalent | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Recruiting | 2 Years | N/A | All | 2340 | Phase 2 | United States |
| 26 | EUCTR2021-001200-15-FR (EUCTR) | 10/08/2021 | 28/06/2021 | Ravulizumab versus Placebo in Adult Participants with Dermatomyositis. | A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Dermatomyositis. - Ravulizumab versus Placebo in Adult Participants 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] | Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: ALXN1210 Trade Name: Ultomiris Product Name: Ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB Other descriptive name: ALXN1210 | Alexion Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2;Phase 3 | United States;France;Spain;Germany;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 27 | EUCTR2020-004228-41-DE (EUCTR) | 28/07/2021 | 17/02/2021 | A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with Dermatomyositis | A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS 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: PF-06823859 Product Code: PF-06823859 INN or Proposed INN: PF-06823859 Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 2 | United States;Hungary;Spain;Poland;Germany;Italy | ||
| 28 | EUCTR2020-004228-41-HU (EUCTR) | 07/07/2021 | 26/03/2021 | A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with Dermatomyositis | A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS 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: PF-06823859 Product Code: PF-06823859 INN or Proposed INN: PF-06823859 Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 2 | United States;Hungary;Spain;Poland;Germany;Italy | ||
| 29 | EUCTR2020-004228-41-IT (EUCTR) | 15/06/2021 | 07/06/2021 | A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with Dermatomyositis | A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS 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: PF-06823859 Product Code: [PF-06823859] Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta | PFIZER INC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 2 | United States;Hungary;Spain;Poland;Germany;Italy | ||
| 30 | EUCTR2020-004228-41-ES (EUCTR) | 28/05/2021 | 01/09/2021 | A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with Dermatomyositis | A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS 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: PF-06823859 Product Code: PF-06823859 INN or Proposed INN: PF-06823859 Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 2 | United States;Hungary;Poland;Spain;Germany;Italy | ||
| 31 | EUCTR2020-004228-41-PL (EUCTR) | 13/04/2021 | 08/03/2021 | A placebo-controlled study to evaluate the efficacy, safety and tolerability of PF-06823859 in adult subjects with Dermatomyositis | A PHASE 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PF-06823859 IN ADULT SUBJECTS 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: PF-06823859 Product Code: PF-06823859 INN or Proposed INN: PF-06823859 Other descriptive name: Humanised IgG1K monoclonal antibody against interferon beta | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 2 | United States;Hungary;Spain;Poland;Germany;Italy | ||
| 32 | EUCTR2019-002605-22-DE (EUCTR) | 11/03/2021 | 16/12/2019 | A study to evaluate the safety and efficacy of KZR-616 for the tretament of patients with active inflammations of the muscle and the skin (rheumatic disease) | A Phase 2 Randomized, Double-blind, Placebo-controlled,Crossover Multicenter Study to Evaluate the Safety and Efficacy ofKZR-616 in the Treatment of Patients with Active Polymyositis orDermatomyositis | Autoimmune Disorders Polymyositis and Dermatomyositis MedDRA version: 20.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KZR-616 INN or Proposed INN: KZR-616 Other descriptive name: KZR-616 maleate | Kezar Life Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Czechia;Czech Republic;Poland;Germany | ||
| 33 | NCT04946669 (ClinicalTrials.gov) | February 1, 2021 | 17/5/2021 | An Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory Dermatomyositis | An Exploratory Study on the Efficacy and Safety of Abatacept in the Treatment of Refractory Dermatomyositis | Dermatomyositis;Abatacept | Drug: Abatacept | The First Affiliated Hospital with Nanjing Medical University | National Natural Science Foundation of China | Recruiting | 18 Years | N/A | All | 20 | Early Phase 1 | China |
| 34 | ChiCTR2000036282 | 2020-12-01 | 2020-08-22 | A prospective, double-blind, positive control study of abatacept in the treatment of high-risk patients with dermatomyositis and rapidly progressing interstitial pneumonia | Study on Early Diagnosis and Treatment Strategy of Dermatomyositis Complicated with Rapidly Progressive Interstitial Pneumonia | dermatomyositis | Abatacept 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 Medicine | NULL | Pending | 18 | 70 | Both | Abatacept treatment group:20;Saline group:20; | China | |
| 35 | NCT04628936 (ClinicalTrials.gov) | November 4, 2020 | 2/11/2020 | Open-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 Dermatomyositis | Polymyositis;Dermatomyositis | Drug: KZR-616 | Kezar Life Sciences, Inc. | NULL | Enrolling by invitation | 18 Years | N/A | All | 24 | Phase 2 | United States |
| 36 | NCT04613219 (ClinicalTrials.gov) | October 1, 2020 | 15/9/2020 | Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease | Correlation Between the Change of Peripheral Lymphocyte Subsets and Clinically Amyopathic Dermatomyositis Combined With Rapidly Progressive Interstitial Lung Disease | Clinically Amyopathic Dermatomyisitis(CAMD) | Drug: Tofacitinib 5 MG [Xeljanz] | Jing Liang | NULL | Recruiting | 18 Years | 80 Years | All | 80 | China | |
| 37 | ChiCTR2000036709 | 2020-10-01 | 2020-08-24 | Study on early warning of rapid progressive interstitial lung disease in dermatomyositis | Study on early warning of rapid progressive interstitial lung disease in dermatomyositis | Dermatomyositis | Group 1:Glucocorticoid + cyclophosphamide + cyclosporin;Group 2:Glucocorticoid + cyclophosphamide + Tofacitinib; | Zhongshan Hospital of Fudan University | NULL | Pending | 18 | 60 | Both | Group 1:15;Group 2:15; | N/A | China |
| 38 | EUCTR2020-001762-11-GB (EUCTR) | 17/09/2020 | 23/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 39 | EUCTR2020-001762-11-HU (EUCTR) | 26/08/2020 | 02/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 40 | JPRN-jRCTs031200005 | 30/04/2020 | 10/04/2020 | Investigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositis | Investigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositis - ACDM | Dermatomyositis Collagen disease, inflammatory myopathy, cutaneous manifestation;D003882 | Oral administration of apremilast: Start with 10 mg of oral dose and gradually increase the dose until day 5, 30mg twice a day from day 6 (morning / evening) for a total of 12 weeks | Okiyama Naoko | NULL | Complete | >= 20age old | < 80age old | Both | 5 | Phase 1-2 | Japan |
| 41 | NCT04966884 (ClinicalTrials.gov) | April 2, 2020 | 15/7/2021 | The Efficacy and Safety of JAK Inhibitor in the Treatment of Anti-MDA5 Antibody-positive Dermatomyositis Patients | The Efficacy and Safety of JAK Inhibitor in the Treatment of Anti-MDA5 Antibody-positive Dermatomyositis Patients | Dermatomyositis, Adult Type | Drug: JAK Inhibitor | First Affiliated Hospital Xi'an Jiaotong University | NULL | Recruiting | 18 Years | 70 Years | All | 20 | Phase 4 | China |
| 42 | ChiCTR2000031286 | 2020-03-27 | 2020-03-26 | Establishment and validation of the risk prediction model of dermatomyositis combined with malignant tumor nomogram | Establishment and validation of the risk prediction model of dermatomyositis combined with malignant tumor nomogram | Dermatomyositic | Gold Standard:Clinical outcomes (whether combined with malignant tumor);Index test:The risk prediction model of dermatomyositis combined with malignant tumor nomogram; | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | NULL | Recruiting | 85 | 1 | Both | Target condition:240;Difficult condition:0 | China | |
| 43 | EUCTR2019-002605-22-CZ (EUCTR) | 28/01/2020 | 29/11/2019 | A study to evaluate the saftey and efficacy of KZR-616 for the tretament of patients with active inflammations of the muscle and the skin (rheumatic disease) | A Phase 2 Randomized, Double-blind, Placebo-controlled,Crossover Multicenter Study to Evaluate the Safety and Efficacy ofKZR-616 in the Treatment of Patients with Active Polymyositis orDermatomyositis | Autoimmune Disorders Polymyositis and Dermatomyositis MedDRA version: 20.0;Level: HLGT;Classification code 10003816;Term: Autoimmune disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KZR-616 INN or Proposed INN: KZR-616 Other descriptive name: KZR-616 maleate Product Name: KZR-616 INN or Proposed INN: KZR-616 Other descriptive name: KZR-616 maleate | Kezar Life Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | United States;Czechia;Hungary;Czech Republic;Poland;Germany | ||
| 44 | EUCTR2018-003171-35-DE (EUCTR) | 20/01/2020 | 18/09/2019 | 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) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan | ||
| 45 | NCT04033926 (ClinicalTrials.gov) | January 14, 2020 | 23/7/2019 | 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. | NULL | Completed | 18 Years | N/A | All | 25 | Phase 2 | United States;Czechia;Germany;Poland |
| 46 | NCT03582800 (ClinicalTrials.gov) | January 6, 2020 | 13/6/2018 | Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study | Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study | Systemic Sclerosis;Dermatomyositis;iPPSD2 | Drug: STS | University Hospital, Limoges | NULL | Recruiting | 6 Months | N/A | All | 40 | Phase 2 | France |
| 47 | ChiCTR1900028143 | 2020-01-01 | 2019-12-13 | Effect of Tacrolimus on dermatomyositis/polymyositis | A Single-center, randomized, controlled trial for Tacrolimus in patients with dermatomyositis/polymyositis | dermatomyositis/polymyositis | Control group:glucocorticoid ;Treatment group:Glucocorticoid+Tacrolimus;Control group:Glucocorticoid+Cyclophosphamide; | Department of Rheumatology and Immunology, Tianjin Medical University General Hospital | NULL | Pending | 18 | 70 | Both | Control group:20;Treatment group:20;Control group:20; | Phase 4 | China |
| 48 | EUCTR2018-003171-35-BE (EUCTR) | 21/11/2019 | 18/09/2019 | 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) – The RECLAIIM Study | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Argentina;Belgium;Australia;Germany;Japan | ||
| 49 | EUCTR2018-003171-35-ES (EUCTR) | 14/11/2019 | 29/11/2019 | 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 MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;France;European Union;Mexico;Canada;Argentina;Australia;Germany;Japan | ||
| 50 | EUCTR2018-003273-10-DE (EUCTR) | 06/11/2019 | 11/12/2018 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Russian Federation;United States;Greece;Austria;Netherlands;Sweden;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Serbia;Romania;Hungary;Japan;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Belgium;Italy;Israel;Australia;Germany | ||
| 51 | EUCTR2018-003171-35-IT (EUCTR) | 21/10/2019 | 22/01/2021 | 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) - NA | Dermatomyositis MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: [IgPro20] INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL BEHRING GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Phase 3 | United States;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Mexico;European Union;Canada;Argentina;Australia;Germany;Japan | ||
| 52 | NCT04044690 (ClinicalTrials.gov) | October 21, 2019 | 1/8/2019 | 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) - The RECLAIIM Study | Dermatomyositis | Drug: human immunoglobulin G;Drug: Placebo | CSL Behring | NULL | Recruiting | 18 Years | N/A | All | 126 | Phase 3 | United States;Belgium;Czechia;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Australia |
| 53 | EUCTR2018-003273-10-SE (EUCTR) | 30/09/2019 | 18/03/2019 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Russian Federation;United States;Greece;Sweden;Austria;Netherlands;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Serbia;Romania;Hungary;Japan;United Kingdom;Switzerland;Spain;Canada;Czech Republic;Belgium;Italy;Israel;Australia;Germany | ||
| 54 | EUCTR2018-003171-35-FR (EUCTR) | 24/09/2019 | 11/09/2019 | 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 MedDRA version: 20.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Hizentra Product Name: human immunoglobulin G Product Code: IgPro20 INN or Proposed INN: human immunoglobulin G Other descriptive name: Hizentra | CSL Behring LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 126 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Mexico;European Union;Canada;Argentina;Ukraine;Australia;Russian Federation;Japan;United Kingdom;Switzerland | ||
| 55 | ChiCTR1900025087 | 2019-09-01 | 2019-08-10 | Cyclosporine A in the treatment of polymyositis /dermatomyositis associated interstitial pulmonary disease: a prospective, opened, multicenter, randomized, controlled clinical study | Cyclosporine A in the Treatment of Polymyositis /Dermatomyositis With Interstitial Lung Disease (CTP /DMILD): a Prospective, Opened, Randomized, Multicenter, Controlled Trial | Polymyositis/Dermatomyositis associated Interstitial Lung Disease | treatment group:CsA+glucocorticoid;control group:CTX+glucocorticoid; | Guangdong Provincial People's Hospital | NULL | Pending | Both | treatment group:75;control group:75; | Phase 4 | China | ||
| 56 | JPRN-JapicCTI-194822 | 27/8/2019 | 25/06/2019 | 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 | PolymyositisDermatomyositis | Intervention 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. | NULL | complete | 18 | 75 | BOTH | 50 | Phase 3 | Japan |
| 57 | NCT02418273 (ClinicalTrials.gov) | August 1, 2019 | 6/4/2015 | 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 | NULL | Withdrawn | 4 Years | 16 Years | All | 0 | Phase 1/Phase 2 | United States |
| 58 | EUCTR2018-001978-22-FR (EUCTR) | 31/07/2019 | 17/09/2018 | Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study. | Injections of Sodium Thiosulfate for ectopic calcifications or ossifications. A pilot study. - ITS Pilot | Patient presenting with: - ectopic ossification secondary to iPPSD2 or - ectopic calcification secondary to dermatomyositis or - ectopic calcification secondary to systemic sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10006935;Term: Calcification and ossification, unspecified;System Organ Class: 100000004867 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Sodium Thiosulfate 10% Product Name: Sodium thiosulfate INN or Proposed INN: Sodium thiosulfate 10% Other descriptive name: SODIUM THIOSULFATE PENTAHYDRATE | CHU de LIMOGES | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France | ||
| 59 | EUCTR2018-003273-10-IT (EUCTR) | 11/07/2019 | 30/07/2021 | 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] INN or Proposed INN: Lenabasum Product Name: Lenabasum Product Code: [JBT-101] INN or Proposed INN: Lenabasum | CORBUS PHARMACEUTICALS, INC | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;United Kingdom;Italy;Switzerland;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of;Sweden | ||
| 60 | EUCTR2018-003273-10-CZ (EUCTR) | 27/05/2019 | 06/02/2019 | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United 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 | ||
| 61 | EUCTR2018-003273-10-GB (EUCTR) | 21/05/2019 | 20/11/2018 | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;United Kingdom;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 62 | EUCTR2018-003273-10-ES (EUCTR) | 16/05/2019 | 11/04/2019 | 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Spain;Switzerland;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden;Korea, Republic of | ||
| 63 | EUCTR2018-003273-10-BG (EUCTR) | 13/05/2019 | 18/03/2019 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Italy;United Kingdom;Czech Republic;Hungary;Canada;Poland;Bulgaria;Germany;Japan;Korea, Republic of;Sweden | ||
| 64 | EUCTR2018-003273-10-HU (EUCTR) | 05/04/2019 | 06/02/2019 | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Japan;Korea, Republic of;Sweden;United States;Serbia;Spain;United Kingdom;Switzerland;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria | ||
| 65 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Solid Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Hematopoietic and Lymphoid Cell Neoplasm;Inflammatory Bowel Disease;Metastatic Malignant Solid Neoplasm;Multiple Sclerosis;Psoriasis;Psoriatic Arthritis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Solid Neoplasm | Procedure: Biospecimen Collection;Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 1 | United States;Canada |
| 66 | NCT03817424 (ClinicalTrials.gov) | December 13, 2018 | 22/1/2019 | 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 | NULL | Completed | 18 Years | 75 Years | All | 31 | Phase 1 | United States;Poland;Spain |
| 67 | EUCTR2016-002269-77-IT (EUCTR) | 04/12/2018 | 22/01/2021 | A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle. | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) - A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatmen | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 21.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia Product Name: Orencia Product Code: [NA] INN or Proposed INN: ABATACEPT Other descriptive name: ABATACEPT | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Korea, Democratic People's Republic of;Italy;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Sweden | ||
| 68 | EUCTR2017-002710-31-DE (EUCTR) | 20/08/2018 | 24/05/2018 | 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% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Octapharma Pharmazeutika Produktionsges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Hungary;Czech Republic;Canada;Poland;Romania;Russian Federation;Netherlands;Germany | ||
| 69 | NCT03686969 (ClinicalTrials.gov) | August 2, 2018 | 31/8/2018 | 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 | NULL | Terminated | 18 Years | 80 Years | All | 1 | Phase 3 | Russian Federation;Czechia;Germany;Hungary;Poland;Romania |
| 70 | EUCTR2017-002710-31-RO (EUCTR) | 16/07/2018 | 25/05/2022 | 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% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Octapharma Pharmazeutika Produktionsges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Hungary;Czech Republic;Canada;Romania;Russian Federation;Germany | ||
| 71 | EUCTR2017-002710-31-HU (EUCTR) | 10/07/2018 | 19/07/2018 | 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% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Octapharma Pharmazeutika Produktionsges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Czech Republic;Hungary;Canada;Russian Federation;Germany | ||
| 72 | EUCTR2016-002902-37-NL (EUCTR) | 28/06/2018 | 24/01/2018 | 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% INN or Proposed INN: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Germany;Netherlands | ||
| 73 | EUCTR2017-002710-31-CZ (EUCTR) | 27/06/2018 | 01/06/2018 | 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% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Octapharma Pharmazeutika Produktionsges.m.b.H | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 3 | United States;Hungary;Czech Republic;Canada;Russian Federation;Germany | ||
| 74 | NCT03529955 (ClinicalTrials.gov) | June 12, 2018 | 24/4/2018 | 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 | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 2 | United States |
| 75 | NCT03857854 (ClinicalTrials.gov) | June 5, 2018 | 26/2/2019 | 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. | NULL | Recruiting | 18 Years | 65 Years | All | 152 | Phase 3 | China |
| 76 | EUCTR2018-000391-15-IT (EUCTR) | 05/06/2018 | 27/02/2018 | Multicentric, prospective open-label study to assess the efficacy and safety of Tocilizumab in subjects with refractory myositis | Multicentric, open-label, prospective study of subcutaneous tocilizumab in adult patients with refractory myositis - ToReMy | Myositis (dermatomyositis [DM] or polymyositis [PM]) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10028653;Term: Myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra 162 mg soluzione iniettabile in siringa preriempita Product Name: RoActemra 162 mg soluzione iniettabile in siringa preriempita Product Code: NA INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB | Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | Italy | ||
| 77 | JPRN-UMIN000032193 | 2018/04/11 | 13/04/2018 | 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 | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
| 78 | JPRN-UMIN000032022 | 2018/04/01 | 01/04/2018 | 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 | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 66 | Not selected | Japan |
| 79 | NCT03430388 (ClinicalTrials.gov) | January 31, 2018 | 30/1/2018 | 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 | NULL | Completed | 2 Years | 60 Years | All | 600 | N/A | Brazil |
| 80 | NCT03181893 (ClinicalTrials.gov) | January 23, 2018 | 5/6/2017 | A Study In Adults With Moderate To Severe Dermatomyositis | A PHASE 2 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 low;Drug: Placebo Arm;Drug: PF-06823859 high | Pfizer | NULL | Completed | 18 Years | 80 Years | All | 75 | Phase 2 | United States;Germany;Hungary;Poland;Spain;Australia;Italy |
| 81 | NCT03267277 (ClinicalTrials.gov) | October 5, 2017 | 29/8/2017 | 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 | Dermatomyositis;Idiopathic Inflammatory Myopathies | Drug: Sodium Thiosulfate | National Institute of Environmental Health Sciences (NIEHS) | NULL | Active, not recruiting | 7 Years | N/A | All | 14 | Phase 2/Phase 3 | United States |
| 82 | EUCTR2016-002269-77-FR (EUCTR) | 02/09/2017 | 11/02/2019 | 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) | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of | ||
| 83 | EUCTR2016-002269-77-DE (EUCTR) | 07/08/2017 | 28/04/2017 | A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle. | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of | ||
| 84 | EUCTR2016-002269-77-SE (EUCTR) | 04/08/2017 | 24/05/2017 | A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle. | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Korea, Republic of;Sweden | ||
| 85 | EUCTR2016-002269-77-CZ (EUCTR) | 20/07/2017 | 18/05/2017 | A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle. | A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults with Active Idiopathic Inflammatory Myopathy (IIM) | Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy) MedDRA version: 20.0;Level: LLT;Classification code 10042753;Term: Symptomatic inflammatory myopathy;System Organ Class: 100000018885;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;France;Hungary;Czech Republic;Mexico;Brazil;Australia;Germany;Japan;Italy;Sweden;Korea, Republic of | ||
| 86 | ChiCTR1800016629 | 2017-07-01 | 2018-06-14 | 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 | NULL | Recruiting | 18 | 80 | Both | study group:15;control group:35; | China | |
| 87 | NCT03192657 (ClinicalTrials.gov) | July 2017 | 15/6/2017 | 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 | NULL | Not yet recruiting | 18 Years | 65 Years | All | 100 | Phase 2 | China |
| 88 | JPRN-JapicCTI-173670 | 04/5/2017 | 09/08/2017 | 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 INN of the control intervention : - Dosage And administration of the control intervention : Placebo of Abatacept subcutaneous + Standard Treatment | Bristol-Myers Squibb K.K. | Ono Pharmaceutical Co., Ltd. | complete | 18 | BOTH | 150 | Phase 3 | Japan, Asia except Japan, North America, South America, Europe, Oceania | |
| 89 | NCT02980198 (ClinicalTrials.gov) | May 3, 2017 | 25/11/2016 | 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 | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2 | France;Germany;Italy;Switzerland;United Kingdom |
| 90 | EUCTR2015-003277-15-SE (EUCTR) | 12/04/2017 | 22/06/2016 | 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 INN or Proposed INN: IMO-8400 Product Name: IMO-8400 Product Code: IMO-8400 INN or Proposed INN: IMO-8400 | Idera Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Hungary;Czech Republic;United Kingdom;Sweden | ||
| 91 | NCT02728752 (ClinicalTrials.gov) | February 27, 2017 | 11/3/2016 | 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 | NULL | Completed | 18 Years | N/A | All | 95 | Phase 3 | United States;Canada;Czechia;Germany;Hungary;Netherlands;Poland;Romania;Russian Federation;Ukraine;Czech Republic;France |
| 92 | EUCTR2016-002902-37-DE (EUCTR) | 21/02/2017 | 29/09/2016 | 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% INN or Proposed INN: IMMUNOGLOBULIN G Trade Name: Isotone Kochsalz-Lösung 0,9 % Braun Infusionslösung Product Name: 0.9% w/v isotonic sodium chloride solution INN or Proposed INN: SODIUM CHLORIDE | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 3 | United States;France;Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Russian Federation;Netherlands;Germany | ||
| 93 | EUCTR2016-002902-37-HU (EUCTR) | 09/02/2017 | 19/12/2016 | 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: 19.0;Level: LLT;Classification code 10001403;Term: Adult dermatomyositis;System Organ Class: 100000004858;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G Trade Name: Octagam 10% INN or Proposed INN: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Phase 3 | France;United States;Czech Republic;Hungary;Canada;Poland;Russian Federation;Germany | ||
| 94 | NCT03002649 (ClinicalTrials.gov) | January 2017 | 20/12/2016 | 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 | Completed | 18 Years | N/A | All | 10 | Phase 1 | United States |
| 95 | NCT03092154 (ClinicalTrials.gov) | January 2017 | 9/3/2017 | 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 | NULL | Terminated | 18 Years | N/A | All | 24 | N/A | Brazil |
| 96 | EUCTR2016-002902-37-CZ (EUCTR) | 20/12/2016 | 26/09/2016 | 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% INN or Proposed INN: IMMUNOGLOBULIN G | Octapharma Pharmazeutika Produktionsges.m.b.H. | NULL | Not Recruiting | Female: yes Male: yes | 94 | Phase 3 | Canada;Czech Republic;Netherlands;Russian Federation;Romania;Hungary;United States;Ukraine;Poland;France;Germany | ||
| 97 | ChiCTR-DDD-16009687 | 2016-10-28 | 2016-10-28 | The precision diagnosis of dermatomyositis with malignant tumor or fatal interstitial lung disease | The precision diagnosis of dermatomyositis with malignant tumor or fatal interstitial lung disease | Dermatomyositis | Gold Standard:;Index test:; | Department of Dermatology, Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University | NULL | Recruiting | 18 | Both | Target condition:0;Difficult condition:0 | China | ||
| 98 | EUCTR2015-003277-15-GB (EUCTR) | 02/09/2016 | 31/12/2015 | 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 INN or Proposed INN: IMO-8400 Product Name: IMO-8400 Product Code: IMO-8400 INN or Proposed INN: IMO-8400 | Idera Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Czech Republic;United Kingdom;Sweden | ||
| 99 | NCT02780674 (ClinicalTrials.gov) | August 26, 2016 | 3/5/2016 | 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 | Viela Bio | MedImmune LLC | Completed | 18 Years | 65 Years | All | 36 | Phase 1 | United States |
| 100 | EUCTR2015-003277-15-HU (EUCTR) | 12/08/2016 | 20/06/2016 | 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 INN or Proposed INN: IMO-8400 | Idera Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Czech Republic;Hungary;United Kingdom;Sweden | ||
| 101 | NCT03027674 (ClinicalTrials.gov) | August 2016 | 13/1/2017 | 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 | NULL | Completed | 13 Years | 99 Years | All | 10 | Early Phase 1 | Chile |
| 102 | EUCTR2016-000137-52-DE (EUCTR) | 26/07/2016 | 06/06/2016 | 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 INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance | Neovacs SA | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Germany;Italy;United Kingdom;Switzerland | ||
| 103 | NCT02821689 (ClinicalTrials.gov) | July 2016 | 21/6/2016 | 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 | NULL | Not yet recruiting | 16 Years | N/A | Both | 57 | Phase 4 | China |
| 104 | NCT02612857 (ClinicalTrials.gov) | November 2015 | 18/11/2015 | 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. | NULL | Completed | 18 Years | 75 Years | All | 30 | Phase 2 | United States;Hungary;United Kingdom |
| 105 | NCT02594735 (ClinicalTrials.gov) | November 2015 | 21/10/2015 | Abatacept in Juvenile Dermatomyositis | Abatacept for the Treatment of Refractory Juvenile Dermatomyositis | Dermatomyositis | Drug: Abatacept | George Washington University | NULL | Completed | 7 Years | N/A | All | 10 | Phase 4 | United States |
| 106 | JPRN-UMIN000018376 | 2015/07/22 | 22/07/2015 | 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 | NULL | Complete: follow-up complete | 2years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 107 | NCT02245841 (ClinicalTrials.gov) | June 15, 2015 | 11/9/2014 | 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 | Completed | 18 Years | N/A | All | 15 | Phase 4 | United States |
| 108 | NCT02466243 (ClinicalTrials.gov) | June 2015 | 2/6/2015 | 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 | Terminated | 18 Years | 70 Years | All | 22 | Phase 2 | United States |
| 109 | NCT02267005 (ClinicalTrials.gov) | March 2015 | 1/10/2014 | 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 | NULL | Completed | 7 Years | 18 Years | All | 13 | N/A | Canada |
| 110 | EUCTR2012-005772-34-BE (EUCTR) | 03/12/2014 | 13/10/2014 | 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;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | 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 | |||
| 111 | EUCTR2012-005772-34-GR (EUCTR) | 11/11/2014 | 20/10/2014 | A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis 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 or dermatomyositis disease | Polymyositis / Dermatomyositis MedDRA version: 17.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 40 | Greece;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Brazil;Australia;Denmark;South Africa;Germany;Sweden | |||
| 112 | NCT02271165 (ClinicalTrials.gov) | November 2014 | 15/10/2014 | Subcutaneous Immunoglobulin (Hizentra) in Patients With Dermatomyositis: A Proof of Concept Study | Dermatomyositis | Drug: Immunoglobulin (Hizentra) | Thomas Jefferson University | NULL | Terminated | 18 Years | N/A | All | 2 | Early Phase 1 | United States | |
| 113 | JPRN-UMIN000015469 | 2014/10/20 | 18/10/2014 | 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 | NULL | Complete: follow-up complete | 18years-old | 75years-old | Male and Female | 50 | Not selected | Japan |
| 114 | EUCTR2012-002859-42-BE (EUCTR) | 16/10/2014 | 25/08/2014 | 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: 18.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BAF312 0.25 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimid Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: BAF312 2 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: BAF312 0,5 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium | ||
| 115 | EUCTR2013-001799-39-BE (EUCTR) | 16/10/2014 | 02/09/2014 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium;Germany;Japan | ||
| 116 | NCT02043548 (ClinicalTrials.gov) | October 1, 2014 | 17/1/2014 | 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. | Completed | 18 Years | N/A | All | 36 | Phase 2 | United States |
| 117 | ChiCTR-IPR-16007958 | 2014-06-01 | 2016-02-21 | 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 | NULL | Completed | Both | Rsearch group:30;Control group:30; | China | |||
| 118 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with 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 | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 119 | NCT02159651 (ClinicalTrials.gov) | April 1, 2014 | 6/6/2014 | 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 | NULL | Completed | N/A | N/A | All | 179 | Japan | |
| 120 | EUCTR2013-001799-39-PL (EUCTR) | 15/02/2014 | 13/01/2014 | 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. | Active dermatomyositis MedDRA version: 17.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BAF312 INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Hungary;Czech Republic;Canada;Poland;Germany;Japan | |||
| 121 | EUCTR2012-005772-34-GB (EUCTR) | 21/01/2014 | 10/06/2013 | A 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 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 or dermatomyositis or necrotizing autoimmune myopathy disease | Polymyositis / Dermatomyositis / Necrotizing autoimmune myopathy MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Servier Research and Development Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Hungary;Czech Republic;Greece;Belgium;Brazil;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | ||
| 122 | EUCTR2013-001799-39-CZ (EUCTR) | 19/12/2013 | 08/10/2013 | 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. | Active dermatomyositis MedDRA version: 18.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BAF312 0.25 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 0.5 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 1 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Code: BAF312 2 mg INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Hungary;Czech Republic;Canada;Poland;Germany;Japan | |||
| 123 | EUCTR2012-003633-42-GB (EUCTR) | 18/10/2013 | 22/08/2013 | A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases | A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD | A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Cyclophosphamide Injection 1g Product Name: Cyclophosphamide Injection 1g INN or Proposed INN: Cyclophosphamide | Royal Brompton and Harefield NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 124 | EUCTR2013-001799-39-HU (EUCTR) | 26/09/2013 | 08/08/2013 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Belgium;Netherlands;Germany;Japan;China;Switzerland | |||
| 125 | EUCTR2012-005772-34-DE (EUCTR) | 09/09/2013 | 04/06/2013 | 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;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Czech Republic;Belgium;Brazil;Spain;Denmark;Germany;Italy;United Kingdom;Sweden | |||
| 126 | EUCTR2012-005772-34-SE (EUCTR) | 04/09/2013 | 03/06/2013 | 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;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | 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 | |||
| 127 | NCT01906372 (ClinicalTrials.gov) | September 2013 | 5/7/2013 | 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 | Completed | 18 Years | N/A | All | 12 | Phase 2 | United States |
| 128 | NCT02029274 (ClinicalTrials.gov) | August 25, 2013 | 2/12/2013 | Safety and Efficacy of BAF312 in Dermatomyositis | A Double Blind, Randomized, Placebo-controlled Study to Evaluate, Safety, Tolerability, Efficacy and Preliminary Dose-response of BAF312 in Patients With Active Dermatomyositis (DM) | Active Dermatomyositis | Drug: BAF312;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 75 Years | All | 17 | Phase 2 | United States;Czechia;Japan;Belgium;Canada;China;Czech Republic;Hungary;Netherlands;Poland;Switzerland;Taiwan |
| 129 | EUCTR2012-005772-34-HU (EUCTR) | 11/07/2013 | 12/06/2013 | 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 myophaty 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 myophaty disease | Polymyositis / Dermatomyositis /necrotizing autoimmune myophaty MedDRA version: 17.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 17.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Czech Republic;Hungary;Belgium;Spain;Brazil;Denmark;Germany;United Kingdom;Italy;Sweden | |||
| 130 | EUCTR2012-005772-34-ES (EUCTR) | 24/06/2013 | 10/06/2013 | A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis 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 or dermatomyositis disease | Polymyositis / Dermatomyositis MedDRA version: 16.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 16.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Laboratorios Servier S.L | Institut de Recherches Internationales Servier (IRIS) | Not Recruiting | Female: yes Male: yes | 40 | Spain;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Brazil;Belgium;Denmark;Norway;Germany;Sweden | |||
| 131 | EUCTR2012-005772-34-IT (EUCTR) | 17/06/2013 | 22/05/2013 | A placebo-controlled, proof-of concept study of the efficacy of gevokizumab subcutaneously over 24 weeks in the treatment of patients with polymyositis or dermatomyositis 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 or dermatomyositis disease | Polymyositis / Dermatomyositis MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Greece;Spain;Italy;United Kingdom;France;Czech Republic;Hungary;Argentina;Brazil;Belgium;Denmark;Norway;Germany;Sweden | ||
| 132 | EUCTR2012-005772-34-CZ (EUCTR) | 06/06/2013 | 06/06/2013 | 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: 18.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 18.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Gevokizumab Product Code: S78989 INN or Proposed INN: gevokizumab Other descriptive name: XOMA 052 | Institut de Recherches Internationales Servier (IRIS) | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;Hungary;Czech Republic;Greece;Belgium;Spain;Brazil;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 133 | EUCTR2012-002859-42-PL (EUCTR) | 23/05/2013 | 04/02/2013 | Efficacy and tolerability for 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 MedDRA version: 19.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Siponimod 0.25 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 1 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 2 mg Tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate Product Name: Siponimod 0.5 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;Hungary;Czech Republic;Taiwan;Canada;Belgium;Poland;Switzerland | ||
| 134 | ChiCTR-TRC-13003178 | 2013-05-01 | 2013-01-03 | 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 | NULL | 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; | China | |
| 135 | NCT01801917 (ClinicalTrials.gov) | April 24, 2013 | 1/2/2013 | 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 | NULL | Terminated | 18 Years | 75 Years | All | 14 | Phase 2 | United States;Canada;Czechia;Hungary;Poland;Taiwan;Belgium;Czech Republic;Netherlands;Switzerland |
| 136 | NCT01637064 (ClinicalTrials.gov) | April 2013 | 6/7/2012 | Dermatomyositis and Polymyositis Registry | Acthar Dermatomyositis and Polymyositis Treatment | Dermatomyositis;Polymyositis | Drug: Acthar | Phoenix Neurological Associates, LTD | NULL | Enrolling by invitation | 18 Years | 85 Years | Both | 100 | N/A | United States |
| 137 | EUCTR2012-002859-42-CZ (EUCTR) | 20/02/2013 | 18/12/2012 | 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: 19.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: BAF312 0.25 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimid Other descriptive name: BAF312 hemifumarate Product Name: BAF312 1 mg tablet Product Code: BAF312X INN or Proposed INN: Siponimod Other descriptive name: BAF312 hemifumarate | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;Hungary;Czech Republic;Canada;Belgium;Poland | ||
| 138 | EUCTR2012-002859-42-HU (EUCTR) | 25/01/2013 | 05/11/2012 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United States;Czech Republic;Hungary;Canada;Belgium;Poland | ||
| 139 | NCT01724580 (ClinicalTrials.gov) | October 2012 | 5/11/2012 | 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 | NULL | No longer available | 6 Months | N/A | All | United States;United Kingdom | ||
| 140 | NCT01572844 (ClinicalTrials.gov) | August 2012 | 4/4/2012 | 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 | NULL | Completed | 18 Years | 65 Years | All | 3 | Phase 2 | United States |
| 141 | EUCTR2009-015957-20-GB (EUCTR) | 29/05/2012 | 20/04/2012 | A clinical trial to investigate treatment with the drug abatacept in patients with polymyositis and dermatomyositis. | Abatacept Treatment in Polymyositis and Dermatomyositis - Artemis UK | Polymyositis and dermatomyositis MedDRA version: 14.1;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Orencia Product Name: Orencia Product Code: EMEA/H/C/000701 INN or Proposed INN: Abatacept Other descriptive name: Orencia (trade name) | Karolinska University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | United Kingdom;Sweden | |||
| 142 | EUCTR2009-015957-20-CZ (EUCTR) | 27/01/2011 | 17/09/2010 | 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;Classification code 10012503;Term: Dermatomyositis | Trade Name: ORENCIA INN or Proposed INN: ABATACEPT | Karolinska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Czech Republic;United Kingdom;Sweden | ||
| 143 | NCT01315938 (ClinicalTrials.gov) | January 2011 | 15/3/2011 | Abatacept Treatment in Polymyositis and Dermatomyositis | Abatacept Treatment in Polymyositis and Dermatomyositis | Polymyositis;Dermatomyositis | Drug: Abatacept Active Treatment;Drug: Abatacept Delayed-Onset Treatment | Karolinska Institutet | Institute of Rheumatology, Prague;King's College Hospital NHS Trust | Completed | 18 Years | 80 Years | All | 20 | Phase 2 | Czechia;Sweden;Czech Republic |
| 144 | NCT01217320 (ClinicalTrials.gov) | January 2011 | 6/10/2010 | 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 | NULL | Recruiting | 6 Years | 18 Years | Both | 40 | N/A | Brazil |
| 145 | JPRN-UMIN000031931 | 2010/12/01 | 27/03/2018 | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis - 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 | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 10 | Phase 2 | Japan |
| 146 | NCT01813617 (ClinicalTrials.gov) | September 2010 | 13/3/2013 | 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 | NULL | Completed | 18 Years | N/A | Both | 72 | N/A | Sweden |
| 147 | NCT01148810 (ClinicalTrials.gov) | June 15, 2010 | 21/6/2010 | Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis | 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;Dermatomyositis | Drug: BAF312;Drug: Placebo | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 75 Years | All | 18 | Phase 2 | United States;Czechia;Hungary;Sweden;United Kingdom;Czech Republic;Poland |
| 148 | NCT01151644 (ClinicalTrials.gov) | April 2010 | 25/6/2010 | 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 | Active, not recruiting | N/A | N/A | Both | 5000 | Phase 4 | Brazil |
| 149 | EUCTR2005-002463-88-HU (EUCTR) | 11/03/2010 | 01/10/2009 | 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 strenght under conventional therapy(Glucocorticosteroids associated with immunosuppresors) | Trade Name: Ig Vena Product Name: Ig VENA (10g/200mL) Product Code: L0133 | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria | |||
| 150 | EUCTR2009-015957-20-SE (EUCTR) | 16/02/2010 | 07/01/2010 | 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;Classification code 10012503;Term: Dermatomyositis | Trade Name: ORENCIA INN or Proposed INN: ABATACEPT | Karolinska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | United Kingdom;Sweden | |||
| 151 | NCT01140503 (ClinicalTrials.gov) | February 2010 | 6/4/2010 | 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 | NULL | Terminated | 18 Years | N/A | All | 5 | N/A | United States |
| 152 | EUCTR2005-002463-88-CZ (EUCTR) | 16/12/2009 | 05/10/2009 | 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 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) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Germany;Czech Republic;Italy;Austria | |||
| 153 | EUCTR2008-006311-21-CZ (EUCTR) | 19/11/2009 | 15/09/2009 | 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;Classification code 10012503;Term: Dermatomyositis | Product Name: BAF312 5 mg tablet Product Code: BAF312 Product Name: BAF312 4mg tablet Product Code: BAF312 Product Name: BAF312 1mg tablet Product Code: BAF312 Product Name: BAF312 0.25mg tablet Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Hungary;United Kingdom;Czech Republic;Sweden | ||||
| 154 | EUCTR2008-006311-21-SE (EUCTR) | 28/10/2009 | 24/07/2009 | Study to test the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositis | 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: 14.0;Level: PT;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.0;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders | Product Name: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Czech Republic;Hungary;United Kingdom;Sweden | |||
| 155 | EUCTR2008-006311-21-HU (EUCTR) | 16/10/2009 | 28/07/2009 | 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;Classification code 10012503;Term: Dermatomyositis | Product Name: BAF312 Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Hungary;Czech Republic;United Kingdom;Sweden | ||||
| 156 | EUCTR2008-006311-21-GB (EUCTR) | 28/07/2009 | 26/06/2009 | 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 | 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;Classification code 10012503;Term: Dermatomyositis | Product Name: BAF312 5 mg tablet Product Code: BAF312 Product Name: BAF312 4mg tablet Product Code: BAF312 Product Name: BAF312 1 mg tablet Product Code: BAF312 Product Name: BAF312 0.25 mg tablet Product Code: BAF312 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Hungary;United Kingdom;Sweden | ||
| 157 | JPRN-UMIN000001866 | 2009/04/01 | 10/04/2009 | 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 | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 158 | EUCTR2008-008169-36-NL (EUCTR) | 17/02/2009 | 29/12/2008 | Immune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV study | Immune response after Human Papillomavirus vaccination in patients with auto-immune disease - HPV study | Juvenile Idiopathic ArthritisSystemic lupus erythematosus childhood dermatomyositis MedDRA version: 9.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd MedDRA version: 9.1;Classification code 10059176;Term: Juvenile idiopathic arthritis MedDRA version: 9.1;Classification code 10008521;Term: Childhood dermatomyositis | Trade Name: Cervarix suspensie voor injectie Product Name: not applicable Product Code: not applicable | University Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: no | Netherlands | ||||
| 159 | EUCTR2006-000078-65-GB (EUCTR) | 08/12/2008 | 07/12/2010 | 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 | Karolinska University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 202 | Phase 2 | Czech Republic;United Kingdom;Sweden | ||
| 160 | EUCTR2008-001282-28-NL (EUCTR) | 23/09/2008 | 29/08/2008 | 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 INN or Proposed INN: Influvac Trade Name: Pneumovax 23 INN or Proposed INN: Pneumovax 23 Trade Name: HBvaxpro INN or Proposed INN: HBVAXPRO | Radboud University Nijmegen Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 161 | EUCTR2007-004410-13-SE (EUCTR) | 06/08/2008 | 18/06/2008 | 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;Classification code 10036102;Term: Polymyositis | Trade Name: Methotrexate Wyeth 2,5mg Product Name: Methotrexate Wyeth 2,5mg tbl. INN or Proposed INN: metotrexat Trade Name: Prednisolon Pfizer Product Name: prednisolon INN or Proposed INN: prednisolon Trade Name: Metoject 10 mg/ml Product Name: metotrexat INN or Proposed INN: metotrexat | Institute od Rheumatology Prague | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Czech Republic;Sweden | |||
| 162 | EUCTR2005-003956-37-GB (EUCTR) | 18/06/2008 | 20/03/2008 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Trade Name: treatment defined only by active substance Product Name: prednisone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not availa | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 163 | NCT00651040 (ClinicalTrials.gov) | May 2008 | 31/3/2008 | 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 | Completed | 18 Years | 80 Years | All | 31 | Phase 3 | Czech Republic |
| 164 | NCT00533091 (ClinicalTrials.gov) | April 2008 | 20/9/2007 | 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 | NULL | Completed | 18 Years | N/A | Both | 51 | Phase 1 | United States |
| 165 | EUCTR2007-004410-13-CZ (EUCTR) | 12/03/2008 | 25/10/2007 | 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;Classification code 10036102;Term: Polymyositis | Trade Name: Methotrexat Lachema 2,5mg Product Name: Methotrexat Lachema 2,5mg tbl. Product Code: 44/154/85-C INN or Proposed INN: METHOTREXATE Other descriptive name: methotrexate Trade Name: Prednison 5, 20 Léciva por. tablet nob. Product Name: Prednison 5, 20 Léciva por. tablet nob. Product Code: 56/104/75-C INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob Trade Name: Methotrexat Lachema 5 inj. sol Product Name: Methotrexate Lachema 5inj. sol Product Code: 44/196/81-C INN or Proposed INN: methotrexate Trade Name: Solu-medrol inj. PSO LQF 40mg Product Name: Solu-medrol inj. PSO lqf 40mg INN or Proposed INN: methylprednisoloni natrii succinas | Institute od Rheumatology Prague | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Czech Republic;Sweden | |||
| 166 | EUCTR2006-000078-65-CZ (EUCTR) | 12/11/2007 | 18/10/2007 | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM) | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM) | Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis. MedDRA version: 9.1;Level: LLT;Classification code 10036102;Term: Polymyositis | Trade Name: Mabthera Product Code: Mabthera | Karolinska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 202 | United Kingdom;Czech Republic;Sweden | |||
| 167 | JPRN-JMA-IIA00012 | 20/07/2007 | 05/07/2007 | 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 | Completed | >=16 YEARS | <75 YEARS | BOTH | 20 | Phase 2-3 | Japan |
| 168 | NCT00504348 (ClinicalTrials.gov) | July 2007 | 19/7/2007 | 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 | Completed | 16 Years | 74 Years | All | 25 | Phase 2/Phase 3 | Japan |
| 169 | EUCTR2005-003956-37-SE (EUCTR) | 23/02/2007 | 11/12/2006 | 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 | 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 at onset | Trade Name: treatment defined only by active substance Product Name: Prednisone Product Code: Not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: not available Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Methotrexate Product Code: not available | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 170 | EUCTR2006-000078-65-SE (EUCTR) | 17/01/2007 | 02/11/2006 | 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 INN or Proposed INN: Rituximab | Karolinska University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 202 | United Kingdom;Czech Republic;Sweden | |||
| 171 | EUCTR2005-003956-37-BE (EUCTR) | 13/11/2006 | 25/10/2006 | 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 - PRINTO JDM Trial | 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 - PRINTO JDM Trial | Juvenile Dermatomyositis at onset | Product Name: Prednisolone INN or Proposed INN: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone sodium succinate Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Methotrexate INN or Proposed INN: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate | University Hospital Gent | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 172 | EUCTR2005-003956-37-DK (EUCTR) | 03/11/2006 | 15/09/2006 | 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 | 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 at onset | Product Name: Prednisone Product Name: methylprednisolone Product Name: Cyclosporine Product Name: Cyclosporine Product Name: Cyclosporine Product Name: Metotrexate Product Name: Methotrexate | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Belgium;Denmark;Netherlands;United Kingdom;Italy;Sweden | ||
| 173 | EUCTR2005-003956-37-NL (EUCTR) | 26/09/2006 | 01/06/2006 | 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 | INN or Proposed INN: Prednisone INN or Proposed INN: Methylprednisolone INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 174 | EUCTR2005-002463-88-IT (EUCTR) | 17/08/2006 | 21/04/2006 | fficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM) | Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study. | Idiopathic dermatomyositis and polymyositis with insufficiently improved muscle strength under conventional therapy (glucocorticosteroids associated with immunosuppressors). MedDRA version: 14.1;Level: HLT;Classification code 10003821;Term: Muscular autoimmune disorders;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: IGVENA*FL 200ML 10G+SET | ORFAGEN | NULL | Not Recruiting | Female: yes Male: yes | 44 | Czech Republic;Hungary;Austria;Germany;Italy | |||
| 175 | EUCTR2005-002463-88-DE (EUCTR) | 18/07/2006 | 28/12/2005 | 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 Other descriptive name: Human normal immunoglobulin (IVIg) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria | |||
| 176 | NCT00335985 (ClinicalTrials.gov) | June 2006 | 8/6/2006 | 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 | NULL | Completed | 16 Years | 75 Years | Both | 26 | Phase 3 | Japan |
| 177 | EUCTR2005-003956-37-IT (EUCTR) | 02/05/2006 | 12/09/2006 | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND | New Onset juvenile dermatomyositis MedDRA version: 6.1;Level: PT;Classification code 10012503 | INN or Proposed INN: Prednisone INN or Proposed INN: Methylprednisolone INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate | ISTITUTO GIANNINA GASLINI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 178 | NCT00323960 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | 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 |
| 179 | EUCTR2005-003129-23-GB (EUCTR) | 18/04/2006 | 24/02/2006 | To prevent and treat osteoporosis in children with rhuematic diseases taking steroids | Prevention and Treatment of Steroid-Induced Osteopenia in children and adolescents with rheumatic diseases - POPS | Children and adolescents with Juvenile Idiopathic arthritis (JIA), Juvenile dermatomyositis (JDMS) Juvenile systemic lupus erythematosis (JSLE) Vasculitis;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Risedronate Sodium Product Code: 35mg Other descriptive name: RISEDRONATE SODIUM Product Name: Risedronate Sodium Product Code: 5mg Other descriptive name: RISEDRONATE SODIUM Trade Name: One-Alpha drops Product Name: One Alpha Drops Product Code: alfacalcidol 2 micrograms/ml INN or Proposed INN: ALFACALCIDOL Other descriptive name: drops | Belfast Health and Social Care Trust, Musgrave Park Hospital | NULL | Not Recruiting | Female: yes Male: yes | 216 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 180 | NCT00106184 (ClinicalTrials.gov) | March 2006 | 21/3/2005 | 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 | Completed | 5 Years | N/A | All | 200 | Phase 2 | United States;Canada;Czech Republic;Sweden;United Kingdom |
| 181 | NCT00112385 (ClinicalTrials.gov) | March 2006 | 2/6/2005 | 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 | Completed | 18 Years | 65 Years | All | 16 | Phase 1 | United States |
| 182 | EUCTR2005-002463-88-AT (EUCTR) | 02/02/2006 | 17/01/2006 | 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 Other descriptive name: Human normal immunoglobulin (IVIg) | Orfagen | NULL | Not Recruiting | Female: yes Male: yes | 44 | Hungary;Czech Republic;Germany;Italy;Austria | |||
| 183 | NCT01165008 (ClinicalTrials.gov) | September 2003 | 16/7/2010 | Anakinra in Myositis | Anakinra in Patients With Refractory Idiopathic Inflammatory Myopathies | Polymyositis;Dermatomyositis;Inclusion Body Myositis | Drug: Anakinra | Karolinska Institutet | NULL | Completed | 18 Years | 80 Years | Both | Phase 2/Phase 3 | Sweden | |
| 184 | NCT00035958 (ClinicalTrials.gov) | August 2002 | 7/5/2002 | 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 | Terminated | 4 Years | 16 Years | Both | 75 | Phase 2/Phase 3 | United States |
| 185 | NCT00033891 (ClinicalTrials.gov) | April 10, 2002 | 11/4/2002 | 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) | NULL | Completed | 18 Years | N/A | All | 14 | Phase 2 | United States |
| 186 | NCT00138983 (ClinicalTrials.gov) | May 2000 | 29/8/2005 | 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 | Completed | 18 Years | 90 Years | Both | 200 | Phase 3 | Netherlands |
| 187 | NCT00005571 (ClinicalTrials.gov) | April 2000 | 25/4/2000 | 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) | NULL | Completed | N/A | N/A | Both | 17 | Phase 2 | United States |
| 188 | NCT00004357 (ClinicalTrials.gov) | September 1997 | 18/10/1999 | 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 | Completed | 4 Years | 21 Years | Both | 6 | Phase 2 | United States |
| 189 | NCT00001421 (ClinicalTrials.gov) | June 1995 | 3/11/1999 | 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) | NULL | Completed | N/A | N/A | Both | 20 | Phase 2 | United States |
| 190 | NCT00001261 (ClinicalTrials.gov) | May 1990 | 3/11/1999 | 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) | NULL | Completed | N/A | N/A | Both | 120 | Phase 2 | United States |
| 191 | EUCTR2020-001762-11-AT (EUCTR) | 10/08/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 192 | EUCTR2020-001762-11-DE (EUCTR) | 17/09/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | |||
| 193 | EUCTR2020-001762-11-SE (EUCTR) | 17/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 194 | EUCTR2015-003424-31-GB (EUCTR) | 07/12/2015 | 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 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB INN or Proposed INN: baricitinib Other descriptive name: BARICITINIB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 60 | Phase 2 | France;United States;United Kingdom |