50. 皮膚筋炎／多発性筋炎 Dermatomyositis Clinical trials / Disease details
臨床試験数 : 182 / 薬物数 : 229 - (DrugBank : 88) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 147
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | |||
| 4 | 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 | |||
| 5 | 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 | |||
| 6 | 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 |
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 |
| 12 | 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 | ||||
| 13 | 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 | |||
| 14 | 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 | ||||
| 15 | 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 |