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 | 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-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 | |||
| 3 | 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 | |||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 |