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 | 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 | ||
| 3 | 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 | ||
| 4 | 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 |