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

  
8 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1EUCTR2013-001799-39-BE
(EUCTR)
16/10/201402/09/2014Study 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 AGNULLNot RecruitingFemale: yes
Male: yes
56Phase 2United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium;Germany;Japan
2EUCTR2012-002859-42-BE
(EUCTR)
16/10/201425/08/2014Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2United States;Hungary;Czech Republic;Taiwan;Canada;Poland;Belgium
3EUCTR2013-001799-39-PL
(EUCTR)
15/02/201413/01/2014Study 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 AGNULLNot RecruitingFemale: yes
Male: yes
56United States;Hungary;Czech Republic;Canada;Poland;Germany;Japan
4EUCTR2013-001799-39-CZ
(EUCTR)
19/12/201308/10/2013Study 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 AGNULLNot RecruitingFemale: yes
Male: yes
56United States;Hungary;Czech Republic;Canada;Poland;Germany;Japan
5EUCTR2013-001799-39-HU
(EUCTR)
26/09/201308/08/2013Study 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 AGNULLNot RecruitingFemale: yes
Male: yes
56United States;Czech Republic;Taiwan;Hungary;Canada;Poland;Belgium;Netherlands;Germany;Japan;China;Switzerland
6EUCTR2012-002859-42-PL
(EUCTR)
23/05/201304/02/2013Efficacy and tolerability for BAF312 in patients with polymyositisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2United States;Hungary;Czech Republic;Taiwan;Canada;Belgium;Poland;Switzerland
7EUCTR2012-002859-42-CZ
(EUCTR)
20/02/201318/12/2012Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2United States;Hungary;Czech Republic;Canada;Belgium;Poland
8EUCTR2012-002859-42-HU
(EUCTR)
25/01/201305/11/2012Study of efficacy and tolerability for BAF312 compared to placebo in patients with polymyositisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Czech Republic;Hungary;Canada;Belgium;Poland