BAF312 0.25 mg tablet ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
50皮膚筋炎/多発性筋炎4

50. 皮膚筋炎/多発性筋炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2012-002859-42-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
2EUCTR2012-002859-42-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
3EUCTR2012-002859-42-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
4EUCTR2008-006311-21-GB
(EUCTR)
28/07/200926/06/2009A multi-centre, double-blind, placebo controlled, proof of concept study to evaluate the efficacy and tolerability of BAF312 in patients with polymyositis and dermatomyositisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Czech Republic;Hungary;United Kingdom;Sweden