DDrare: Database of Drug Development for Rare Diseases

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	2

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	NCT02971683 (ClinicalTrials.gov)	March 13, 2017	21/11/2016	Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy	A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)	Polymyositis;Dermatomyositis;Autoimmune Necrotizing Myopathy;Overlap Myositis;Juvenile Myositis Above the Age of 18	Drug: Abatacept subcutaneous;Drug: Placebo	Bristol-Myers Squibb	NULL	Active, not recruiting	18 Years	N/A	All	150	Phase 3	United States;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Sweden;Hungary
2	JPRN-JapicCTI-173670	01/3/2017	09/08/2017	Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy	A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)	Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18	Intervention name : Abatacept INN of the intervention : Abatacept Dosage And administration of the intervention : Abatacept subcutaneous + Standard Treatment Control intervention name : Placebo Dosage And administration of the control intervention : Placebo of Abatacept subcutaneous + Standard Treatment	Bristol-Myers Squibb K.K.	NULL	recruiting	18		BOTH	150	Phase 3	NULL

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

NCT02971683
(ClinicalTrials.gov)

March 13, 2017

21/11/2016

Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy

A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)

Polymyositis;Dermatomyositis;Autoimmune Necrotizing Myopathy;Overlap Myositis;Juvenile Myositis Above the Age of 18

Drug: Abatacept subcutaneous;Drug: Placebo

Bristol-Myers Squibb

NULL

Active, not recruiting

18 Years

N/A

All

150

Phase 3

United States;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Sweden;Hungary

JPRN-JapicCTI-173670

01/3/2017

09/08/2017

Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18

Intervention name : Abatacept
INN of the intervention : Abatacept
Dosage And administration of the intervention : Abatacept subcutaneous + Standard Treatment
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo of Abatacept subcutaneous + Standard Treatment

Bristol-Myers Squibb K.K.

NULL

recruiting

BOTH

150

Phase 3

NULL