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	1

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	EUCTR2007-004410-13-CZ (EUCTR)	12/03/2008	25/10/2007	A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS	A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS	active polymyositis, dermatomyositis MedDRA version: 9.1;Level: LLT;Classification code 10012503;Term: Dermatomyositis MedDRA version: 9.1;Classification code 10036102;Term: Polymyositis	Trade Name: Methotrexat Lachema 2,5mg Product Name: Methotrexat Lachema 2,5mg tbl. Product Code: 44/154/85-C INN or Proposed INN: METHOTREXATE Other descriptive name: methotrexate Trade Name: Prednison 5, 20 Léciva por. tablet nob. Product Name: Prednison 5, 20 Léciva por. tablet nob. Product Code: 56/104/75-C INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob Trade Name: Methotrexat Lachema 5 inj. sol Product Name: Methotrexate Lachema 5inj. sol Product Code: 44/196/81-C INN or Proposed INN: methotrexate Trade Name: Solu-medrol inj. PSO LQF 40mg Product Name: Solu-medrol inj. PSO lqf 40mg INN or Proposed INN: methylprednisoloni natrii succinas	Institute od Rheumatology Prague	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		Czech Republic;Sweden

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

EUCTR2007-004410-13-CZ
(EUCTR)

12/03/2008

25/10/2007

A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS

active polymyositis, dermatomyositis
MedDRA version: 9.1;Level: LLT;Classification code 10012503;Term: Dermatomyositis
MedDRA version: 9.1;Classification code 10036102;Term: Polymyositis

Trade Name: Methotrexat Lachema 2,5mg
Product Name: Methotrexat Lachema 2,5mg tbl.
Product Code: 44/154/85-C
INN or Proposed INN: METHOTREXATE
Other descriptive name: methotrexate
Trade Name: Prednison 5, 20 Léciva por. tablet nob.
Product Name: Prednison 5, 20 Léciva por. tablet nob.
Product Code: 56/104/75-C
INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob
Trade Name: Methotrexat Lachema 5 inj. sol
Product Name: Methotrexate Lachema 5inj. sol
Product Code: 44/196/81-C
INN or Proposed INN: methotrexate
Trade Name: Solu-medrol inj. PSO LQF 40mg
Product Name: Solu-medrol inj. PSO lqf 40mg
INN or Proposed INN: methylprednisoloni natrii succinas

Institute od Rheumatology Prague

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Czech Republic;Sweden