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
49	全身性エリテマトーデス	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	EUCTR2010-023645-29-DE (EUCTR)	15/03/2011	11/01/2011	Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE	Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE	Adult subjects of any ethnicity and either gender with Cutaneous Lupus Erythematosus lesions of Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of fumaric acid esters in the treatment of Cutaneous Lupus Erythematosus lesions. MedDRA version: 12.1;Level: LLT;Classification code 10056509;Term: Cutaneous lupus erythematosus MedDRA version: 12.1;Level: PT;Term: Cutaneous lupus erythematosus	Trade Name: Fumaderm® initial Product Name: - Product Code: - INN or Proposed INN: Dimethylfumarat INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz Trade Name: Fumaderm® Product Name: - Product Code: - INN or Proposed INN: Dimethylfumarat INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz	Universitätsklinikum Münster	NULL	Not Recruiting			Female: yes Male: yes	11		Germany

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

EUCTR2010-023645-29-DE
(EUCTR)

15/03/2011

11/01/2011

Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE

Adult subjects of any ethnicity and either gender with Cutaneous Lupus Erythematosus lesions of Subacute Cutaneous Lupus Erythematosus (SCLE), Discoid Lupus Erythematosus (DLE), Lupus erythematosus tumidus (LET) or Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions and without major organ involvement to investigate the efficacy of fumaric acid esters in the treatment of Cutaneous Lupus Erythematosus lesions.
MedDRA version: 12.1;Level: LLT;Classification code 10056509;Term: Cutaneous lupus erythematosus
MedDRA version: 12.1;Level: PT;Term: Cutaneous lupus erythematosus

Trade Name: Fumaderm® initial
Product Name: -
Product Code: -
INN or Proposed INN: Dimethylfumarat
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz
Trade Name: Fumaderm®
Product Name: -
Product Code: -
INN or Proposed INN: Dimethylfumarat
INN or Proposed INN: Ethylhydrogenfumarat, Calciumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Magnesiumsalz
INN or Proposed INN: Ethylhydrogenfumarat, Zinksalz

Universitätsklinikum Münster

NULL

Not Recruiting

Female: yes
Male: yes

Germany