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	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	NCT02306629 (ClinicalTrials.gov)	November 2014	29/11/2014	Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood	An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects	Systemic Lupus Erythematosus	Biological: Epratuzumab sc;Biological: Epratuzumab iv	UCB Biopharma S.P.R.L.	Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors Laboratory	Completed	18 Years	50 Years	Both	42	Phase 1	United Kingdom
2	EUCTR2009-017273-38-ES (EUCTR)	26/10/2010	27/07/2010	Estudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-V	Estudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-V	Nefritis lúpico tipo III,IV y V. MedDRA version: 9;Level: LLT;Classification code 10029142;Term: Nephritis systemic lupus erythematosus	Product Name: Ciclosporina Product Code: Csa INN or Proposed INN: CICLOSPORINA Other descriptive name: CICLOSPORIN INN or Proposed INN: PREDNISONA Other descriptive name: PREDNISONE Product Name: Acido Micofenolico Product Code: ACM INN or Proposed INN: MICOFENOLICO ACIDO Other descriptive name: MYCOPHENOLIC ACID	Manuel Praga Terente	NULL	Not Recruiting			Female: yes Male: yes	38		Spain

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

NCT02306629
(ClinicalTrials.gov)

November 2014

29/11/2014

Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood

An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects

Systemic Lupus Erythematosus

Biological: Epratuzumab sc;Biological: Epratuzumab iv

UCB Biopharma S.P.R.L.

Pharmaceutical Research Associates;Richmond Pharmacology Limited;ACM Global Europe;Eurofins Pharma Bioanalysis;The Doctors Laboratory

Completed

18 Years

50 Years

Both

Phase 1

United Kingdom

EUCTR2009-017273-38-ES
(EUCTR)

26/10/2010

27/07/2010

Estudio fase III, multicéntrico, aleatorizado, abierto de grupos paralelos para comparar la eficacia y seguridad de la pauta Prednisona-Ac Micofenólico-Ciclosporina a Prednisona-Ac Micofenólico en el tratamiento de las nefropatias lúpicas tipo III-IV-V

Nefritis lúpico tipo III,IV y V.
MedDRA version: 9;Level: LLT;Classification code 10029142;Term: Nephritis systemic lupus erythematosus

Product Name: Ciclosporina
Product Code: Csa
INN or Proposed INN: CICLOSPORINA
Other descriptive name: CICLOSPORIN
INN or Proposed INN: PREDNISONA
Other descriptive name: PREDNISONE
Product Name: Acido Micofenolico
Product Code: ACM
INN or Proposed INN: MICOFENOLICO ACIDO
Other descriptive name: MYCOPHENOLIC ACID

Manuel Praga Terente

NULL

Not Recruiting

Female: yes
Male: yes

Spain