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
13	多発性硬化症／視神経脊髄炎	0
46	悪性関節リウマチ	2
49	全身性エリテマトーデス	0

告示番号

疾患名（ページ内リンク）

臨床試験数

多発性硬化症／視神経脊髄炎

悪性関節リウマチ

全身性エリテマトーデス

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	NCT00779220 (ClinicalTrials.gov)	October 2008	23/10/2008	A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis	A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy	Rheumatoid Arthritis	Drug: placebo;Drug: methotrexate;Drug: ocrelizumabu 50mg;Drug: ocrelizumabu 200mg;Drug: ocrelizumab 500mg	Chugai Pharmaceutical	NULL	Terminated	20 Years	N/A	Both	152	Phase 2	Japan
2	JPRN-JapicCTI-070479		26/11/2007	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.	A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.	Rheumatoid arthritis	Intervention name : Ocrelizumab Dosage And administration of the intervention : Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26.	Chugai Pharmaceutical Co., Ltd.	NULL		20		BOTH		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

NCT00779220
(ClinicalTrials.gov)

October 2008

23/10/2008

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

Rheumatoid Arthritis

Drug: placebo;Drug: methotrexate;Drug: ocrelizumabu 50mg;Drug: ocrelizumabu 200mg;Drug: ocrelizumab 500mg

Chugai Pharmaceutical

NULL

Terminated

20 Years

N/A

Both

152

Phase 2

Japan

JPRN-JapicCTI-070479

26/11/2007

A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.

Rheumatoid arthritis

Intervention name : Ocrelizumab
Dosage And administration of the intervention : Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26.

Chugai Pharmaceutical Co., Ltd.

NULL

BOTH

Phase 3

NULL