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
46	悪性関節リウマチ	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	NCT01001832 (ClinicalTrials.gov)	December 2009	26/10/2009	Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients	A Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: Intravenous (IV) abatacept;Drug: Subcutaneous (SC) abatacept	Bristol-Myers Squibb	NULL	Completed	20 Years	N/A	All	118	Phase 2;Phase 3	Japan
2	NCT00559585 (ClinicalTrials.gov)	January 2008	15/11/2007	Methotrexate-Inadequate Response Study	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate	Rheumatoid Arthritis (RA)	Drug: Subcutaneous (SC) Abatacept;Drug: Intravenous (IV) Abatacept	Bristol-Myers Squibb	NULL	Completed	18 Years	N/A	All	2492	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Austria;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

NCT01001832
(ClinicalTrials.gov)

December 2009

26/10/2009

Efficacy, Pharmacokinetics, Safety, and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japanese Patients

A Phase II/III, Multicenter, Randomized, Double-Blind, Double-Dummy Study to Assess Similarity of the Efficacy, Pharmacokinetics, Safety and Immunogenicity of Abatacept Administered Subcutaneously or Intravenously in Japanese Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Intravenous (IV) abatacept;Drug: Subcutaneous (SC) abatacept

Bristol-Myers Squibb

NULL

Completed

20 Years

N/A

All

118

Phase 2;Phase 3

Japan

NCT00559585
(ClinicalTrials.gov)

January 2008

15/11/2007

Methotrexate-Inadequate Response Study

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Rheumatoid Arthritis (RA)

Drug: Subcutaneous (SC) Abatacept;Drug: Intravenous (IV) Abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

2492

Phase 3

United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;France;Germany;Greece;Hungary;India;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Peru;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Austria;Spain