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	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	NCT00595413 (ClinicalTrials.gov)	September 2007	7/1/2008	Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)	A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFa-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: Placebo matched to atacicept;Drug: Atacicept: with loading dose;Drug: Atacicept;Biological: Adalimumab	EMD Serono	Merck KGaA	Completed	18 Years	N/A	All	311	Phase 2	United States;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

NCT00595413
(ClinicalTrials.gov)

September 2007

7/1/2008

Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)

A Randomised, Double-blind, Placebo Controlled, Multi-centre Phase II Study of Atacicept in Anti-TNFa-naïve Patients With Moderate to Severely Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: Placebo matched to atacicept;Drug: Atacicept: with loading dose;Drug: Atacicept;Biological: Adalimumab

EMD Serono

Merck KGaA

Completed

18 Years

N/A

All

311

Phase 2

United States;Germany