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	NCT01211249 (ClinicalTrials.gov)	October 2010	28/9/2010	GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis	Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination With Methotrexate, Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate	Rheumatoid Arthritis	Drug: GLPG0259 oral capsule;Drug: Placebo;Drug: GLPG0259 (Part B);Drug: Placebo (Part B)	Galapagos NV	NULL	Completed	18 Years	70 Years	Both	30	Phase 2	Belgium;Netherlands;Poland;Russian Federation;Ukraine

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

NCT01211249
(ClinicalTrials.gov)

October 2010

28/9/2010

GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis

Randomized, Double-Blind, Placebo-Controlled, Multicenter, Exploratory Phase II Study to Compare Three Dose Regimens of GLPG0259 vs Placebo, in Combination With Methotrexate, Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Rheumatoid Arthritis

Drug: GLPG0259 oral capsule;Drug: Placebo;Drug: GLPG0259 (Part B);Drug: Placebo (Part B)

Galapagos NV

NULL

Completed

18 Years

70 Years

Both

Phase 2

Belgium;Netherlands;Poland;Russian Federation;Ukraine