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	NCT02057250 (ClinicalTrials.gov)	March 2014	31/1/2014	To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis	A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy	RA	Drug: Sarilumab;Device: Auto-Injector Device (AID);Device: Pre-filled Syringe (PFS);Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Hydroxychloroquine	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	217	Phase 3	United States;Chile;Mexico;Poland;Russian Federation;South Africa;France

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

NCT02057250
(ClinicalTrials.gov)

March 2014

31/1/2014

To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis

A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy

Drug: Sarilumab;Device: Auto-Injector Device (AID);Device: Pre-filled Syringe (PFS);Drug: Methotrexate;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Hydroxychloroquine

Sanofi

Regeneron Pharmaceuticals

Completed

18 Years

N/A

All

217

Phase 3

United States;Chile;Mexico;Poland;Russian Federation;South Africa;France