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	NCT02373813 (ClinicalTrials.gov)	February 20, 2015	12/1/2015	Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: etanercept pre-filled syringe sq injection;Drug: Oral methotrexate;Drug: Placebo for etanercept sq injection;Drug: Placebo for methotrexate	Amgen	NULL	Completed	18 Years	N/A	All	371	Phase 3	United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic
2	EUCTR2006-005137-38-DE (EUCTR)	23/10/2007	23/08/2007	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:	Trade Name: Enbrel Product Name: Etanercept Pre-filled syringe INN or Proposed INN: ETANERCEPT Product Name: Etanercept Auto-Injector Product Code: L04AA11 INN or Proposed INN: ETANERCEPT	Wyeth Pharmaceuticals France	NULL	Not Recruiting			Female: yes Male: yes	534		France;Finland;Denmark;Germany;United Kingdom;Sweden

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

NCT02373813
(ClinicalTrials.gov)

February 20, 2015

12/1/2015

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: etanercept pre-filled syringe sq injection;Drug: Oral methotrexate;Drug: Placebo for etanercept sq injection;Drug: Placebo for methotrexate

Amgen

NULL

Completed

18 Years

N/A

All

371

Phase 3

United States;Argentina;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Mexico;Poland;Portugal;South Africa;Spain;Czech Republic

EUCTR2006-005137-38-DE
(EUCTR)

23/10/2007

23/08/2007

A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.

Rheumatoid Arthritis
MedDRA version: 6.0;Level: LLT;Classification code 10039073;Term:

Trade Name: Enbrel
Product Name: Etanercept Pre-filled syringe
INN or Proposed INN: ETANERCEPT
Product Name: Etanercept Auto-Injector
Product Code: L04AA11
INN or Proposed INN: ETANERCEPT

Wyeth Pharmaceuticals France

NULL

Not Recruiting

Female: yes
Male: yes

534

France;Finland;Denmark;Germany;United Kingdom;Sweden