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	NCT01793259 (ClinicalTrials.gov)	July 2012	14/2/2013	Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)	An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: methotrexate prefilled pen;Drug: methotrexate prefilled syringe	medac GmbH	NULL	Completed	18 Years	75 Years	Both	120	Phase 3	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

NCT01793259
(ClinicalTrials.gov)

July 2012

14/2/2013

Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)

An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis

Drug: methotrexate prefilled pen;Drug: methotrexate prefilled syringe

medac GmbH

NULL

Completed

18 Years

75 Years

Both

120

Phase 3

Germany