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	EUCTR2012-000222-21-DE (EUCTR)	31/05/2012	16/03/2012	Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection.	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 - Preference MTX pre-filled syringe vs pre-filled pen in RA	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze Product Code: 70930.00.00 INN or Proposed INN: Methotrexate disodium Product Name: methotrexate pre-filled pen INN or Proposed INN: Methotrexate disodium	medac Gesellschaft für klinische Spezialpräparate mbH	NULL	Not Recruiting			Female: yes Male: yes			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

EUCTR2012-000222-21-DE
(EUCTR)

31/05/2012

16/03/2012

Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection.

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 - Preference MTX pre-filled syringe vs pre-filled pen in RA

Rheumatoid Arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Code: 70930.00.00
INN or Proposed INN: Methotrexate disodium
Product Name: methotrexate pre-filled pen
INN or Proposed INN: Methotrexate disodium

medac Gesellschaft für klinische Spezialpräparate mbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany