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
97	潰瘍性大腸炎	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	EUCTR2014-000656-29-BE (EUCTR)	13/06/2014	05/03/2014	Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device	Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART	Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi	MSD Belgium BVBA/SPRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium

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

EUCTR2014-000656-29-BE
(EUCTR)

13/06/2014

05/03/2014

Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device

Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART

Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Trade Name: Simponi® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Simponi
Trade Name: Simponi® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Simponi

MSD Belgium BVBA/SPRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Belgium