Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)

PHASE3CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

November 30, 2009

Study Completion Date

July 31, 2010

Conditions
Crohn's Disease
Interventions
DRUG

TA-650

(1) Screening Period: 5 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at week 0. If patients do not meet the Eligibility Criteria at week 8, they will be administered 5 mg/kg of TA-650 at week 8. (2) Increased Dose Period: 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours every 8 weeks for 32 weeks.

Trial Locations (4)

Unknown

Investigational site, Hokkaido

Investigational site, Kansai

Investigational site, Kanto

Investigational site, Kyushu

All Listed Sponsors
lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY