Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

May 31, 2007

Study Completion Date

May 31, 2007

Conditions
Rheumatoid Arthritis
Interventions
DRUG

TA-650 3 mg/kg

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

DRUG

TA-650 6 mg/kg

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6 weeks. Then 6 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

DRUG

TA-650 10 mg/kg

3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46.

All Listed Sponsors
lead

Mitsubishi Tanabe Pharma Corporation

INDUSTRY