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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: TA-650 6 mg/kg; Drug: TA-650 3 mg/kg; Drug: TA-650 10 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00691028

TA-650-13

JapicCTI-050146

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.

Enrollment: 327 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with active RA in spite of stable dose of MTX

Exclusion criteria

• Having received infliximab in the past
• Having a history of serious infection which caused hospitalization within 6 months before the registration
• Having an active tuberculosis
• Having a complication or a history of malignancy within 5 years before the registration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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327 participants in 3 patient groups

TA-650 3 mg/kg

Experimental group

Treatment:

Drug: TA-650 3 mg/kg

TA-650 6 mg/kg

Experimental group

Treatment:

Drug: TA-650 6 mg/kg

TA-650 10 mg/kg

Experimental group

Treatment:

Drug: TA-650 10 mg/kg