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

CompletedPhase 3

Sponsor: Tanabe Pharma Corporation

Conditions: Rheumatoid Arthritis

Interventions: TA-650 3 mg/kg, TA-650 6 mg/kg, TA-650 10 mg/kg

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.

Eligibility overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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