Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis

A Phase IV, Open labeled, Multi-Center Trial to Assess the Efficacy and Safety of Tacrolimus(Tacrobell®)in patients with active rheumatoid arthritis(RA).

Inclusion criteria

• Male or female aged ≥20years
• Signed and dated informed consent document indicating that the patient
• Women of childbearing potential must have a negative serum or urine pregnancy test at the screening visit. Except in the case of surgically sterile or amenorrhea for one year.
• Female patients must agree to use adequate contraception measures during the period of therapy which should be continued for 4 weeks.
• have RA and meet all of the following criteria; RA occurring ≥ 3months and less than 15 years and diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis; Active RA patients with MTX and among them who has insufficiency response to DMARDs as defined DAS28>3.2 in active RA patient. Insufficiency response is defined despite MTX therapy for > 12 weeks, RA activity≥ more than moderate and confirmable during 12 weeks, sequence of taking MTX >7.5mg/week for more than 6 weeks; ESR≥28mm/h or CRP≥1.0mg/dl; Tender Joint Counts must be more than 6 and Swollen Joint Counts must be more than 3

Exclusion criteria

• Inflammatory joint diseases, Systematic inflammatory disease
• Prosthesis and had an event of infected in it.
• Medical history of chronic infection, moderate infection or possibly to life threatening or signs and symptoms of serious infection.
• Patients have received treatment with a live vaccine from baseline within 8 weeks.
• HBsAg positive and hepatitis C virus positive patient.
• Patients have a history of malignancy. (But, carcinoma in situ of the uterine cervix or basal cell carcinoma have been treated is allowed within 5years)
• Patients have cardiovascular disease or associated disease which is not controlled.
• uncontrollable blood sugar(HbA1C ≥8%) or required insulin.
• Patients with a history of operation on index knee joint which could have influence on the result and need to have surgery as determined by investigator.
• At screening, patients have laboratory result as defined by ; white blood cell(WBC) < 3,500/mm3, Absolute Neutrophil Count(ANC) < 1,500/mm3, Hemoglobin < 8.5g/dl, Platelet count(PLT) < 100,000/mm3, Serum creatinine >1.5*upper limit of normal or 2mg/dl, Total bilirubin > 2*upper limit of normal, aspartate aminotransferase(AST) > 2*upper limit of normal, alanine aminotransferase(ALT) > 2*upper limit of normal, alkaline phosphatase(ALP) > 2*upper limit of normal
• Patients on any other clinical trial or experimental treatment in the past 8weeks
• An impossible one who participates in clinical trial by investigator's decision