Changes in MTX-PG Concentrations During Subcutaneous MTX Therapy in Patients With Rheumatoid Arthritis(COSMOS Study)

Ki vehet részt

• 1) Patients who were previously untreated with MTX, regardless of route of administration 2) Patients aged >=18 years at the time of informed consent 3) Patients who meet 2010 EULAR/ACR criteria 4) Patients who have disease activity of SDAI >11 at screening 5) Patients who were previously untreated with JAK inhibitor or bDMARDs 6) Female of child-bearing potential who can use appropriate contraceptive during the study and for at least one menstrual period after completion of MTX administration, female in whom time from menopause to informed consent is >=1 year, or female of no child-bearing potential through sterilization 7) Virile male who can use appropriate contraceptive during the study and for at least three months after completion of MTX administration 8) Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study

Ki nem vehet részt

• 1) Pregnant women or women who may be pregnant 2) Patients with a history of hypersensitivity to any ingredient of the study drug 3) Patients with serious hematologic and lymphatic disorders
• Patients with a history of myelodysplastic syndrome, aplastic anemia, or erythroblastoma
• Patients with a diagnosis or treatment of lymphoproliferative disease within the past 5 years
• Patients with acute or chronic active viral hepatitis B or C
• Patients with significant leukopenia (white blood cell count <3000/mm3) or thrombocytopenia (platelet count <50000/mm3millimeter) 4) Patients with significant hepatic impairment
• Patients with other significant hepatic impairment (AST >150 U/L or ALT >150 U/L) 5) Patients with severe renal impairment The following criteria should be used as a reference
• Dialysis patients or renal dysfunction correspon ding to renal glomerular filtration rate (GFR) <30 mL/min/1.73 m2 6) Patients who have pleural effusion or ascites 7) Patients who have active tuberculosis 8) Patients otherwise whom principal investigator/sub- investigator considered medically ineligible to participate in the study
• Patients diagnosed with cirrhosis