Rheumatoid Arthritis
Conditions
Interventions
This is a multicenter study of patients with RA who are untreated with MTX residing in Japan. Subjects (SDAI > 11) will be started on oral MTX at 6-8 mg/week and promptly titrate up to the maximum tol
Sponsors
Kaneko Yuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 significant leukopenia (white blood cell count 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 corresponding 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MTX-PG concentrations in erythrocytes from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients who achieved remission of SDAI, CDAI, DAS28-ESR, or DAS28-CRP at Weeks 12 and 24 2) Measured values at each assessment timepoint and change from baseline and Week 12 to each assessment timepoint in SDAI, CDAI, DAS28-ESR, or DAS28-CRP 3) Proportion of patients who achieved ACR20/50/70 response at each assessment timepoint 4) Measured values at each assessment timepoint and change from baseline and Week 12 to each assessment timepoint in tender joint count, swollen joint count, VAS (physician global assessment, patient global assessment, patient pain assessment), HAQ, ESR, or CRP 5)Association between MTX-PG concentrations in erythrocytes at Weeks 12 and 24 and change in SDAI, CDAI, DAS28-ER, or DAS28-CRP 6) Incidence of adverse events | — |
Contacts
Public ContactKazuoto Hiramoto
Keio University Hospital
Outcome results
None listed