Rheumatoid arthritis
Conditions
Interventions
administration of weekly MTX dose at once.
administration by dividing three times of weekly MTX dose.
Sponsors
Yokohama Minami Kyousai Hospital
AYUMI Pharmaceutical corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients, fulfilled the ACR 1987 reviced criteria for the classification of rheumatoid arthritis and patients, fulfilled the ACR/EULAR 2010 criteria for the classification of rheumatoid arthritis. 2)RA patient who had not achieved remission despite 8mg/week or less dose of MTX for at least 4 weeks. 3)Patient who is within 14 days before change of MTX dose. 4)Patient who elapsed at least 8 weeks after if using biologics, JAK inhibitors or immunosuppressants (leflunomide, tacrolimus or mizolibine). 5) Outpatients (there are no schedules of hospitalization during a clinical trial period). 6) Patients who can provide written informed concent by themselves.
Exclusion criteria
Exclusion criteria: (Complication) Patients who had any of the following diagnoses or medical history 1)Autoimmune disease, except for RA and Sjogren's syndrome, and malignancy. 2)Drug allergy 3)Severe heart, lung, liver, kidney and heamatological disorders (Treatment) 4)Patient who recived intramuscular, intoravenous or epidural injection of corticosteroids within 4 weeks prior to the entry or during study 5)Patient who recived intraarticular corticosteroid at dose of over 20mg/month of prednisolone, and at any dose within 4weeks prior to study entry or first end point 6)Pateint whose body weight is less than or equal to 40kg 7)Patient who recived systemic corticosteroid with a dose of>10mg of predonisolone within 4 weeks prior to the study or during the study and patients whose corticosteroid dose were changed within 4 weeks prior to first end point 8)Patient who received NSAIDs with an overdosage within 4 weeks prior to the study entry or during the study. 9) Patient who is currently under treatment or treatmented with biologics, JAK inhibitor or immunosappressants within 8 weeks prior to the study entry. (Surgery) 10)Patient who had surgery judged to have an influence on this study by doctor 11)Patient who had the following treatment or procedure:plasma exchange, leukocyte depleted therapy or arthrocentesis against affected joint. except for the arthrocenesis following intraarticular injection of corticosteroid, within 4 weeks prior to the study entry or during the study (Others) 12)Patient who is in pregnancy, lactating, or with a possibility of the pregnancy and woman who hopes for pregnancy during study or within 1 month after the end of this study, and man who wishes his partner be pregnant during the study or within 3 months after the end of this study 13)Patient who can not go to a hospital for check-up on an appointed day 14)When principal investigator or sub investigators of this study judge the patients disqualified as a subject of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of liver disfunction at Week 20. | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events. The change in DAS28 at Week 20 from Week 0. The change in SDAI at Week 20 from Week 0. Concentrations of MTX polyglutamates in red blood cells at Week 0 and Week 20. Laboratery datas during obsevational term. | — |
Countries
Japan
Contacts
Public ContactMasahiro Okamoto
AYUMI Pharmaceutical Corporation Department of Medical Affers, Division of Research and Development
Outcome results
None listed