Rheumatoid Arthritis
Conditions
Interventions
None listed
Sponsors
Seirei Hamamatsu General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) RA patients 18 years of age or older 2) Patients who have been taking MTX for at least 12 weeks (the same dose for at least 2 weeks at the time of enrollment) 3) Patients who have gastrointestinal symptoms such as nausea, vomiting, anorexia, or fatigue even after receiving 10 mg or 15 mg/week of foliac acid or 1 mg daily, and who have difficulty continuing MTX or require a dose reduction. (4) Patients who have been fully informed of the study and who have given written consent of their own free will after sufficient understanding of the study
Exclusion criteria
Exclusion criteria: 1) Patients under 18 years of age 2) Patients with drug allergy to MTX 3) Patients with serious liver disease (Grade 3 or higher in CTCAE Ver5.0) 4) Patients with serious renal disease (eGFR <30) 5) Patients with severe interstitial pneumonia 6) Patients with hematologic malignancies 7) Patients with pleural effusion or ascites 8) Patients with active tuberculosis or other infectious diseases 9) Women who are pregnant or may become pregnant 10) Women who are breast-feeding 11) Patients with cognitive impairment and inability to maintain adherence 12) Other patients who are deemed inappropriate as research subjects by the principal investigator or research coordinator. 12) Other patients deemed inappropriate as research subjects by the principal investigator or principal investigator's assistant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in nausea VAS from 0 to 13 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of change in fatigue VAS from 0 to 13 weeks of treatment. Change in RA disease activity (DAS28, DAS28ESR, SDAI, CDAI) from Week 0 to Week 13 of treatment | — |
Countries
Japan
Contacts
Public ContactShin-ichiro Ohmura
Seirei Hamamatsu General Hospital Department of the Rheumatology
Outcome results
None listed