Efficacy and safety of the subcutaneous Methotrexate in patients with Rheumatoid arthritis who can not tolerate oral MTX due to gastrointestinal symptoms
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-UMIN000052344
- Lead Sponsor
- Seirei Hamamatsu General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in nausea VAS from 0 to 13 weeks
- Secondary Outcome Measures
Name Time Method Comparison of change in fatigue VAS and anorexia VAS from 0 to 13 weeks of treatment