Rheumatoid arthritis arthritis, chronic kidney disease
Conditions
Interventions
Empagliflozin 10 mg once daily for 52 plus or minus 2 weeks
Sponsors
Hiromitsu Asashima
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with rheumatoid arthritis according to the 2010 ACR-EULAR classification criteria and who initiated methotrexate (MTX) treatment within 52 weeks prior to the eligibility assessment date. 2. Patients with at least one test result showing rheumatoid factor (RF) or anti-citrullinated protein antibody (ACPA) above the reference range on or before the eligibility assessment date. 3. Patients aged 18 years or older and under 80 years on the date of informed consent. 4. Patients who, during the eligibility assessment period, are not scheduled to discontinue MTX after the eligibility assessment date. 5. Patients whose continuous duration of discontinuation from MTX is 4 weeks or less between 52 weeks prior to the eligibility assessment date and the eligibility assessment date. 6. Patients with no history of treatment with any of the following drugs prior to the eligibility assessment date: empagliflozin (Jardiance), dapagliflozin (Forxiga), ipragliflozin (Suglat), luseogliflozin (Lusefi), tofogliflozin (Deberza), or canagliflozin (Canaglu). 7. Patients who provided written informed consent of their own free will after receiving sufficient explanation. If the patient cannot sign, a witness may sign on behalf of the patient.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of hypersensitivity to any component of the study drug as of the eligibility assessment date. 2. Patients with a history of diabetes mellitus as of the eligibility assessment date or with random plasma glucose >= 200 mg/dl or HbA1c >= 6.5% on blood tests performed on or immediately before the eligibility assessment date. 3. Patients with a history of hypoglycemia requiring glucose administration as of the eligibility assessment date. 4. Patients with a history of dehydration requiring hospitalization between 52 weeks prior to the eligibility assessment date and the eligibility assessment date. 5. Patients who experienced urinary or genital tract infections requiring antibiotic treatment between 52 weeks prior to the eligibility assessment date and the eligibility assessment date. 6. Patients with AST >= 100 U/L or ALT >=100 U/L on blood tests performed on or immediately before the eligibility assessment date. 7. Patients with an estimated glomerular filtration rate (eGFR) of less than 50 mL/min/1.73 m2 or greater than or equal to 100 mL/min/1.73 m2 on blood tests performed on or immediately before the eligibility assessment date. 8. Patients with a body mass index (BMI) of 18 or less on the eligibility assessment date. 9. Patients with a systolic blood pressure below 100 mmHg on the eligibility assessment date. 10. Patients with severe infections or serious trauma on the eligibility assessment date. 11. Patients who are pregnant on the eligibility assessment date. 12. Any other patients deemed ineligible for participation by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and types of adverse events observed during empagliflozin administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in eGFR slopes between the control observation period and the treatment observation period 2. Difference in eGFR change during the control observation period and the treatment observation period 3. Change in body weight and BMI from immediately before initiation of empagliflozin to 52 plus or minus 2 weeks after initiation 4. Change in DAS28-CRP (a disease activity index for RA) from immediately before initiation of empagliflozin to 52 plus or minus 2 weeks after initiation 5. Change in HbA1c from immediately before initiation of empagliflozin to 52 plus or minus 2 weeks after initiation | — |
Contacts
Public ContactAsashima Hiromitsu
University of Tsukuba Hospital
Outcome results
None listed