Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX)
Conditions
Interventions
Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks.
Etanercept group patient receive weekly subcutaneous injection of etanerc
Sponsors
Department of Rheumatology and infectious disease, Kitasato university school of medicine
1)Kitasato institute medical center hospital 2)Kitasato institute hospital 3)Ishikawa internal medicine clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is diagnosed with RA according to the American College of Rheumatology / European League Against Rheumatism (ACR/EULAR) classification criteria 2010. 2) outpatients who don't participate in other clinical trial. 3) Patients with inadequate response to MTX more than 8mg/weeks dosage for more than 12weeks. 4) Subject has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patient who is contraindicated for tacrolimus and etanercept. 2) RA patient treated with tacrolimus and/or biologics before the study. 3) PSL dosage is more than 7.5mg/day and increased within 4weeks before the study. 4) patient who has been judged inappropriate to the study by responsible doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The American College of Rheumatology 20% response (ACR20) at week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint variables include Disease activity score in 28 joints (DAS28), simplified disease activity index (SDAI), clinical disease activity index (CDAI), modified Health Assessment Questionaire (m-HAQ), protocol persistence rate, and adverse event. | — |
Countries
Japan
Contacts
Public ContactTatsuhiko Wada
Kitasato university school of medicine Rheumatology and infectious disease
Outcome results
None listed