rheumatoid arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: RA patients who fulfill the following criteria in Hoyogo Colledge of Medicine, Kobe Kaisei Hospital, Konan Kakogawa Hospital, or Kakogawa central city Hospital. 1)Written informed consent provided 2)RA satisfying either the 1987 ACR criteria or 2010 ACR/EULAR criteria 3)active disease with methotrexate treatment or oral conventional synthetic DMARDs for over 3 months (stable dose for at least 4 weeks) 4)Prior use of biological agent is permitted
Exclusion criteria
Exclusion criteria: 1)chronic kidney (eGFR<50ml/min/1.73m2) 2)svere infection or tuberculosis 3)Neutrophils<500/ul, lymphocytes<500/ul 4)Pregnant woman 5)Complication of malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of ACR20 at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) change of DAS28ESR and CDAI (week 4, 8, 12, 24, 52) 2) the remission rate of DAS28ESR and CDAI (week 12) 3)Achievement rate ofACR20 (week 4, 8, 24, 52), 50, 70 (week 4, 8, 12, 24, 52) 4) Biomarker (CRP, ESR, MMp-3, RF) 5)change of ACR core set (week 4, 8, 12, 24, 52) 6) Radiograghic X ray | — |
Countries
Japan
Contacts
Hyogo Medical University Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine