Rheumatoid arthritis
Conditions
Interventions
Period :12 months Patients take Tofacitinib 5mg twice a day.
Sponsors
Kyusyu University Hospital Medicine and biosystemic science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient who fulfills the 1987 ACR classification or the 2010 ACR/EULAR classification criteria for RA 2. A patient who has understood adequately about this study and given informed consent personally and voluntarily. 3. A patient who is 20 years of age and older. 4. A patient who has active arthritis despite adequate treatment with MTX (over 8mg/week, over 3 months) The definition of active arthritis: 1) A patient who meets all of the followings (a-c). a. Equal or more than 6 swollen joints b. Equal or more than 6 tender joints c. Equal or more than CRP 2.0mg/dL or ESR 28mm/hr 2) A patient who has moderate activity; equal or more than DAS28-ESR 3.2 or SDAI 26 or CDAI 22. 5. A patient who meets all of followings: equal or more than 4000/mm3 peripheral WBC, 1000/mm3 periphera Lymphocyte and negative for beta-D-glucan.
Exclusion criteria
Exclusion criteria: 1.A patient with tuberculosis or non-tuberculous mycobacteria. 2 .A patient who is positive for HBs antigen or HBV DNA not receiving nucleotide analogue. 3. A patient who has an active infectious disease. 4. A patient who has concurrent malignancy or its previous history. 5. A patient with reduced renal function less than CLcr15/min. 6. A patient with reduced hepatic function more than 10 points of Child-Pugh score (grade C) 7. A patient with interstitial pneumonia. 8. A pregnant or breastfeeding women or a women who may be pregnant. 9. A patient who has hypersensitivity reaction to ingredients in this drug. 10. A patient who meets any of followings: less than 1000/mm3 peripheral neutrophils or less than 8g/dL hemoglobin. 11. A patient who is regarded as inappropriate to participate in the study by a doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate at 3.6.9.12 months by DAS, SDAI, CDAI and Boolean index. | — |
Secondary
| Measure | Time frame |
|---|---|
| HAQ-DI improvement rate at 3,6,9,12 months. Ultrasonography, the rate and number of subset of lymphocyte, serum cytokine concentration, phosphorylation level of intracellular signaling molecules at 6,12 months modified Total Sharp Score (mTSS) at 12months | — |
Countries
Japan
Contacts
Public ContactYojiro Arinobu
Kyusyu University Hospital Medicine and biosystemic science
Outcome results
None listed