A clinical study to evaluate the correlation between the efficacy and the immunological markers in patients with rheumatoid arthritis treated with Tofacitinib.
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000020663
- Lead Sponsor
- Kyusyu University Hospital Medicine and biosystemic science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission rate at 3.6.9.12 months by DAS, SDAI, CDAI and Boolean index.
- Secondary Outcome Measures
Name Time Method 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