An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
Not Applicable
Recruiting
- Conditions
- rheumatoid arthritis
- Registration Number
- JPRN-UMIN000031019
- Lead Sponsor
- Kobe University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Patients with osteoporosis (2)Serum Ca value < 8.0 mg / dL (3)Patients who are treated with RANMARK. (4)Moderate or higher renal failure (5)gingivitis or receiving dental procedures. (6)Dementia or mental disorder. (7)drug hypersensitivity (8)Pregnant women and patients who may be pregnant or breast-feeding patients (9)Patients who participated in other clinical trials within 4 months (10)Patients judged inappropriate for participation in this trial by the person in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The value of EQ-5D at 42 months after administration
- Secondary Outcome Measures
Name Time Method inflammatory cytokine, Bone mineral density, bone turnover marker, blood test data, disease activity, image evaluation, adverse event, the retention rate