rheumatoid arthritis
Conditions
Interventions
PRALIA 60mg subcutaneous injection every 6 months for 36 months.
Sponsors
Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who are 20 years old or more at the time of consent acquisition. (2)Patients with RA diagnosed according to 1987 ACR criteria or 2010 ACR / EULAR criteria for RA. (3)Patients from which written informed consent to participate in this trial was obtained.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The value of EQ-5D at 42 months after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| inflammatory cytokine, Bone mineral density, bone turnover marker, blood test data, disease activity, image evaluation, adverse event, the retention rate | — |
Countries
Japan
Contacts
Public ContactShinya Hayashi
Kobe University Hospital Department of Orthopaedic Surgery
Outcome results
None listed