Rheumatoid Arthritis
Conditions
Interventions
investigational material(s)
Generic name etc : PRALIA 60 mg Subcutaneous Injection Syringe(denosumab)
INN of investigational material : denosumab
Therapeutic category code : 399 Agents affecting metab
Sponsors
DAIICHISANKYO Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: RA patients who receive PRALIA for the first time
Exclusion criteria
Exclusion criteria: Those who previously used PRALIA for osteoporosis treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety 1.Safety - Incidence by adverse drug reactions/infection type - Incidence of serious adverse events - Safety profile in the patients with PRALIA administration changed to once every 3 months 2.Efficacy - Radiographic assessment of bone erosion progression | — |
Secondary
| Measure | Time frame |
|---|---|
| other - | — |
Countries
Japan
Outcome results
None listed