Rheumatoid arthritis
Conditions
Interventions
investigational material(s)
Generic name etc : SA237
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigationa
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with rheumatoid arthritis of ≥ 6 months duration, diagnosed according to the revised 1987 ACR criteria - Patients with CRP > ULN at screening
Exclusion criteria
Exclusion criteria: - Any major episode of infection within 4 weeks prior to first dose - Active chronic hepatitis B and C - Active tuberculosis - Active interstitial pneumonia - History of serious allergic reactions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, immunogenicity, PK/PD Observation/examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Observation/examination | — |
Outcome results
None listed