rheumatoid arthritis
Conditions
Interventions
Infliximab and Methotrexate. Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with rheumatoid arthritis diagnosed according to the criteria of the American College of Rheumatology (ACR). Patient treated of TCZ for more than 12 weeks. SDAI Score more than 3.3 of TCZ treatment the last. SDAI score 3.3 or more at start of the examination (exceeds 3 weeks from TCZ treatment the last.) Having received and thoroughly understood an adequate explanation about participation in the study, patients who have personally and voluntarily provided written informed consent.
Exclusion criteria
Exclusion criteria: Patient has received IFX in the past. During a TCZ washout period, Patient treated of biologics and immunosuppressant which does not have adaptation of preparation or rheumatoid arthritis. Patient is contraindication of IFX and MTX.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The remission rate by SDAI score at 54 weeks. | — |
Countries
Japan
Contacts
Public ContactACRO
NPO Advanced Clinical Research Organization Advanced Clinical Research Organization
Outcome results
None listed