Rheumatoid Arthritis
Conditions
Interventions
None listed
Sponsors
University of Occupational and Environmental Health, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "programmed" treatment (Programmed treatment arm), whose dose of IFX for each patient is determined by the baseline TNF-alpha level IFX 3mg/kg is administered on week 0, 2 and 6. After week 14, dose of IFX for each patient is determined by the baseline TNF-alpha level as follows; TNF-alpha < 0.55pg/mL: IFX 3mg/kg is continued every 8 weeks. 0.55pg/mL =< TNF-alpha < 1.65pg/mL: IFX 6mg/kg is administered on week 14. IFX 6mg/kg is continued every 8 weeks. TNF-alpha >= 1.65pg/mL: IFX 6mg/kg is administered on week 14 and IFX 10mg/kg is administered on week 22. IFX 10mg/kg is continued every 8 weeks. In all cases, IFX is discontinued at the time of 54 weeks after the first administration of IFX.
Exclusion criteria
Exclusion criteria: "standard" treatment (standard treatment arm), whose dose was fixed as 3mg/kg every 8 weeks IFX 3mg/kg is administered on week 0, 2 and 6. After week 14, IFX 3mg/kg is continued every 8 weeks. IFX is discontinued at the time of 54 weeks after the first administration of IFX.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients maintaining discontinuation of IFX at 1 year after a discontinuation of IFX at the time of 54 weeks after the first administration of IFX Proportion of structual remission 1 yer after enrolloing in RRRR-EX study | — |
Countries
Japan
Contacts
Public ContactNao Horie
Hokkaido University Hospital Translational Research and Clinical Trial Center
Outcome results
None listed