Rheumatoid Arthritis
Conditions
Interventions
"
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 ea
TNF-alpha <
0.55pg/mL: IFX 3mg/kg is continued every 8 weeks. 0.55pg/mL =<
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
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 discontinu
Sponsors
University of Occupational and Environmental Health, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) rheumatoid arthritis, 2) refractory patients despite methotrexate, 3) patients who have never treated with IFX, 4) written informed consent
Exclusion criteria
Exclusion criteria: 1) patients who use steroid over 10mg/day (prednisolone-equivalent), 2) SDAI =< 11.0, 3) severe infection, 4) active tuberculosis, 5) demyelinating disease, 6) congestive heart failure, 7) Patient who is lactating, pregnant, possibly pregnant or do not agree with anti-conception during the trial and 6 month after the last administration of IFX, 8) patients who are inadequate to enter this trial due to the other reasons by physician's judgments
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 | — |
Countries
Japan
Contacts
Public ContactNao Horie
Hokkaido University Hospital Translational Research and Clinical Trial Center
Outcome results
None listed