Rheumatoid arthritis
Conditions
Interventions
Double the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<
=10 is maintained.
Sponsors
Nagoya University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with RA fulfilled the ACR 1987 classification criteria or ACR/EULAR 2010 classification criteria 2) Patients who had a CRP concentration of >=0.6mg/dl at initiation of TCZ 3) Patients maintaining low disease activity with a CDAI of <=10 with TCZ and MTX for at least 12 weeks 4) Patients receiving stable treatment without alteration in dosage and administration for at least 12 weeks
Exclusion criteria
Exclusion criteria: 1) Patients receiving TCZ and/or MTX for any disease other than RA 2) Patients judged as inadequate at the discretion of physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients maintaining CDAI<=10 at 36 weeks (24weeks after stopping MTX) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients maintaining CDAI<=10 at 12 weeks (after reducing MTX) and 64 weeks (52weeks after stopping MTX) 2) Disease activity, serum concentration of TNF-alpha and IL-6, FSSG score, and EQ-5Dat each visit 3) Proportion of patients regaining CDAI<=10 4) Predictors of maintaining CDAI<=10 5) Adverse events | — |
Countries
Japan
Contacts
Public ContactShuji Asai
Nagoya University Hospital Center for Advanced Medicine and Clinical Research
Outcome results
None listed