rheumatoid arthritis
Conditions
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of RA according to the 2010 ACR/EULAR classification criteria • Current treatment with RTX (at time of inclusion have already received at least 2 cycles of 1000mg RTX) at the Day-Clinic of the Division of Rheumatology of the Medical University of Vienna • Persistent low disease activity or clinical remission. Persistent clinical remission (pREM) will be defined as a simplified disease activity index (CDAI) =2.8 measured at two time-points 6 months apart. The CDAI is calculated as follows: TJC + SJC + GH + EGH (EGH=evaluator's assessment of general health on a 100 mm VAS, GH=patient's assessment of general health on a 100 mm VAS, SJC=28 swollen joint count, TJC=28 tender joint count). • Persistent low disease activity (pLDA) will be defined as a CDAI =10 measured at two timepoints 6 months apart • Patients who achieve REM at only either one of the two successive time-points will be considered as having pLDA with regard to the current trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Patients = 18 yrs • Patients receiving RTX for a disease other than RA • Patients who fail to meet criteria for REM or LDA at either one of the two successive timepoints (i.e. having a disease activity >10 as measured by the CDAI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether a reduced-dose dosing regimen (1x500mg semiannually) of rituximab (RTX) (Mabthera®) is non-inferior in patients with rheumatoid arthritis (RA) whose disease is in persistent low disease activity (LDA) or clinical remission (REM) (pLDA/pREM) as compared to the standard dosing regimen of 1x1000mg semi-annual infusions.;Secondary Objective: not applicable;Primary end point(s): Primary end points will be the proportions of flares in both groups evaluated by the disease activity score 28 (DAS28). Disease flare will be defined as a change in DAS28 of >1.2 or an increase in DAS28 of 0.6-1.2 if this results in DAS28 >3.2 ("reverse" EULAR improvement criteria). DAS28 is defined as follows: 0.56 * sqrt(TJC) + 0.28 *sqrt(SJC) + 0.70*ln(ESR) + 0.014*GH. ESR=erythrocyte sedimentation rate.;Timepoint(s) of evaluation of this end point: months 3, 6, 9, 12, 15, 18, 21, 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures will include radiographic progression as measured by change in the Sharp modified van der Heijde (SvdH) score on standard radiographs, as well as physical function, as measured by the health assessment questionnaire disability index (HAQ-DI).;Timepoint(s) of evaluation of this end point: months 12, 24 | — |
Countries
Austria
Contacts
Public ContactMedical University of Vienna
Medical University of Vienna
Outcome results
None listed