Remission, Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
Randomized, controlled, single-centre study with 1x500mg or 1x1000 semi-annual infusions of RTX (Mabthera) as intervention and a follow-up period of 2 years. Patients as well as assessors will be blinded to the type of treatment. Patients in the 1x500mg group who experience a flare as defined by the disease activity score 28-ESR (DAS28) will receive 1x1000mg RTX (Mabthera) at their upcoming scheduled infusion appointment. Patients in the 1x1000mg group whose disease activity reaches DAS28 \>3.2 during the duration of the study will be re-evaluated for a change in biological therapy and will discontinue the study.
Interventions
DRUG500mg RTX Group
Patients will receive 1x500mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24
DRUG1000mg RTX Group
Patients will receive 1x1000mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of RA according to the 2010 American College of Rheumatology (ACR) / European League Against Rheumatism (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 as defined below * Persistent clinical remission (pREM) will be defined as a simplified disease activity index (CDAI) (12) ≤2.8 measured at two time-points 6 months apart. The CDAI is calculated as follows: tender joint count (TJC) + swollen joint count (SJC) + patient's assessment of general health on a 100 mm visual analogue scale (GH) + evaluator's assessment of general health on a 100 mm visual analogue scale (EGH) * 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
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 clinical disease activity index, (CDAI))
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of flare | month 24 | Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic progression | month 12 | Sharp modified van der Heijde (SvdH) score, Scale 0 (best) - 488 (worse) |
| Physical function | months 12 | Health assessment questionnaire disability index (HAQ-DI), Scale 0 (best) - 3.0 worse |
| Proportion of flare | month 21 | Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse) |
Countries
Austria
Outcome results
None listed