Clinical trial NCT05116228: Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission
Official title: Randomized, Prospective, Active-comparator Controlled, Patient-blinded Study to Demonstrate Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis Patients in Low Disease Activity and Remission - the REDOREM Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Remission
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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))

Primary outcomes:
measure: Proportion of flare
timeFrame: month 24
Secondary outcomes:
measure: Radiographic progression
timeFrame: month 12
measure: Radiographic progression
timeFrame: month 24
measure: Physical function
timeFrame: months 12
measure: Physical function
timeFrame: months 24
measure: Proportion of flare
timeFrame: month 21
measure: Proportion of flare
timeFrame: month 18
measure: Proportion of flare
timeFrame: month 15
measure: Proportion of flare
timeFrame: month 12
measure: Proportion of flare
timeFrame: month 9
measure: Proportion of flare
timeFrame: month 6
measure: Proportion of flare
timeFrame: month 3
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: