Reduced-dose Rituximab in rheumatoid arthritis patients in remission – the REDOREM study

• Register: EUCTR
• Last refreshed on: 17 February 2025
• Main ID: EUCTR2015-002156-27-AT
• Date of registration: 30/09/2015
• Prospective Registration: Yes
• Primary sponsor: Medical University of Vienna
• Public title: Reduced-dose Rituximab in rheumatoid arthritis patients in remission – the REDOREM study
• Scientific title: Prospective controlled study of reduced-dose Rituximab in rheumatoid arthritis patients in low disease activity and remission – the REDOREM study
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002156-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: MabThera Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Austria

Contacts

• Name: Medical University of Vienna
• Affiliation: Medical University of Vienna

• Name: Medical University of Vienna
• Affiliation: Medical University of Vienna

Key inclusion & exclusion 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:
• 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

rheumatoid arthritis

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: MabThera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)

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.

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.

Timepoint(s) of evaluation of this end point: months 3, 6, 9, 12, 15, 18, 21, 24

Secondary Outcome(s)

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

Secondary ID(s)

1356/2015

Source(s) of Monetary Support

Medical University of Vienna

Ethics review

Status: Approved
Approval date:
Contact: