Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission

Rheumatoid Arthritis Clinical Trial

— REDOREM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05116228
• Other study ID #: 2015-002156-27
• Status: Terminated
• Phase: Phase 4
• Start date: September 1, 2015
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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))

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Remission
• Rheumatoid Arthritis

Intervention

Drug:
• 500mg 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
• 1000mg 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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of flare	Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)	month 24
Secondary	Radiographic progression	Sharp modified van der Heijde (SvdH) score, Scale 0 (best) - 488 (worse)	month 12
Secondary	Radiographic progression	Sharp modified van der Heijde (SvdH) score, Scale 0 (best) - 488 (worse)	month 24
Secondary	Physical function	Health assessment questionnaire disability index (HAQ-DI), Scale 0 (best) - 3.0 worse	months 12
Secondary	Physical function	Health assessment questionnaire disability index (HAQ-DI), Scale 0 (best) - 3.0 worse	months 24
Secondary	Proportion of flare	Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)	month 21
Secondary	Proportion of flare	Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)	month 18
Secondary	Proportion of flare	Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)	month 15
Secondary	Proportion of flare	Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)	month 12
Secondary	Proportion of flare	Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)	month 9
Secondary	Proportion of flare	Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)	month 6
Secondary	Proportion of flare	Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)	month 3