REDO study: Research into the effects of lower doses rituximab in patients with rheumatoid arthritis

REDO study: RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimization - REDO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002908-15-NL

Enrollment

140

Registered

2016-08-23

Start date

2016-11-08

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis MedDRA version: 19.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: MabThera Pharmaceutical Form: Infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Rheumatoid arthritis: either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion. - RTX retreatment: at least once RTX in the last 18 months for RA in a dose of 1 × 1000 mg, 2 × 1000 mg or 2 × 500 mg and no other biologicals received after last RTX dose. Patients treated with innovator RTX (MabThera) as well as registered biosimilars will be included. - At least 6 months of stable, low disease activity after the last RTX infusion (operationalized by either DAS28-CRP 6 months, no planned relocation out of reach of study centre) - Ability to read and communicate well in Dutch 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) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - Patients with known (non-)response to ultra-low dose RTX (below 1 × 1000 mg) - Current corticosteroid dosing above 10 mg per day prednisolone equivalent

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the difference in efficacy between two ultra-low doses (1 x 200 mg and 1 x 500 mg) and standard low dose (1 x 1000 mg) of rituximab retreatment on the change in DAS28-CRP, compared to a pre-specified non-inferiority margin of 0.6, at 3 and 6 months in patients with RA previously treated with RTX using a conventional dose; Secondary Objective: - To assess the difference in efficacy between the two ultra-low dose interventions - To compare the proportion of patients with low disease activity or remission and remission according to Boolean ACR/EULAR criteria of all groups - To assess the difference in the change from baseline in functioning between all groups. - To assess the difference in change from baseline in quality of life between all groups. - To assess the safety of each dose of RTX - To assess the difference in medication use between all groups. - To assess whether baseline factors are predictive for obtaining DAS28-CRP low disease activity state at 6 months. - To estimate the cost effectiveness of both ultra-low RTX doses compared to the conventional low dose over the 6 months study period. - To compare the course of serum (anti-)RTX levels between all groups. ;Primary end point(s): Change in DAS28-CRP from baseline ; Timepoint(s) of evaluation of this end point: - 3 months follow-up - 6 months follow-up	—

Measure

Time frame

Main Objective: To assess the difference in efficacy between two ultra-low doses (1 x 200 mg and 1 x 500 mg) and standard low dose (1 x 1000 mg) of rituximab retreatment on the change in DAS28-CRP, compared to a pre-specified non-inferiority margin of 0.6, at 3 and 6 months in patients with RA previously treated with RTX using a conventional dose; Secondary Objective: - To assess the difference in efficacy between the two ultra-low dose interventions - To compare the proportion of patients with low disease activity or remission and remission according to Boolean ACR/EULAR criteria of all groups - To assess the difference in the change from baseline in functioning between all groups. - To assess the difference in change from baseline in quality of life between all groups. - To assess the safety of each dose of RTX - To assess the difference in medication use between all groups. - To assess whether baseline factors are predictive for obtaining DAS28-CRP low disease activity state at 6 months. - To estimate the cost effectiveness of both ultra-low RTX doses compared to the conventional low dose over the 6 months study period. - To compare the course of serum (anti-)RTX levels between all groups. ;Primary end point(s): Change in DAS28-CRP from baseline ; Timepoint(s) of evaluation of this end point: - 3 months follow-up - 6 months follow-up

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Baseline, 3 and 6 months follow-up; Secondary end point(s): - Disease activity (DAS28-CRP (TJC, SJC, CRP, VAS global patient), VAS global rheumatologist, VAS pain, ESR, OMERACT flare questionnaire) - Function (HAQ-DI) - Quality of life (EQ5D) - Adverse events - Medication use - Pharmacokinetics (RTX and anti-RTX levels) - Pharmacodynamics (serum free light chains, S100)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Baseline, 3 and 6 months follow-up; Secondary end point(s): - Disease activity (DAS28-CRP (TJC, SJC, CRP, VAS global patient), VAS global rheumatologist, VAS pain, ESR, OMERACT flare questionnaire) - Function (HAQ-DI) - Quality of life (EQ5D) - Adverse events - Medication use - Pharmacokinetics (RTX and anti-RTX levels) - Pharmacodynamics (serum free light chains, S100)

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Countries

Netherlands

Contacts

Public ContactJunior researcher

Sint Maartenskliniek

L.Verhoef@maartenskliniek.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026