RhEumatoid arthritis REtreatment with ultra-low dose Rituximab: Disease Outcome after Dose Optimizatio

Phase 4

Completed

Conditions: chronic inflammation of the joints
Rheumatoid arthritis
10003816
10023213

Registration Number: NL-OMON47117

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

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<2.9 (DAS28-BSE <3.2) or judgement of low disease activity by a rheumatologist) AND a current DAS28-CRP *3.5 (DAS28-BSE*3.8).
- Patient informed consent, *18 years old and mentally competent
- Ability to measure the outcome of the study in this patient (e.g. life expectancy * 6 months, no planned relocation out of reach of study centre)
- Ability to read and communicate well in Dutch

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease activity measured with the DAS28-CRP at baseline, 3 and 6 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Baseline characteristics: demographics, disease characteristics, treatment<br /><br>characteristics, joint damage, patient and rheumatologist expectations of lower<br /><br>dose.<br /><br>- Functioning: measured with HAQ-DI at baseline, 3 and 6 months<br /><br>- Quality of life: measured with EuroQolEQ5D-5L at baseline, 3 and 6 months<br /><br>- Adverse events: occurrence of adverse events during study period.<br /><br>- Medication use: use of DMARDs, corticosteroids, NSAIDs during study period<br /><br>- Pharmacokinetics: serum RTX, serum anti-RTX at four time points: before<br /><br>infusion, after infusion, after 3 and after 6 months.<br /><br>- Pharmacodynamics: To be able to study the pharmacodynamics of RTX in patients<br /><br>and possible predictors of response, we will analyze at baseline, 3 months and<br /><br>6 months: CD19+ B-cell count (baseline only), serum free light chains, S100A8/9.<br /><br>- Costs<br /><br>- Process evaluation: study integrity</p><br>