RING - Rituximab for Lupus Nephritis With Remission as a Goal (RING)
Lupus Nephritis
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring Lupus Nephritis, Rituximab
Eligibility Criteria
Inclusion Criteria:
All the following inclusion criteria are to be met :
- SLE, according to ACR and/or SLICC (Arthritis Rheum 2012; May 2; doi: 10.1002/art.34473) criteria ;
- Age ≥15y (except if local ethics committee imposes ≥18y) ;
- ISN/RPS 2003 Class III (A or A/C), IV (A or A/C ; S or G) or V lupus GN confirmed on renal biopsy performed within 24 months before screening ;
Having received one out of four following immunosuppressive regimens:
i): Euro-Lupus (EL) intravenous (IV) cyclophosphamide (CY) (6x 500 mg q2w) followed by AZA/MMF for 3 months ; ii): NIH IVCY for 6M (6 monthly pulses) followed by AZA/MMF for 3 months ; iii): MMF for at least 6 months at a dose of 2g/day (or the maximal tolerated dose; iv): AZA for at least 6 months at a dose of 2 mg/kg/day (or the maximal toerated dose).
All patients should be on AZA or MMF at screening. In all regimens, MMF can be replaced by enteric-coated mycophenolic acid (eMPA) ;
- If on GC, being on maximum 10 mg equivalent prednisolone/d at screening (for at least 2 weeks) ;
- uP/C ratio ≥1 (expressed in mg/mg) measured in a 24-h urine collection, confirmed at randomization (w-2) ;
- Contraception (any type ; sexual abstinence is an alternative to contraception in paediatric patients) ;
- Signed informed consent (drafted according to local practice and approved by the local ethics committee).
Exclusion Criteria:
Any of the following :
- Recent or ongoing renal flare defined as either i) : fall in estimated glomerular filtration rate (eGFR ; MDRD) ≥25% within 3 month prior to screening or between screening and randomization ; or ii) : increase in urine protein by ≥100% to >3.5g/d compared to previous assessment ;
- 24-h proteinuria decline >50% over previous 6 months ;
- Treatment with ≥10 mg equivalent prednisolone/d in the last 2 weeks before screening ;
- Pregnancy or breast-feeding ;
- Anticipated non-compliance with the protocol ;
- History of malignancy (except non-melanoma skin and cervical intraepithelial cancer) ;
- Previous treatment with RTX (whenever) and previous treatment with another biologic agent within the last 6 months ;
- HIV infection ;
- Active HBV/HCV/TB infection ;
- Severe liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic or psychiatric disturbances, that would contraindicate inclusion in the protocol, as judged by the clinician.
Sites / Locations
- Cliniques Universitaires Saint LucRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
RTX group
Control group
Subjects will receive a RTX infusion (1g) at w0, w2, w24, w48 and w72.
Subjects will not receive RTX infusions and will be followed in standard of care