RItuximab for lupus Nephritis

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 194

Inclusion Criteria

SLE, according to ACR and/or SLICC (Arthritis Rheum 2012; May 2;
doi: 10.1002/art.34473) criteria ;
2. Age =15y (except if local ethics committee imposes =18y) ;
3. 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 ;
4. Having received one out of four following immunosuppressive regimens:
i. Euro-Lupus (EL) intravenous (IV) cyclophosphamide (CY) (6
x 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 tolerated dose)
All patients should be on AZA or MMF at screening. In all regimens,
MMF can be replaced by enteric-coated mycophenolic acid (eMPA) ;
5. If on GC, being on maximum 10 mg equivalent prednisolone/d at
screening (for at least 2 weeks) ;
6. uP/C ratio =1 (expressed in mg/mg) measured in a 24-h urine collection,
Version 2.0 – February 6, 2013
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confirmed at randomization (w-2) ;
7. Contraception (any type ; sexual abstinence is an alternative to
contraception in paediatric patients) ;
8. Signed informed consent (drafted according to local practice and approved
by the local ethics committee).
Are the trial subjects under 18? yes
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 179
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 ;
2. 24-h proteinuria decline >50% over previous 6 months ;
3. Treatment with =10 mg equivalent prednisolone/d in the last 2 weeks
before screening ;
4. Pregnancy or breast-feeding ;
5. Anticipated non-compliance with the protocol ;
6. History of malignancy (except non-melanoma skin and cervical
intraepithelial cancer) ;
7. Previous treatment with RTX (whenever) and previous treatment with
another biologic agent within the last 6 months ;
8. HIV infection ;
9. Active HBV/HCV/TB infection ;
10. Severe liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine,
neurologic, haematologic or psychiatric disturbances, that would
contraindicate inclusion in the protocol, as judged by the clinician.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method