EUCTR2012-003314-13-IT进行中（未招募）1 期
RItuximab for lupus Nephritis with remission as a Goal - RING
CLINIQUES UNIVERSITAIRES SAINT-LUC, UNIVERSITé CATHOLIQUE DE LOUVAIN, BRUXELLES, BELGIUM0 个研究点目标入组 194 人开始时间: 2021年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 194
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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.
研究者
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