EUCTR2012-003314-13-BE进行中（未招募）不适用
RING – RItuximab for lupus Nephritis with remissionas a Goal, an investigator-initiated randomized international open multicentric study - RING
Cliniques Universitaires Saint Luc, Université catholique de Louvain0 个研究点目标入组 194 人开始时间: 2012年8月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Inclusion criteria (at screening)
- •All the following inclusion criteria are to be met :
- •1. 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) (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; iv): AZA for at least 6 months
- •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, 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: 15
- •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 0
排除标准
- •Exclusion criteria (at screening, except exclusion criteria 1 at randomization).
- •Any of the following :
- •1. 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
相似试验
进行中（未招募）
不适用
RING – RItuximab for lupus Nephritis with remissionas a Goal, an investigator-initiated randomized international open multicentric studyupus NephritisMedDRA version: 14.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2012-003314-13-CZCliniques Universitaires Saint Luc, Université catholique de Louvain194
进行中（未招募）
不适用
RING – RItuximab for lupus Nephritis with remissionas a Goal, an investigator-initiated randomized international open multicentric studyEUCTR2012-003314-13-SECliniques Universitaires Saint Luc, Université catholique de Louvain194
进行中（未招募）
1 期
RING – RItuximab for lupus Nephritis with remissionas a Goal, an investigator-initiated randomized international open multicentric studyupus NephritisMedDRA version: 17.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2012-003314-13-PTCliniques Universitaires Saint Luc, Université catholique de Louvain194
进行中（未招募）
1 期
RING – RItuximab for lupus Nephritis with remissionas a Goal, an investigator-initiated randomized international openmulticentric studyupus NephritisMedDRA version: 18.0Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersLupus NephritisEUCTR2012-003314-13-DECliniques Universitaires Saint Luc, Université catholique de Louvain, Bruxelles194
进行中（未招募）
不适用
RING ? RItuximab for lupus Nephritis with remissionas a Goal, an investigator-initiated randomized international open multicentric studyupus NephritisMedDRA version: 18.0Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2012-003314-13-ESCliniques Universitaires Saint Luc, Université catholique de Louvain194