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临床试验/EUCTR2012-003314-13-DE
EUCTR2012-003314-13-DE进行中（未招募）1 期

RING – RItuximab for lupus Nephritis with remissionas a Goal, an investigator-initiated randomized international openmulticentric study - RING

Cliniques Universitaires Saint Luc, Université catholique de Louvain, Bruxelles0 个研究点目标入组 194 人开始时间: 2015年6月11日最近更新:
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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
研究概览入排标准研究者记录与标识符相似试验

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) ;(minors will be included as LN is not uncommon in female teenagers. The disease can be very refractory to SOC)
  • •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
  • •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) ;(minors will be included as LN is not uncommon in female teenagers. The disease can be very refractory to SOC)
  • •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).
  • 另有 34 项未显示

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 ;(excluded at screening by test)
  • •9. Active HBV/HCV/TB infection (excluded at screening by test);
  • •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
  • •11. history of severe allergic or anaphylactic reaction to humanized or monoclonal antibodies or murine monoclonal antibodies, or known hypersensitivity to any component of RTX
  • •12. active infections requiring hospitalizations or treatment with IV anti-infectives within 4 weeks prior screening
  • •13.treatment with a life or attenuated vaccine within 28 days prior to randomization
  • •14. grade 3 laboratoy abnormalities, dealing with haematology and liver tests, will be excluded, unless these are lupus-related
  • •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 ;(excluded at screening by test)
  • •9. Active HBV/HCV/TB infection (excluded at screening by test);
  • •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
  • •11. history of severe allergic or anaphylactic reaction to humanized or monoclonal antibodies or murine monoclonal antibodies, or known hypersensitivity to any component of RTX
  • •12. active infections requiring hospitalizations or treatment with IV anti-infectives within 4 weeks prior screening
  • •13.treatment with a life or attenuated vaccine within 28 days prior to randomization
  • •14. grade 3 laboratoy abnormalities, dealing with haematology and liver tests, will be excluded, unless these are lupus-related
  • 另有 25 项未显示

研究者

发起方
Cliniques Universitaires Saint Luc, Université catholique de Louvain, Bruxelles

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