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临床试验/EUCTR2005-004575-37-BE
EUCTR2005-004575-37-BE进行中（未招募）1 期

A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).

Bristol-Myers Squibb International Corporation0 个研究点目标入组 460 人开始时间: 2007年6月15日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
460
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

  • •1) Signed written informed consent
  • •2) SLE as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus (Protocol Appendix 1), either sequentially or coincidentally. The 4 criteria need not be present at the time of study entry.
  • •3) Biopsy within 12 months prior to screening visit indicating active proliferative lupus
  • •glomerulonephritis ISN/RPS 2003 classification Class III or IV [excluding Class III
  • •(C), IV-S (C) and IV-G (C)] or WHO 1982 Classification Class III or IV (excluding
  • •Class III c, IVd). NOTE: If the biopsy was performed > 3 months but = 12 months
  • •prior to screening visit, at least 1 of the following 3 serologies (performed locally)
  • •must be abnormal prior to screening visit:
  • •Complement (C3 or C4) level below normal range
  • •Anti-dsDNA > upper limit of normal range
  • •4) Active renal disease at the screening visit, as defined by:
  • •urinary protein/creatinine ratio = 50 mg/mmol AND an active urinary sediment as defined by at least one of the following 3 criteria:
  • •a) > 5 RBC/hpf OR
  • •b) > 8 WBC/hpf (with no evidence of a urinary tract infection) OR
  • •c) cylindruria
  • •Subjects not meeting all the criteria but meeting all other inclusion and exclusion
  • •criteria may be re-screened for urinary sediment ONCE within 2 weeks of the original
  • •screening visit in consultation with the BMS Medical Monitor.
  • •NOTE: Subjects prior to consenting who were treated with systemic
  • •glucocorticosteroid treatment (at least 30 mg or 0.5 mg/kg of prednisone-equivalent
  • •or intravenous pulse, as per local standards) during the current episode of lupus
  • •nephritis AND had documented abnormal (> ULN) urinary sediment (as per local
  • •laboratory) during the current episode of lupus nephritis AND have persisting
  • •proteinuria (urinary protein/creatinine ratio = 50 mg/mmol) present at screening visit,
  • •will be considered to have met this inclusion criterion.
  • •5) Serum creatinine = 3 mg/dL (i.e., = 265 micromol/L). (Subjects not meeting this criterion but meeting all other inclusion and exclusion criteria may be re-screened for serum creatinine ONCE
  • •within 2 weeks of the original screening visit in consultation with the BMS Medical
  • •6) Men and women, at least 16 years of age.
  • •7) Eligibility of subjects for entry into the study is based on their current renal disease activity which may represent:
  • •a) The first manifestation of their SLE.
  • •b) The first renal manifestation of SLE.
  • •c) Recent worsening of glomerulonephritis that had been diagnosed previously.
  • •d) Persistence of renal disease despite current therapies, including MMF and/or
  • •glucocorticosteroids, as long as the medications used are permitted by protocol.
  • •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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •1)WOCBP unwilling or unable to use an acceptable method to avoid pregnancy for entire study period & up to 10 weeks after study
  • •2)WOCBP using a prohibited contraceptive method (there are none)
  • •3)pregnant or breastfeeding women
  • •4)Women with positive pregnancy test on enrollment or prior to study drug
  • •administration
  • •5)Males unwilling or unable to follow recommendations for use of contraception
  • •specified by the manufacturer of any protocol-permitted disease sparing medication
  • •(biologic or non-biologic) being used during study
  • •6)Subjects with a rise of serum creatinine of = 1 mg/dL within 1 month prior to screening visit
  • •7)Subjects with drug-induced SLE, as opposed to idiopathic SLE.
  • •8)Subjects with severe, unstable &/or progressive CNS lupus (screening MRI or other imaging of the brain is not required to rule-out CNS disease in subjects who have no clinical features suggesting active CNS disease)
  • •9)Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; RA, MS)
  • •10)Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,
  • •hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological,
  • •endocrine, or cerebral disease. Concomitant medical conditions that, in the opinion of
  • •the Investigator, might place the subject at unacceptable risk for participation in this
  • •11)Concomitant illness that in the opinion of the investigator, is likely to require
  • •additional high dose oral glucocorticosteroid therapy (i.e. > 45 mg per day) during study, (e.g.; asthma)
  • •12)Female subjects who have had breast cancer screening study suspicious for malignancy, & in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations
  • •13) Female subjects who have evidence of cervical dysplasia that require definitive
  • •therapy according to local guidelines or the Consensus Guidelines and have not been
  • •properly treated (refer to Protocol Section 7.3.2.4).
  • •14) Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers mst be removed prior to randomization (Day 1 treatment). Subjects with carcinoma n situ, treated with definitive surgical intervention, are allowed.
  • •15) Subjects with any serious bacterial infection within the last 3 months, unless treated nd resolved with antibiotics, or any chronic bacterial infection (such as chronic
  • •pyelonephritis, osteomyelitis and bronchiectasis).
  • •16) Subjects at risk for tuberculosis. Specifically, subjects with:
  • •a) Current clinical, radiographic or laboratory evidence of active TB.
  • •b) A history of active TB within the last 3 years even if it was treated.
  • •c) A history of active TB greater than 3 years ago unless there is documentation that
  • •the prior anti-TB treatment was appropriate in duration and type.
  • •d) Latent TB which has not been successfully treated.
  • •17) Subjects with herpes zoster that resolved less than 2 months prior to screening visit.
  • •18) Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection.
  • •19) Subjects who are renal transplant recipients or candidates.
  • •20) Subjects who are diagnosed as end-stage renal disease.
  • •21) Subjects with persistent non-lupus related pyuria.
  • •22) Subjects with a degree of tubulo-inters

研究者

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