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临床试验/EUCTR2005-004575-37-GB
EUCTR2005-004575-37-GB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 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + 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: 2008年10月8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 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
  • •must be removed prior to randomization (Day 1 treatment). Subjects with carcinoma
  • •in situ, treated with definitive surgical intervention, are allowed.
  • •15) Subjects with any serious bacterial infection within the last 3 months, unless treated
  • •and 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-interstitial

研究者

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