PER-044-13已完成未知
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 52-WEEK STUDY TO ASSESS ADVERSE EVENTS OF SPECIAL INTEREST IN ADULTS WITH ACTIVE, AUTOANTIBODY-POSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS RECEIVING BELIMUMAB
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 100（—）
- 性别
- All
入选标准
- •1. Males or females ≥ 18 years.
- •2. Have a diagnosis of SLE, refer to ACR revised criteria for the classification of SLE
- •(Appendix 1) as a guide for diagnosis of SLE.
- •3. Active, autoantibody positive SLE (autoantibody positive is defined as the presence of
- •ANA or anti-dsDNA antibodies).
- •4. Are on a SLE treatment regimen consisting of any of the following medications (alone or
- •in combination):
- •Corticosteroids
- •Other immunomodulatory agents including methotrexate, azathioprine, leflunomide,
- •mycophenolate (including mycophenolate mofetil, mycophenolate mofetil
- •hydrochloride, and mycophenolate sodium), calcineurin inhibitors (eg, tacrolimus,
- •cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide.
- •Anti-malarials [eg, hydroxychloroquine, chloroquine, quinacrine (mepacrine)]
- •5. A female subject is eligible to enter the study if she is:
- •Not pregnant or nursing;
- •Of non-childbearing potential (ie, women who had a hysterectomy, are
- •postmenopausal which is defined as 1 year without menses, have both ovaries
- •surgically removed or have current documented tubal ligation or any other permanent
- •method of female sterilization); or
- •Of childbearing potential (ie, women with functional ovaries and no documented
- •impairment of oviductal or uterine function that would cause sterility). This category
- •includes women with oligomenorrhoea [even severe], women who are perimenopausal
- •or have just begun to menstruate. These women must have a negative urine pregnancy
- •test at screening, and agree to 1 of the following:
- •-Complete abstinence from intercourse from 2 weeks prior to administration of the
- •1st dose of study agent until 16 weeks after the last dose of study agent; or
- •- Consistent and correct use of 1 of the following acceptable methods of birth
- •control for 1 month prior to the start of the study agent, during the study and
- •16 weeks after the last dose of study agent:
- •◦ Implants of levonorgestrel or etonogestrel;
- •◦ Injectable progesterone;
- •◦ Any intrauterine device (IUD) with a documented failure rate of less than 1%
- •◦ Oral contraceptives (either combined or progesterone only);
- •◦ Ethinyl estradiol/Etonogestrel vaginal ring;
- •◦ Double barrier method: condom and occlusive cap (diaphragm or cervical/vault
- •caps) with spermicidal foam/gel/film/cream/suppository;
- •◦ Transdermal contraceptive patch;
- •◦ Male partner who is sterile prior to the female subject’s entry into the study
- •and is the sole sexual partner for the female subject.
- •Note: MMF and other forms of mycophenolate affect the metabolism of oral
- •contraceptives and may reduce their effectiveness. As such, women receiving
- •mycophenolate who are using oral contraceptives for birth control should employ
- •an additional method (eg, barrier method).
- •6. Have the ability to understand the requirements of the study, provide written informed
- •consent, including consent for the use and disclosure of research-related health
- •information, and comply with the study data collection procedures.
排除标准
- •1. Have received any prior treatment with belimumab, either as a marketed product or as an
- •investigational agent.
- •2. Have received treatment with B cell targeted therapy (eg, rituximab, other anti-CD20
- •agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion
- •protein [BR3], TACI-Fc, anti-BAFF [LY2127399]) within 364 days of Day 0.
- •3. Have received any of the following within 90 days of Day 0:
- •Any biologic agent (eg, adalimumab, etanercept, infliximab, anakinra) other than
- •B cell targeted therapy (see Exclusion Criterion 2).
- •Plasmapheresis.
- •4. Have received any of the following within 60 days of Day 0:
- •A non-biologic investigational agent.
- •5. Have received any of the following within 30 days of Day 0:
- •A live vaccine.
- •6. Have a history of malignant neoplasm within the last 5 years, except for adequately treated
- •cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
- •7. Have required management of acute or chronic infections, as follows:
- •Currently on any suppressive therapy for a chronic infection (such as tuberculosis,
- •pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical
- •mycobacteria).
- •Hospitalization for treatment of infection within 60 days of Day 0.
- •Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or
- •anti-parasitic agents) within 60 days of Day 0.
- •8. Have severe lupus kidney disease (defined by proteinuria > 6 g/24 hour or equivalent
- •using spot urine protein to creatinine ratio, or serum creatinine > 2.5 mg/dL), or have
- •severe active nephritis requiring acute therapy, or have required hemodialysis or high-dose
- •prednisone or equivalent (> 100 mg/day) within 90 days of Day 0.
- •9. Have severe active central nervous system (CNS) lupus (including seizures, psychosis,
- •organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis)
- •requiring therapeutic intervention.
- •10. Known HIV infection.
- •11. Current or history of hepatitis B or hepatitis C infection
研究者
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