PER-037-07已完成未知
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- 0 至 0（—）
入选标准
- •1. Be at least 18 years of age.
- •2. Have a clinical diagnosis of SLE according to the criteria of the American College of Rheumatology.
- •3. Have active SLE disease defined according to a SELENA SLEDAI Rating ≥ 6 in the evaluation.
- •4. Have unequivocally positive antinuclear antibody (ANA) results at 2 independent time points.
- •5. Have a stable treatment regimen for SLE.
- •6. Subjects with angiotensin-channel antihypertensive drugs should be in stable regimen for a period of at least 30 days before Day 0.
- •7. Subjects with HMG CoA reductase inhibitors should be in stable regimen for a period of at least 30 days before Day 0.
- •8. A female subject is eligible to enter the study if: A) She is not pregnant or breastfeeding; B) Does not have pregnancy potential or C) Is of childbearing age and has a negative pregnancy test in the evaluation, and must use 1 of the acceptable contraceptive methods.
- •9. A male subject is eligible to enter the study if they agree to use a contraceptive method during the study and for 3 months after the last dose of the study medication.
- •10. Have the ability to understand the requirements of the study, provide written informed consent and adhere to the procedures of the study protocol.
排除标准
- •1, Having received treatment with any treatment directed to B lymphocytes at any time.
- •2. Have received any of the following, in the 364 days prior to Day 0: a) Abatacept. b) A biological agent in research other than treatment directed to B lymphocytes.
- •3. Have required 3 or more cycles of systemic corticosteroids for concomitant conditions in the 364 days prior to Day 0.
- •4. Having received intravenous cyclophosphamide (IV) in the 180 days prior to Day 0.
- •5. Have received any of the following in the 90 days prior to Day 0: a) Anti-TNF treatment. b) Interleukin-1 receptor antagonists. c) Intravenous immunoglobulin (IVIG). d) High doses of prednisone. e) Plasmapheresis.
- •6. Have received any of the following, in the 60 days prior to Day 0: a) A non-biological agent in research. b) Any new immunosuppressive / immunomodulatory, antimalarial agent. NSAID, inhibitor of HMG CoA reductase or antihypertensive angiotensin. c) Any steroid injection.
- •7. Have received any of the following, within 30 days prior to Day 0: a) A live virus vaccine. b) A change in the dose of a corticosteroid, another immunosuppressive / immunomodulatory agent.
- •antimalarial, NSAID, inhibitor of HMG CoA reductase or antihypertensive of the angiotensin pathway.
- •8. Have severe lupus kidney disease, or have active nephritis, or have required hemodialysis or prednisone at high doses in the 90 days prior to Day 0.
- •9. Have active lupus with involvement of the central nervous system (CNS) that requires therapeutic intervention in the 60 days prior to Day 0.
- •10. Having a history of a major organ transplant or hematopoietic stem cell transplant / bone marrow.
- •11. Have clinical evidence of significantly unstable or uncontrolled acute or chronic diseases not due to SLE.
- •12. Having a scheduled surgical procedure or history of any other medical illness, laboratory abnormality, or condition, which makes the subject unsuitable for the study.
- •13. Having a history of malignancy in the last 5 years.
- •14. Have required treatment of acute or chronic infections, namely: a) Currently with any suppressive treatment for a chronic infection. b) Hospitalization for treatment of infection in the 60 days prior to Day 0. c) Use of parenteral antibiotics in the 60 days prior to Day 0.
- •15. Currently have drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence in the 364 days prior to Day 0.
- •16. Have a positive test for antibody to HIV-1, hepatitis B surface antigen or antibody to hepatitis C.
- •17. Have an IgA deficiency.
- •18. Have a laboratory abnormality Grade 3 or higher.
- •19. Having a history of an anaphylactic reaction to the parenteral administration of contrast media, human or murine proteins or monoclonal antibodies.
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