EUCTR2005-001391-12-ES进行中（未招募）1 期
A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE
TEVA Pharmaceutical Industries, Ltd.0 个研究点目标入组 260 人开始时间: 2005年7月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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. Subjects must be willing and able to give written informed consent prior to entering the study.
- •2. Subjects must be between the ages of 18 and 65 years (inclusive).
- •3. SLE patients who fulfilled at least 4 classification criteria (1997 revised) of the American College of Rheumatology for SLE by the time of screening visit.
- •4. SLE patients with moderate, active disease, who score between 6 and 12 (inclusive) on SLE disease activity index 2K (SLEDAI 2K) at screening visit and re-confirmed before randomization.
- •5. Subjects treated with chronic concomitant medication must be taking a stable dose of SLE medications for at least 4 weeks before randomization.
- •6. Women of child-bearing potential must practice a medically acceptable method of contraception.
- •7. Subjects must understand the requirements of the study and agree to comply with the study protocol.
- •Are the trial subjects under 18? no
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Women who are pregnant, breast-feeding or intending to become pregnant within 6 months of last dose of study drug.
- •2. Any condition which the investigator feels may interfere with participation in the study, including alcohol and/or drug abuse.
- •3. Subjects having a history of chronic infection that has been active within 3 months prior to randomization or latent tuberculosis.
- •4. Subjects with hemoglobin < 8.5 gm/dl or neutrophils < 1,000/mm3, or platelets
- •5. Subjects with urine protein to creatinine ratio (at screening visit) of either > 0.75 or unstable urine protein to creatinine ratio between 0.5 and 0.75 and/or hematuria (lupus related) and/or pyuria (lupus related) and/or with cellular casts (RBC or WBC).
- •6. Active, CNS lupus manifestations (including lupus headache) as defined in SLEDAI 2K descriptors during the 3 months prior to randomization.
- •7. Subjects with a history of immunodeficiency syndrome or malignancy, except subjects with cervical cancer, basal cell or squamous cell carcinoma of the skin more than 5 years prior to screening visit.
- •8. Subjects who presented a positive laboratory test for Hepatitis B surface antigen (HbsAg), or HCV antibody.
- •9. Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization, or who are scheduled to receive another investigational drug during the course of the study or within 4 months following the last dose of the study.
- •10. Subjects receiving daily treatment of 40 mg or more of prednisone / prednisolone a day or subjects treated with other steroids or regimens at screening visit.
- •11. Subjects treated with any cytotoxic agents (e.g. cyclophosphamide, mycophenolate mofetil, cyclosporin, leflunomide, chlorambucil) or any immunosuppressive agents or immunomodulators not mentioned above (e.g. Remicade, Enbrel), or IV Ig or plasmapheresis in the 3 months prior to randomization and/or azathioprine and methotrexate in the 4 weeks prior to randomization.
- •12. Diagnosis of drug-induced lupus [at any time in the past].
- •13. History of allergy to SBECD (sulfobutyl ether beta-cyclodextrin sodium, Captisol®) or other cyclodextrins.
研究者
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