EUCTR2006-000674-73-DE进行中（未招募）不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE
a Jolla Pharmaceutical Company0 个研究点目标入组 850 人开始时间: 2007年10月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 850
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
- •Each patient must meet all the following criteria in order to participate in
- •this trial:
- •2.1.1 Males or females aged between 12 and 70 years, inclusive; as required by local or national requirements, enrollment is limited to males or females aged between 18 and 70 years inclusive.
- •2.1.2 Female patients must be non-pregnant and non-lactating and have a negative urine pregnancy test result prior to enrollment in the study. Female patients of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method
- •which results in a failure rate of less than 1% per year, when used consistently and correctly, for example oral contraceptives, contraceptive patch, implants, injectables, some intrauterine contraceptive devices [IUDs], or sexual abstinence) during the
- •entire duration of the study. Males enrolled in the trial must have no plans to father a child during the course of the trial and agree to use adequate birth control methods.
- •2.1.3 Diagnosis of SLE for purposes of this trial utilizes the 1996 Revised Criteria for the Classification of SLE as defined by the American College of Rheumatology (ACR) where a diagnosis of SLE is established when >= 4 of the 11 criteria are met.
- •2.1.4 The patient must have had at least one documented episode of active SLE renal disease within 4 years prior to randomization as defined by at least one of the following 4 criteria:
- •a. Renal biopsy showing active lesions of SLE, Morphologic Classification of Lupus Nephritis defined by the World Health Organization (WHO) Class III, IV or V
- •b. Increase in serum creatinine:
- •- by greater than 0.3 mg/dL if previous value was less than 2.0 mg/dL
- •- by greater than 0.4 mg/dL if previous value was 2.0 mg/dL to 5.0 mg/dL
- •- AND either hematuria OR a C3, C4 or CH50 below lower limits of normal or at least 25% lower than a previous value.
- •Patients with hereditary C4 deficiency cannot qualify on the C4 or CH50 criterion alone.
- •c. Increase in proteinuria (measured by 24 hour urine protein or predicted 24 hour urine protein using either protein osmolality ratio or protein creatinine ratio):
- •- to greater than 1000 mg/24 hour if the previous value was < 200 mg/24 hour
- •- to greater than 2000 mg/24 hour if the previous value was >= 200 mg/24 hour and <= 1000 mg/24 hour
- •- to greater than 2 times the previous value if that value was > 1000 mg/24 hour
- •d. Use of cyclophosphamide to treat lupus nephritis that is documented in clinical or hospital records.
- •2.1.5 Elevated anti-dsDNA antibody concentration at pre-screening Visit 0 (>= 10 IU/mL) as measured by the Farr Assay at the regional central laboratory.
- •2.1.6 Ability to communicate meaningfully with the investigational staff, competence to give written informed consent, and ability to comply with the entire study procedure.
- •2.1.7 Duly executed, written, informed consent obtained from the patient, next of kin, or other legal representative. If required by local or national requirements, duly executed, written, informed consent obtained from the patient. Patients who are incarcerated in penal institutions or are committed to mental institutions may not consent to participate in this trial.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any of the following will exclude a patient from this trial:
- •2.2.1 Active SLE renal disease within the 3 months prior to Visit 3 as evidenced by:
- •Increase in serum creatinine:
- •- of greater than 0.3 mg/dL if previous value was less than 2.0 mg/dL
- •- of greater than 0.4 mg/dL if previous value was 2.0 mg/dL to 5.0 mg/dL
- •- AND either hematuria OR a C3, C4 or CH50 below lower limits of normal or at least 25% lower than a previous value
- •Reproducible increase in proteinuria (measured by 24 hour urine protein or predicted 24 hour urine protein using either protein/osmolality ratio or protein/creatinine ratio):
- •- to greater than 1000 mg/24 hour if the previous value was < 200 mg/24 hour
- •- to greater than 2000 mg/24 hour if the previous value was >= 200 mg/24 hour and <= 1000 mg/24 hour
- •- to greater than 2 times the previous value if that value was > 1000 mg/24 hour
- •Any other evidence of active renal disease.
- •2.2.2 An increase in the anti-dsDNA antibody concentration of more than 50% with an incremental increase of at least 50 IU/mL in antidsDNA antibody concentration by Farr Assay between the samples taken at Visit 0 and Visit 1 during the screening period.
- •2.2.3 Use of the following therapeutics:
- •- Prednisone > 20 mg/day within 1 month prior to Visit 1
- •- Any use of the following therapies or therapeutics within 2 months prior to randomization or 1 month prior to Visit 1:
- •- alkylating agents (e.g., cyclophosphamide)
- •- TNF inhibitors (e.g., etanercept, infliximab)
- •- cyclosporine
- •- plasmapheresis
- •- intravenous immunoglobulin
- •- prosorba column
- •- Use of mycophenolate mofetil that exceeds 1000 mg/day 1 month prior to Visit 1
- •- Any use of azathioprine that exceeds 100 mg/day within 1 month prior to Visit 1
- •- Any use of methotrexate that exceeds 10 mg/week within 1 month prior to Visit 1
- •- Any use of leflunomide that exceeds 10 mg/day within 1 month prior to Visit 1
- •- Any use of rituximab within 5 months prior to Visit 1
- •- Previous or concurrent medications and/or other therapies or devices that in the judgment of the Investigator are likely to confound the evaluation of the safety or efficacy of abetimus.
- •Examples include:
- •- Immunosuppressants or immunomodulatory drugs other than those therapies specifically noted above to include new immunomodulatory agents that may become commercially available during the course of the study
- •- Drugs that have the potential to induce SLE (e.g.,isoniazid, phenytoin, hydralazine, procainamide, etc.)
- •- Radiation therapy within the last year.
- •- If the Investigator has any question concerning a particular medication, he/she should discuss this with the Medical Monitor prior to randomization.
- •- Patient has received any investigational new drug or device within 30 days prior to screening or 5 half-lives of the agent (whichever is longer), or any investigational new drug with a long-term effect. (e.g., ocrelizumab, tacrolimus).
- •- Prior participation in study LJP 394-90-14.
- •2.2.4 Exclusionary laboratory values:
- •- leukocyte count < 2,000 cells/mm3
- •- platelet count < 50,000 cells/mm3
- •- hemoglobin < 8.5 gm/dL
- •- serum hepatic transaminases >= 3X the upper limit of normal
- •- serum creatinine > 3.5 mg/dL within the 2 months prior to randomization
- •2.2.5 Malignant disease or immunodeficiency syndrome within 5 years, except patients with basal cell or squamous cell carcinoma of the skin with complete excision and clean borders.
- •2.2.6 Evidence of current abuse of drugs or alcohol.
- •2.2.7 History of poor procedural compliance in
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