A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND

A JOLLA PHARMACEUTICAL COMPANY0 个研究点目标入组 730 人开始时间: 2008年3月20日最近更新: 2012年3月19日

研究概览

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•Males or females between 12 and 70 years old inclusive. Female patients must have a negative pregnancy test. Diagnii'osis of SLE established when > or equal 4 of the 11 criteria are met based on the classification of the American College of Rheumatology. At least one documented episode of active SLE renal disease within 4 years prior to randomization. Elevated anti dsDNA antibody concentration at pre-screening visit as measured by Farr assay.
•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

•Active SLE renal disease in the 3 months prior to randomization. An increase in the anti sdDNA antibody concentration of more than 50% of the former sample. Use of the following therapeutics: prednisone, alkylating agents, TNF inhibitors, cyclosporine, plasmapheresis, intravenous immnoglobulin, prosorba column, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, rituximab. laboratory values: leukocyte count < 2000 cells/mm3, platelet count < 50000 cells/mm3, hemoglobin < 8.5 gr/dl transaminases > 3X the upper limit of normal, serum creatinine > 3.5 mg/dL. Immunodeficiency syndrome within 5 years. Evidence of current abuse of drugs or alcohol. Serious cardiac disease. Patients has previously undergone organ transplantation.

发起方

A JOLLA PHARMACEUTICAL COMPANY