A RANDOMIZED, DOUBLE-BLIND PHASE 2B STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A 623 ADMINISTRATION IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Anthera Pharmaceuticals, Inc.,0 个研究点目标入组 55 人开始时间: 2010年11月30日最近更新: 2023年9月4日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 55

研究概览入排标准研究者记录与标识符相似试验

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

•Diagnosis of SLE according to the guidelines of the American College of Rheumatology.
•Standard care treatment for at least 2 months and a stable dosing regimen for> 30 days prior to randomization (standard care medications include NSAIDs, antimalarial drugs, corticosteroids, methotrexate, azathioprine, leflunomide and mofetil [<3 g / day]).
•Active SLE disease, defined according to a SELENA-SLEDAI score of> 6 in the selection.
•Serologically active as defined by the antinuclear antibody (ANA)> 1:80 (IFA titer using the Hep2 cell line) and / or double stranded anti-DNA (anti-ds DNA)> 30 lU / ml at the time of selection .
•Age> 18 years.
•They are receiving a stable dose of prednisone between 7.5 mg and 40 mg per day for> 30 days. They may be at doses <7.5 mg / day or without prednisone, if they receive at least one other medication for SLE (refer to the medications listed in Inclusion 2 above).

排除标准

•A disorder (including psychiatric), clinically significant condition or disease (other than a diagnosis of SLE) that would interfere with the evaluation, termination and / or study procedures according to the investigator´s criteria. This includes any comorbidity such as the presence of congestive heart failure, angina, chronic obstructive disease and lung disease.
•Active vasculitis (defined as gangrene or acute ischemic infarction), active central nervous system lupus (CNS), active lupus nephritis, uncontrolled hypertension (> 160/90 mm Hg) or uncontrolled diabetes (according to the clinical criteria of the researcher) .
•Have a positive test for human immunodeficiency virus (HIV) and / or a positive test at the selection visit for hepatitis B surface antigen or hepatitis C virus.
•Liver disease (alanine aminotransferase [ALT] or serum aspartate aminotransferase [AST]> 3 times the upper limit of normal [ULN]).
•Anemia (Hgb <8 g / dl), neutropenia (<1500 cells / ul) or thrombocytopenia (<50,000 cells / ul). If the condition is considered to be due to SLE, the subject may be included after discussing it with the medical monitor.
•Malignant neoplasm in the last 5 years (apart from squamous cell carcinoma or basal cell carcinoma of the skin that has been removed and considered cured).
•Active infection that requires hospitalization or treatment with parenteral antibiotics in the last 60 days or a history of repeated viral infections (an infection is defined as more than 2 episodes in the 2 years prior to selection).
•History of active tuberculosis or a history of positive screening test for latent Mycobacterium tuberculosis infection.
•Any previous administration of the A-623.
•Participation in the treatment group with active substance in any phase 2 or phase 3 clinical trial for a molecule that is primarily directed to the B lymphocyte pathway (for example, bellmumab, TACi-lg) in the last 18 months.
•Prior administration of any 8 lymphocyte reduction therapy (such as anti-CD20 or anti-CD22 molecules) in the last 18 months.
•Administration of cyclophosphamide, prednisone in high doses, cyclosporine, anti-TNFa therapies, transfusion, plasma exchange or plasma exchange, IV immunoglobulin or live vaccines
•Women who are breastfeeding, pregnant or trying to get pregnant during the time of the study, or who have a positive serum pregnancy test at baseline (if the subject is a woman with the possibility of pregnancy). Subjects with reproductive potential will require using a reliable method of birth control during the study and for 3 months after the termination of therapy. A reliable method of birth control is defined as one of the following: oral or injectable contraceptives, intrauterine device, contraceptive implants, tubal ligation, hysterectomy or a double barrier method (diaphragm with foam or spermicidal gel, or a condom) or vasectomy Menopause is defined as the absence of menstrual cycles for at least 12 months.

研究者

发起方

Anthera Pharmaceuticals, Inc.,

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