EUCTR2009-011245-55-DK进行中（未招募）不适用
An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16. Protocol Amendment 1 dated 2009-10-13. Protocol Amendment 2 dated 2009-12-02
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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.Age > 18 years at the time of signing the informed consent form
- •2.Fulfil at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR).
- •3.Present with active SLE disease with at least one of the following symptoms:
- •i) Arthritis – > 2 joints with pain and signs of inflammation (i.e. tenderness, swelling, or effusion)
- •ii) Inflammatory-type skin rash
- •iii) Oral ulcers
- •4.Laboratory values as follows
- •- Hemoglobin = 100 g/L
- •- Absolute neutrophil count = 1.0 x 109/L
- •- Total bilirubin = 1.5 x upper limit of normal (ULN)
- •- AST (SGOT) / ALT (SGPT) = 2.5 x ULN
- •5.Ability to take and retain oral medication
- •6.Ability to sign and date a written informed consent prior to entering the study
- •7.Willingness and ability to comply with the protocol for the duration of the study
- •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
- •1.Active severe SLE flare with central nervous system (CNS) manifestations, active renal lupus, systemic vasculitis, active pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol.
- •2.Severe renal impairment (estimated or measured GFR <50%)
- •3.Oral treatment with corticosteroids (>15 mg/day prednisolone or equivalent) or changes in corticosteroid dosing within 30 days prior to the first dose of study medication. This also includes intraarticular steroid injections or topical treatment for SLE symptoms. Inhaled or topical steroids may be given for reasons other than SLE disease activity (such as asthma, contact dermatitis) as clinically indicated.
- •4.Intravenous corticosteroids within 3 months prior to the first dose of study medication.
- •5.Intravenous cyclophosphamide within 6 months prior to the first dose of study medication.
- •6.Treatment with anti-rheumatic/immunosuppressive drugs within 3 months prior to first dose of study medication, other than the following medications at stable doses: methotrexate (=25 mg/week), azathioprine (=2.5 mg/kg/day), hydroxychloroquine and mycophenolate mofetil (=3000 mg/day).
- •7.B-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication.
- •8.Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication.
- •9.History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia.
- •10.Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds
- •11.History of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome)
- •12.Treatment with concomitant medications that prolong the QT interval.
- •13.History of, or current, ischemic CNS disease.
- •14.Current malignancy. A 5-year cancer-free period is required with the exception of skin basal or squamous cell carcinoma or cervical cancer in situ that has been excised.
- •15.Current severe infection
- •16.Positive result on screening for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV) antibodies.
- •17.Drug abuse.
- •18.Major surgery within 3 weeks prior to study entry.
- •19.Known or suspected hypersensitivity to ABR-215757 or excipients.
- •20.Female subject of child-bearing potential who is not using a medically accepted safe method of contraception. All female subjects of child-bearing potential must have a negative urine pregnancy test at the Screening and Baseline Visits. As interaction studies between ABR-215757 and oral contraceptives have not yet been performed, women using the contraceptive pill must also use a complementary contraceptive device, ie barrier method, during the treatment period and for at least 1 month thereafter.
- •21.Female subject of child-bearing potential who is pregnant or lactating.
- •22.Simultaneous participation or participation within 4 months or 5 half lives (whichever is longer) prior to study entry in any other study involving investigational drugs or other experimental therapy.
- •23.Other significant, unstable medical disease not related to SLE that in the investigator’s opinion would confound the study result or put the patient at risk.
- •24.Patient
研究者
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