An open randomized and comparative study on the efficacy and safety of additional treatment of subcutaneous immunoglobulin (Subcuvia) during cessation of Prednisolon in patients with active systemic lupus erythematosus (SLE)

Department of Rheumatology,University hospital,Lund0 个研究点开始时间: 2007年2月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•·Patients with SLE during active illness phase defined as SLEDAI 2K 4 or higher
•·Patients with skin or joint engagement and/or serositis, low-grade hemolytic anemia and vasculitis.
•·Patients aged > 18 years and < 70 years, of either gender
•·Signed written informed consent of the patient.
•·Women of childbearing potential must use reliable contraception methods during the study period.
•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

•·Patients with life-threatening manifestation including glomerulonephritis, neuropsychiatric involvement, systemic vasculitis
•·Patients with M-components with and without rheumatoid factor activity
•·Known hypersensitivity to any of the drug components
•·Bleeding disorder requiring treatment
•·Antiphospholipid syndrome
•·Severe infections, malignancy, severe cardiovascular disorder
•·Females who are currently pregnant or breast feeding, or who plan to become pregnant during the course of the study.
•·Patients treated with hydroxychlorochin, azathioprine, mycofenolate-mofetil and methotrexate if not on stable treatment for > 3 months
•·Patients treated with immunomodulating and/or cytostatic drugs (cyclophosphamide, ciclosporin-A within 6 months and anti-B cell therapy (rituximab) within 1 year.
•·Patients treated with anticoagulant drugs e.g. warfarin or heparin. Treatment with low dose of acetylsalicylic acid (trombyl® is allowed
•·Patients treated with Subcuvia® / or other immunoglobulin within the previous 12 months.
•·Patients who are participating in any other clinical studies, or who have participated in such a study within the previous six months.

发起方

Department of Rheumatology,University hospital,Lund