SE OF ABATACEPT IN ANCA-ASSOCIATED VASCULITIS - ABAVAS

AZIENDA OSPEDALIERA DI PARMA0 个研究点目标入组 112 人开始时间: 2008年6月27日最近更新: 2014年1月27日

试验速览

暂无简介。

•Males and females (not nursing and not pregnant) at least 18 years of age. Women of child bearing potential are eligible if they are practicing effective contraceptive measures With Acute AAV, presenting at first diagnosis or relapse (not grumblers, to maximize effect seen), defined by clinical presentation with Wegener?s Granulomatosis (WG), microscopic polyangiitis (MPA) or Churg-Strauss syndrome (CSS)* and ANCA positivity (anti-MPO or anti-PR3 positive) or historical ANCA positivity, and a BVAS score of > 8. Written informed consent given
•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

•Those with severe life-threatening disease, i.e. lung haemorrhage at the time of presentation, renal impairment with SCr>150 mcmol/l, or severe CNS dysfunction thought to be due to vasculitis. Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease, or other medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. With any other non-vasculitic multisystem autoimmune disease. With any serious acute bacterial infection unless treated and completely resolved with antibiotics prior to enrollment With any severe chronic or recurrent bacterial infection, e g. bronchiectasis, osteomyelitis, chronic pyelonephritis With Hepatitis B or C or HIV. With Herpes zoster infection that resolved less than 2 months prior to enrollment. Subjects who have received any live vaccines* within 3 months of the first dose of study medication or who will have need of a live vaccine at any time in the year following enrollment.

发起方

AZIENDA OSPEDALIERA DI PARMA