Ilaris (Canakinumab) in the Schnitzler syndrome - canakinumab in Schnitzler

Z Leuven0 个研究点目标入组 3 人开始时间: 2010年12月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•oPatients with active Schnitzler syndrome after withdrawal of anakinra or tapering of corticosteroids.
•oMale and female patients at least 18 years of age at the time of screening visit.
•oSigned patient informed consent
•oNegative QuantiFERON test or negative Purified Protein Derivative (PPD) test (<5 mm induration) at screening or within 1 month prior to the screening visit, according to Belgium guidelines. Patients with a positive PPD test (=5 mm induration) at screeninig may be enrolled only if they have a negative chest x-ray or negative QuantiFERON test (QFT-TB G In-Tube).
•oAdequate contraception in females of childbearing potential.
•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

•oPregnant or nursing (lactating) women
•oHistory of being immunocompromised, including a positive HIV at screening (ELISA and Western blot)
•oSerologic evidence of active hepatitis B or C infection
•oLive vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
•oHistory of significant medical conditions, which in the investigator’s opinion would exclude the patient from participating in this trial.
•oHistory of recurrent and/or evidence of active bacterial, fungal or viral infection(s).

发起方

Z Leuven