RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS

St. Antonius Hospital0 个研究点开始时间: 2014年7月24日最近更新: 2014年10月27日

适应症

试验速览

暂无简介。

•Age 18 - 70 years
•No previous therapy with rituximab
•Diagnosis of severe and / or progressive IMID-IP by one of the following
•-Clinical symptoms consistent with interstitial lung disease between 3 months and 3 years prior to screening and co-existing IMID
•-FVC <50% pred. and/or DLCO <40% pred.
•-Diagnosis of usual interstitial pneumonia (UIP), non-specific interstitial pneumonia (NSIP), Organizing pneumonia (OP) or a mixed form of UIP / NSIP / OP by either of the following:
•?Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP / NSIP / OP
•-HRCT scan showing definite or probable UIP / NSIP / OP / mixed
•-Worsening as demonstrated by any one of the following within the past year:
•?> 10% decrease in FVC
•?> 15% decrease in DLCO
•Therapy resistance to 1st (corticosteroids) and 2nd line therapy (cyclophosamide, AZT)
•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 19
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•Residual volume >120% predicted at screening
•DLco <25% of predicted value at screening
•Evidence of active infection
•Pregnancy or lactation
•Hematology lower than specified limits
•Positive HIV, hepatitis B or C serology
•Fever (> 37,9 °C)
•Previous allergic reaction to monoclonal antibodies (e.g. infliximab)
•Receipt of any vaccine, particularly live viral vaccines, within 4 weeks before first rituximab dose.
•NYHA IV heart failure
•Renal failure requiring dialysis
•History of unstable or deteriorating neurological disease
•Any medical condition, which in the opinion of the principal investigator and/or clinician, may be adversely affected by the participation of the study

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