RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS - RITUX-IP TRIA

Sint Antonius Ziekenhuis0 个研究点目标入组 23 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Age: 18 - 70 years • No previous therapy with rituximab • Diagnosis of co-existing IMID and a severe and / or progressive IP by one of the following: - Clinical symptoms consistent with interstitial lung disease between 3 months and 3 years prior to screening - 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) • At least 2x PFT measurements in last 6 months

•A potential subject who meets any of the following criteria will be excluded from participation in this study: • Residual volume >120% predicted at screening • DLco <25% of predicted value at screening • History of unstable or deteriorating cardiac or neurological disease • Pregnancy or lactation • Hematology lower than specified limits (leucocytes) • Positive HIV, hepatitis B or C serology • Pre-existing conditions which lead to a life expectancy of less than 6 months. • Receipt of any vaccine, particularly live viral vaccines, within 4 weeks before first rituximab dose. NOTE: • Fever (> 37,9 °C) at presentation is reason to delay therapy by 1 week • Evidence of active infection is reason to postpone rituximab treatment until no further signs of active infection • Severe renal impairment is not a contraindication for rituximab therapy, however if patients (might) require dialysis frequently they will be excluded from the study group.

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