RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS - Rituximab in Interstitial Pneumonitis: RITUX-IP TRIA

Sint Antonius Ziekenhuis0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月29日

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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)

•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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