Rituximab in Interstitial Pneumonitis

Launched by HUMAN ADAMS · Sep 25, 2014

Keywords

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Eligibility criteria

• Inclusion Criteria:
• In order to be eligible to participate in the study, subjects must meet all of the following criteria:
• • Age 18 to 70 years
• • No previous therapy with rituximab
• • At least 2 pulmonary function tests within past 6 months
• * Diagnosis of co-existing IMID and a severe and / or progressive IP characterized by 3 out of the following items:
• • Respiratory symptoms consistent with interstitial lung disease
• * 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
• • High Resolution Computer Tomography (HRCT) scan showing definite or probable UIP/NSIP/OP/mixed
• * Forced Vital Capacity (FVC) \< 50% predicted and/or diffusing capacity of the lung for carbon monoxide (DLCO) \< 40% predicted or worsening of lung function 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(cyclophosphamide or azathioprine)
• Exclusion Criteria:
• 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 + resting Oxygen Saturation (SAO2) without external oxygen \<90%
• • 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
• • Hypersensitivity for murine proteins
• 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