RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS

Completed

Conditions: auto-immune mediated insterstitial pneumonitis
10003816
10024967

Registration Number: NL-OMON41026

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 23

Inclusion Criteria

• 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

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 • 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective of this study is to assess the effects of rituximab as a<br /><br>rescue therapy for rare therapy resistant progressive IMID- IP patients. a) Our<br /><br>primary goals can be measured by improvement of lung function in and<br /><br>improvement in the quality of life (QoL).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Our secondary objectives are to assess potential predictors b) Parallel to the<br /><br>treatment effect we will study additional parameters to potentially predict<br /><br>treatment effect. The first consists of a unique rituximab scan to visualize<br /><br>the potential binding sites for CD20 cells (and thus rituximab treatment<br /><br>efficacy) and second, there are specific molecular markers assessed by blood<br /><br>analysis which may give additional insight in the disease. Additional<br /><br>objectives are to assess the cost burden of the disease: c) Cost effectiveness:<br /><br>these consist of the cost savings when preventing or delaying lung transplants<br /><br>vs. the cost of rituximab, improvement in lung function and quality of life. </p><br>