RITUXIMAB IN LIFE THREATENING THERAPY RESISTANT PROGRESSIVE INTERSTITIAL PNEUMONITIS

Phase 2

Withdrawn

Conditions: IMID
insterstitial pneumonitis
10003816
10024967

Registration Number: NL-OMON40302

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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)

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.<br /><br><br /><br>a) Our primary goals can be measured by improvement of lung function in and<br /><br>improvement in the quality of life (QoL). Note: Mortality will not be a primary<br /><br>outcome measure since patients are at least expected to survive the follow-up<br /><br>period of 6months to 1 year.</p><br>

Secondary Outcome Measures

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