auto-immune mediated insterstitial pneumonitis
Conditions
Interventions
None listed
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this study is to assess the effects of rituximab as a rescue therapy for rare therapy resistant progressive IMID- IP patients. a) Our primary goals can be measured by improvement of lung function in and improvement in the quality of life (QoL). | — |
Secondary
| Measure | Time frame |
|---|---|
| Our secondary objectives are to assess potential predictors b) Parallel to the treatment effect we will study additional parameters to potentially predict treatment effect. The first consists of a unique rituximab scan to visualize the potential binding sites for CD20 cells (and thus rituximab treatment efficacy) and second, there are specific molecular markers assessed by blood analysis which may give additional insight in the disease. Additional objectives are to assess the cost burden of the disease: c) Cost effectiveness: these consist of the cost savings when preventing or delaying lung transplants vs. the cost of rituximab, improvement in lung function and quality of life. | — |
Countries
Netherlands
Outcome results
None listed