Patients with rare Immune mediated inflammatory diseases (IMIDs) involving the lungs causing interstitial pneumonitis (IP).
Conditions
Interventions
Product Name: Zirconium-89 Rituximab
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
St. Antonius Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 - 70 years • No previous therapy with rituximab • Diagnosis of severe and / or progressive IMID-IP by one of the following - Clinical symptoms consistent with interstitial lung disease between 3 months and 3 years prior to screening and co-existing IMID - FVC 10% decrease in FVC ? > 15% decrease in DLCO • Therapy resistance to 1st (corticosteroids) and 2nd line therapy (cyclophosamide, AZT) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 19 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: • Residual volume >120% predicted at screening • DLco 37,9 °C) • Previous allergic reaction to monoclonal antibodies (e.g. infliximab) • Receipt of any vaccine, particularly live viral vaccines, within 4 weeks before first rituximab dose. • NYHA IV heart failure • Renal failure requiring dialysis • History of unstable or deteriorating neurological disease • Any medical condition, which in the opinion of the principal investigator and/or clinician, may be adversely affected by the participation of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are to assess the value of (1) various prognostic markers biomarkers (2) an innovative rituximab scan to visualize RTX target sites (3) cost effectiveness of the RTX treatment;Primary end point(s): • Lung function test parameters - Diffusion Capacity for Carbon Monoxide (DLco) - Forced Vital Capacity (FVC) • Quality of life assessment over time - SF-36 - EQ-5D ;Timepoint(s) of evaluation of this end point: follow up 3, 6, 9 and 12 months after first dose treatment with rituximab;Main Objective: This project will address rare Immune mediated inflammatory diseases (IMIDs) involving the lungs. When left untreated, interstitial pneumonitis (IP) can lead to poor quality of life and increased mortality. The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for therapy resistant progressive IMID- IP patients. Specifically there is an assessment of (1) pulmonary function tests (PFTs) and (2) Quality of Life measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary (prediction) • Imaging parameters: - Immuno PET/CT: by Zr-89-rituximab - HRCT: changes - FDG PET-CT: SUV mean • Specific molecular markers: (ACE, sIL2R, CA 15.3, LDH, CRP, TH17/IL-17, CD27, IgD, IgG, IgM, specific chemokines and cytokines after multiplex analyses) • Cost assessment of rituximab vs prevention or delay of lung lungtransplants ;Timepoint(s) of evaluation of this end point: after inclusion of patients, rituximab treatment patients will be monitored. If the first 10 immuno-PET scans are positive, then the other 10 scans will be continued. Analysis of first 10 scans will be within 6 months, the biomarkers results and cost assessments follow at the end of the study. | — |
Countries
Netherlands
Contacts
Public ContactProf.dr.D.H. Biesma
St. Antonius Hospital
Outcome results
None listed