RITUXIMAB IN PROGRESSIVE LUNG INFLAMMATIO

Conditions: Patients with rare Immune mediated inflammatory diseases (IMIDs) involving the lungs causing interstitial pneumonitis (IP).
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2013-005269-37-NL

Lead Sponsor: St. Antonius Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 <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)

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

• Residual volume >120% predicted at screening
• DLco <25% of predicted value at screening
• Evidence of active infection
• Pregnancy or lactation
• Hematology lower than specified limits
• Positive HIV, hepatitis B or C serology
• Fever (> 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