Rituximab in Interstitial Pneumonitis

Lung Diseases, Interstitial Clinical Trial

— RITUX-IP  

Official title:

Rituximab in Life Threatening Therapy Resistant Progressive Interstitial Pneumonitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251964
• Other study ID #: NL49534.100.14
• Secondary ID: 2013-005269-37
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2014
• Est. completion date: February 2018

Study information

• Verified date: May 2018
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project will address rare immune mediated inflammatory diseases (IMIDs) involving the lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary study parameter is pulmonary function.

The secondary objectives are to explore the application of imaging with radiolabeled RTX as early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

In order to be eligible to participate in the study, subjects must meet all of the following criteria:

• Age 18 to 70 years

• No previous therapy with rituximab

• At least 2 pulmonary function tests within past 6 months

• Diagnosis of co-existing IMID and a severe and / or progressive IP characterized by 3 out of the following items:

• Respiratory symptoms consistent with interstitial lung disease

• 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

• High Resolution Computer Tomography (HRCT) scan showing definite or probable UIP/NSIP/OP/mixed

• Forced Vital Capacity (FVC) < 50% predicted and/or diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted or worsening of lung function 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(cyclophosphamide or azathioprine)

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 + resting Oxygen Saturation (SAO2) without external oxygen <90%

• 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

• Hypersensitivity for murine proteins

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Pneumonia
• Pneumonitis, Interstitial

Intervention

Drug:
• Rituximab
2 times 1000mg dose at 14 days interval treatment

Radiation:
• Zr-89-rituximab immuno PET/CT
Immuno labeled PET/CT of the lungs

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Human Adams	VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function (VC, DLCO)	establish a change from the downward decline in pulmonary function (absolute values and values predicted of VC = Vital Capacity and DLCO = Diffusion capacity of Lung Carbon monoxide)	6 - 12 months
Secondary	Zr-89 Immuno PET	This is a scan with radiolabelled rituximab (visualizing rituximab activity in the lungs). Calculated activity (SUV) in the lungs vs. blood pool vs liver vs.control group (n=15) is measured with standard deviation. The amount of uptake in the lungs and the clinical response of patients will be correlated to determine a correlation.	3, 6 days after injection