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Completed

NCT Number: NCT02251964

Rituximab in Interstitial Pneumonitis

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.

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Key information

Conditions

Lung Diseases, Interstitial Lung Diseases Pneumonitis, Interstitial Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

2 times 1000mg dose at 14 days interval treatment

Zr-89-rituximab immuno PET/CT

Radiation

Immuno labeled PET/CT of the lungs

Other names: Immuno PET

Primary outcomes

  1. Pulmonary function (VC, DLCO)

    Time frame: 6 - 12 months

    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)

Secondary outcomes

  1. Zr-89 Immuno PET

    Time frame: 3, 6 days after injection

    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.

Sponsors and collaborators

Lead sponsor

Human Adams

Other

Collaborators

  • Amsterdam UMC, location VUmc

Registry information

Official study title

Rituximab in Life Threatening Therapy Resistant Progressive Interstitial Pneumonitis

Acronym: RITUX-IP

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Sep 29, 2014
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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