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CompletedNCT02251964RITUX-IPUpdated May 31, 2018

Rituximab in Interstitial Pneumonitis

A Phase 2/3 interventional study of Rituximab and Zr-89-rituximab immuno PET/CT in Lung Diseases, Interstitial and Pneumonitis, Interstitial, sponsored by Human Adams. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Human Adams · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Diseases, Interstitial
  • Pneumonitis, Interstitial

Keywords

  • IMID
  • Interstitial Pneumonitis
  • rituximab
  • Immuno PET
  • PET/CT
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 20 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

This is the only study on the registry with Human Adams as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    rituximab

    single arm study with Zr-89-rituximab immuno PET/CT

    Drug: Rituximab · Radiation: Zr-89-rituximab immuno PET/CT

Interventions

  • DrugRituximab

    2 times 1000mg dose at 14 days interval treatment

  • RadiationZr-89-rituximab immuno PET/CT

    Immuno labeled PET/CT of the lungs

    Also known as: Immuno PET

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 - 12 months

Secondary outcomes

  1. 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.

    Time frame: 3, 6 days after injection

07

Study locations

1 site
  • St. Antonius Hospital
    Nieuwegein, Utrecht, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02251964
Lead sponsor
Human Adams
Collaborators
Amsterdam UMC, location VUmc
Responsible party
Human Adams (Prof. Dr. D.H. Biesma, St. Antonius Hospital) — Sponsor-investigator
First posted
Sep 29, 2014
Start date
Sep 2014
Primary completion
Oct 2017
Completion
Feb 2018
Last update
May 31, 2018

Study contacts

J C Grutters, MD, PhD
principal investigator · St. Antonius Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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