Rituximab in Interstitial Pneumonitis (RITUX-IP)

May 30, 2018 updated by: Human Adams

Rituximab in Life Threatening Therapy Resistant Progressive 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands
        • St. Antonius Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: rituximab
single arm study with Zr-89-rituximab immuno PET/CT
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
Other Names:
  • Immuno PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3, 6 days after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Human Adams

Collaborators

Amsterdam UMC, location VUmc

Investigators

  • Principal Investigator: J C Grutters, MD, PhD, St. Antonius Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

September 23, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 29, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49534.100.14
  • 2013-005269-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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