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Rituximab in Interstitial Pneumonitis (RITUX-IP)

Primary Purpose

Lung Diseases, Interstitial, Pneumonitis, Interstitial

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Rituximab
Zr-89-rituximab immuno PET/CT
Sponsored by
Human Adams
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases, Interstitial focused on measuring IMID, Interstitial Pneumonitis, rituximab, Immuno PET, PET/CT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Antonius Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

rituximab

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
September 23, 2014
Last Updated
May 30, 2018
Sponsor
Human Adams
Collaborators
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT02251964
Brief Title
Rituximab in Interstitial Pneumonitis
Acronym
RITUX-IP
Official Title
Rituximab in Life Threatening Therapy Resistant Progressive Interstitial Pneumonitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Human Adams
Collaborators
Amsterdam UMC, location VUmc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial, Pneumonitis, Interstitial
Keywords
IMID, Interstitial Pneumonitis, rituximab, Immuno PET, PET/CT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rituximab
Arm Type
Other
Arm Description
single arm study with Zr-89-rituximab immuno PET/CT
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
2 times 1000mg dose at 14 days interval treatment
Intervention Type
Radiation
Intervention Name(s)
Zr-89-rituximab immuno PET/CT
Other Intervention Name(s)
Immuno PET
Intervention Description
Immuno labeled PET/CT of the lungs
Primary Outcome Measure Information:
Title
Pulmonary function (VC, DLCO)
Description
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 Outcome Measure Information:
Title
Zr-89 Immuno PET
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J C Grutters, MD, PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Rituximab in Interstitial Pneumonitis

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