Lung Diseases, InterstitialPhase 2/3RITUX-IPNCT02251964
Rituximab in Interstitial Pneumonitis
A Phase 2/3 study testing Rituximab and Zr-89-rituximab immuno PET/CT in people with Lung Diseases, Interstitial and Pneumonitis, Interstitial, run by Human Adams at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Diseases, Interstitial, Pneumonitis, Interstitial
- What is being tested?
- Rituximab and Zr-89-rituximab immuno PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Feb 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Rituximab, Zr-89-rituximab immuno PET/CT
- Keywords
- IMID, Interstitial Pneumonitis, rituximab, Immuno PET, PET/CT
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
2 times 1000mg dose at 14 days interval treatment
Zr-89-rituximab immuno PET/CTRadiation
Also called Immuno PET
Immuno labeled PET/CT of the lungs
| Study group | Role | What they receive |
|---|---|---|
| rituximab | Other | single arm study with Zr-89-rituximab immuno PET/CT Receives: Drug: Rituximab; Radiation: Zr-89-rituximab immuno PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 3, 6 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Human Adams
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Responsible party
- Sponsor-investigator, Human Adams, St. Antonius Hospital
- Investigators
- J C Grutters, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251964
- Sponsor's protocol ID
- NL49534.100.14
- Other IDs
- 2013-005269-37
- Acronym
- RITUX-IP
- Status last verified
- May 2018
- First submitted
- 23 Sep 2014
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Adams H, van de Garde EMW, Vugts DJ, Grutters JC, Oyen WJG, Keijsers RG. [89Zr]-immuno-PET prediction of response to rituximab treatment in patients with therapy refractory interstitial pneumonitis: a phase 2 trial. Eur J Nucl Med Mol Imaging. 2023 Jun;50(7):1929-1939. doi: 10.1007/s00259-023-06143-1. Epub 2023 Feb 24.
PubMed 36826476
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab in Life Threatening Therapy Resistant Progressive Interstitial Pneumonitis
- ClinicalTrials.gov ID
- NCT02251964
- Acronym / sponsor ID
- RITUX-IP / NL49534.100.14
- Keywords
- IMID, Interstitial Pneumonitis, rituximab, Immuno PET, PET/CT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Human AdamsUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc
- Study start
- Sep 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rituximab | Other | Drug: Rituximab, Radiation: Zr-89-rituximab immuno PET/CTsingle arm study with Zr-89-rituximab immuno PET/CT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab2 times 1000mg dose at 14 days interval treatment | Drug | rituximab |
| Zr-89-rituximab immuno PET/CTAlso: Immuno PETImmuno labeled PET/CT of the lungs | Radiation | rituximab |
Primary outcome
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)
1 secondary outcome
Zr-89 Immuno PET
Time frame: 3, 6 days after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Derived from this study: PubMed 36826476Adams H, van de Garde EMW, Vugts DJ, Grutters JC, Oyen WJG, Keijsers RG. [89Zr]-immuno-PET prediction of response to rituximab treatment in patients with therapy refractory interstitial pneumonitis: a phase 2 trial. Eur J Nucl Med Mol Imaging. 2023 Jun;50(7):1929-1939. doi: 10.1007/s00259-023-06143-1. Epub 2023 Feb 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J C Grutters, MD, PhD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Rituximab and Zr-89-rituximab immuno PET/CT in people with Lung Diseases, Interstitial and Pneumonitis, Interstitial, run by Human Adams at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (VC, DLCO) (time frame: 6 - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02251964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.