Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified ElsewhereRMD-mILDerNCT06732674
Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
A study testing A home monitoring strategy with event driven management in people with Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere and Systemic Sclerosis Pulmonary, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The RMD-mILDer trial is a home monitoring strategy trial aiming to improve management of interstitial lung disease related to rheumatic diseases applying eHealth technology. It is planned as a 2 arm 54 week multi-centre randomised controlled trial to assess outcome of home monitoring with bi-weekly serial forced vital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere, Systemic Sclerosis Pulmonary, Dermatomyositis
- What is being tested?
- A home monitoring strategy with event driven management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteNorway
- Study dates
- 16 Dec 2024to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemic rheumatic disease (Systemic sclerosis (SSc), rheumatoid arthritis (RA), idiopathic inflammatory myopathies including antisynthetasis syndromes (IIM), mixed connective tissue disease (MCTD) or Sjøgrens disease (SjD)) classifiable by disease-specific classification criteria
- Diagnosed interstitial lung disease (ILD) on high resolution computed tomography (HRCT) ≥ 1 year prior to randomization, not explained by other diseases or exposures
- On stable standard of care treatment 6 months prior to randomization
- Participants must be able to understand and follow trial procedures including completion of questionnaires regarding Patient Reported Outcome measures
- Participants must have access to the internet, and experience in using smartphones or other electronic devices with internet access
- Signed informed consent form
Who cannot join
- Severe heart failure with ejection fraction (EF) < 30%
- Chronic renal failure G4 or more (defined by KDIGO) with glomerular filtration rate (eGFR) < 30 mL/min using Cockroft-Gault formula.
- End stage lung disease with forced vital capacity (FVC) < 50% and/or diffusion capacity for carbon monoxide (DLCO) < 40% or coexisting severe other lung diseases (e.g. chronic obstructive pulmonary disease, emphysema)
- Airway obstruction (pre-bronchodilator FEV1/FVC < 0.7) (FEV1 is defined as forced expiratory volume in 1 sec)
- In the opinion of the investigator, other clinically significant pulmonary abnormalities
- Significant pulmonary hypertension defined by the following: Previous clinical or echocardiographic evidence of significant right heart failure OR history of right heart catheterization showing a cardiac index </= 2 L/min/m2 OR pulmonary hypertension requiring therapy with epoprostenol/treprostinil
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- Active treatment for cancer or non-curable cancer
- Relative contraindications to performing spirometry, as specified in ATS/ERS guidelines.
- Ongoing Prednisolone ≥ 20 mg/day at inclusion
- Unable to speak, write and read Norwegian, German or Romanian in the respective country of inclusion.
- Unable to perform good quality measurements of FVC on the home-device comparable to results on an in-hospital device, after training.
- Pregnancy or planned pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0873
Anna-Maria Hoffmann-Vold, Prof Dr, +4745224605, anna.hoffmannvold@gmail.com
Emily Langballe
About this study
Official title: A 54-week, Multi-centre, 2-arm, Randomised Controlled Trial to Assess Home Monitoring for Lung Function and Patient Reported Outcome Measurements Vs. Usual Care in RheuMatic Disease-associated Interstitial Lung Disease: the RMD-mILDer Trial
The RMD-mILDer trial is a home monitoring strategy trial aiming to improve management of interstitial lung disease related to rheumatic diseases applying eHealth technology.
It is planned as a 2 arm 54 week multi-centre randomised controlled trial to assess outcome of home monitoring with bi-weekly serial forced vital capacity- and patient reported outcome-measurements compared to standard of care with fixed-interval hospital visits in adult patients with rheumatic disease associated interstitial lung diseases.
- Conditions
- Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere, Systemic Sclerosis Pulmonary, Dermatomyositis, Rheumatoid Arthritis, Sjogren Syndrome with Lung Involvement, Connective Tissue Diseases
- Being tested
- A home monitoring strategy with event driven management
- Keywords
- home monitoring, remote monitoring, interstitial lung disease, rheumatic disease, lung fibrosis, Systemic sclerosis, Dermatomyositis, Sjøgren
- Medical subject headings
- Dermatomyositis, Arthritis, Rheumatoid, Connective Tissue Diseases, Lung Diseases, Interstitial, Rheumatic Diseases, Pulmonary Fibrosis, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A home monitoring strategy with event driven managementDiagnostic test
Bi-weekly home monitoring with forced vital capacity (FVC), patient reported outcome measures (PROMs), at-home measures of blood oxygen levels (SpO2) during 1-minute-sit-to-stand test (1MSTS) and temperature with algorithm based risk evaluation of deterioration and infection and consecutive event driven management
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Scheduled hospital visits every 6 months |
| Home monitoring | Experimental | Home monitoring strategy with remote patient data observation twice a week Receives: Diagnostic Test: A home monitoring strategy with event driven management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits.
Time from baseline to disease progression assessed as first forced vital capacity (FVC) ≥5% decline (assessed by hospital FVC measurements) or non-elective hospitalization due to respiratory cause.
Measured: 54 weeks
Secondary outcomes (4)
Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC
Absolute change from baseline in FVC (mL) and absolute change from baseline in FVC (% predicted).
Measured: after 54 weeks
Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events.
Proportion of patients who experience at least one FVC decline >= 10% event from baseline
Measured: baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms
Change in "Living with pulmonary fibrosis score" (LPF) total score, as well as the subdomains physical health, emotional well-being, social impact, functionality and daily activities as well as cognitive function where lower values indicate quality of life
Measured: baseline to week 54
Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events.
Proportion of patients who experience a progressive pulmonary fibrosis event defined as fibrosing ILD fulfilling ≥2 (out of 3) criteria (worsening respiratory symptoms, radiological progression, and physiological progression (absolute decline in FVC ≥ 5% predicted within 1 year follow up OR absolute decline in diffusion capacity for carbon monoxide (DLCO) ≥10% predicted within 1 year of follow up) occurring within the past year with no alternative explanation in a patient with ILD.
Measured: baseline to week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified ElsewhereStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- international, multi-center, 2-arm, 54-week, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, University of Zurich
- Responsible party
- Principal investigator, Anna-Maria Hoffmann-Vold, Oslo University Hospital
- Investigators
- Anna-Maria Hoffmann-Vold, MD, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732674
- Sponsor's protocol ID
- 535561
- Acronym
- RMD-mILDer
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual patient data of this study will not be publicly available as they contain information that could compromise the privacy of research participants and may be subject to ongoing research as long as the research project is ongoing. The original data will be available from the corresponding authors of subsequent publications upon reasonable request, except where restricted by GDPR liabilities.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 54-week, Multi-centre, 2-arm, Randomised Controlled Trial to Assess Home Monitoring for Lung Function and Patient Reported Outcome Measurements Vs. Usual Care in RheuMatic Disease-associated Interstitial Lung Disease: the RMD-mILDer Trial
- ClinicalTrials.gov ID
- NCT06732674
- Acronym / sponsor ID
- RMD-mILDer / 535561
- Conditions
- Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere, Systemic Sclerosis Pulmonary, Dermatomyositis, Rheumatoid Arthritis, Sjogren Syndrome with Lung Involvement, Connective Tissue Diseases
- Keywords
- home monitoring, remote monitoring, interstitial lung disease, rheumatic disease, lung fibrosis, Systemic sclerosis, Dermatomyositis, Sjøgren
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Carol Davila University of Medicine and Pharmacy, University of Zurich
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 13 Dec 2024 (actual)
- 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.
The RMD-mILDer trial is a home monitoring strategy trial aiming to improve management of interstitial lung disease related to rheumatic diseases applying eHealth technology.
It is planned as a 2 arm 54 week multi-centre randomised controlled trial to assess outcome of home monitoring with bi-weekly serial forced vital capacity- and patient reported outcome-measurements compared to standard of care with fixed-interval hospital visits in adult patients with rheumatic disease associated interstitial lung diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- international, multi-center, 2-arm, 54-week, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Scheduled hospital visits every 6 months |
| Home monitoring | Experimental | Diagnostic Test: A home monitoring strategy with event driven managementHome monitoring strategy with remote patient data observation twice a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Systemic rheumatic disease (Systemic sclerosis (SSc), rheumatoid arthritis (RA), idiopathic inflammatory myopathies including antisynthetasis syndromes (IIM), mixed connective tissue disease (MCTD) or Sjøgrens disease (SjD)) classifiable by disease-specific classification criteria
- Diagnosed interstitial lung disease (ILD) on high resolution computed tomography (HRCT) ≥ 1 year prior to randomization, not explained by other diseases or exposures
- On stable standard of care treatment 6 months prior to randomization
- Participants must be able to understand and follow trial procedures including completion of questionnaires regarding Patient Reported Outcome measures
- Participants must have access to the internet, and experience in using smartphones or other electronic devices with internet access
Key exclusion criteria (12 listed)
- Severe heart failure with ejection fraction (EF) < 30%
- Chronic renal failure G4 or more (defined by KDIGO) with glomerular filtration rate (eGFR) < 30 mL/min using Cockroft-Gault formula.
- End stage lung disease with forced vital capacity (FVC) < 50% and/or diffusion capacity for carbon monoxide (DLCO) < 40% or coexisting severe other lung diseases (e.g. chronic obstructive pulmonary disease, emphysema)
- Airway obstruction (pre-bronchodilator FEV1/FVC < 0.7) (FEV1 is defined as forced expiratory volume in 1 sec)
- In the opinion of the investigator, other clinically significant pulmonary abnormalities
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 |
|---|---|---|
| A home monitoring strategy with event driven managementBi-weekly home monitoring with forced vital capacity (FVC), patient reported outcome measures (PROMs), at-home measures of blood oxygen levels (SpO2) during 1-minute-sit-to-stand test (1MSTS) and temperature with algorithm based risk evaluation of deterioration and infection and consecutive event driven management | Diagnostic test | Home monitoring |
Primary outcome
Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits.
Time frame: 54 weeks
Time from baseline to disease progression assessed as first forced vital capacity (FVC) ≥5% decline (assessed by hospital FVC measurements) or non-elective hospitalization due to respiratory cause.
4 secondary outcomes
Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC
Time frame: after 54 weeks
Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events.
Time frame: baseline to week 54
Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms
Time frame: baseline to week 54
Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events.
Time frame: baseline to week 54
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- University homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No. The individual patient data of this study will not be publicly available as they contain information that could compromise the privacy of research participants and may be subject to ongoing research as long as the research project is ongoing. The original data will be available from the corresponding authors of subsequent publications upon reasonable request, except where restricted by GDPR liabilities.
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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.
Anna-Maria Hoffmann-Vold, MD, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A home monitoring strategy with event driven management in people with Interstitial Lung Disease with Progressive Fibrotic Phenotype in Diseases Classified Elsewhere and Systemic Sclerosis Pulmonary, run by Oslo University Hospital at 1 site in Norway.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 Dec 2024. 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 Norway. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily V Langballe, MD (0047 2307 0000, emilylangballe@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits. (time frame: 54 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2024.