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Interstitial Lung DiseasesNCT07080125

A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis

An observational study of Interstitial Lung Diseases and Systemic Sclerosis Associated Interstitial Lung Disease, run by Boehringer Ingelheim at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This post-approval registry study is planned to generate data to address remaining questions on long-term effectiveness and to better characterize longer term beneficial effects of Nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) in terms of survival, quality of life… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ofev®
How many people
2,000 participants
Where
1 siteSwitzerland
Study dates
17 Jun 2025to 31 Dec 2033
Phase
Observational
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

Study population: The study cohort will constitute patients with Systemic Sclerosis (SSc) and Interstitial Lung Disease (ILD) (based on radiological evidence) enrolled in the European Scleroderma Trials and Research (EUSTAR) registry.

Who may be able to join

  • Enrolled in the EUSTAR registry
  • Provided consent at their site to have their data included in the EUSTAR registry for a broad range of research studies, and agree to visit the site every 12 months
  • Have a diagnosis of ILD defined by radiological findings on High Resolution Computed Tomography (HRCT) and/or X-ray that is documented in the electronic Case Report Form (eCRF) by the treating physician

Who cannot join

  • Women with Systemic Sclerosis Interstitial Lung Disease (SSc-ILD) who are pregnant, or breastfeeding will be excluded since Ofev® is contraindicated for women who are pregnant due to safety concerns
  • SSc-ILD patients aged <18 years: only adults will be included in the study since Ofev® is approved for treatment of SSc-ILD in adults
  • Patients with a previous Hematopoietic Stem Cell Transplantation (HSCT)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • EUSTAR Registry

    Basel, 4051

Other trials in Switzerland

About this study

Official title: Non-interventional Post-authorization Effectiveness Study to Assess Long-term Outcomes of Nintedanib Treatment in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

This post-approval registry study is planned to generate data to address remaining questions on long-term effectiveness and to better characterize longer term beneficial effects of Nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) in terms of survival, quality of life, pattern of disease progression as well as effectiveness and safety in the subgroup of patients with pulmonary hypertension.

Being tested
Ofev®
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.

  • Ofev®Drug

    Also called Nintedanib

    Ofev®

Study groups in NCT07080125
Study groupRoleWhat they receive
Exposed groupIndividuals that initiate Ofev® including either: 1. with an ongoing or new immunosuppressive therapy (IST) regimen (i.e., Ofev® combination therapy) or 2. after discontinuing an IST regimen or individuals that have never been on IST (i.e. Ofev® monotherapy)
Receives: Drug: Ofev®
Unexposed groupIndividuals that do not initiate Ofev® during the study period and can include the following: 1. Individuals on an IST regimen, described as 1a) those without an IST treatment escalation and 1b) those with an IST treatment escalation (i.e., increased dose, additional IST, switch in IST) to treat ILD- or non-ILD related SSc organ manifestations (e.g., mycophenolate, cyclophosphamide, methotrexate, tocilizumab, rituximab, etc.) 2. Individuals who receive no IST

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to absolute Forced Vital Capacity (FVC) decline (% predicted) ≥5%, lung transplantation (indicating end stage ILD), or death

    Measured: up to 10 years

  2. Time to absolute FVC decline (% predicted) ≥10%, lung transplantation (indicating end-stage ILD), or deat

    Measured: up to 10 years

Secondary outcomes (19)

  1. Time to absolute (% predicted) FVC decline ≥5%

    Measured: up to 10 years

  2. Time to absolute (% predicted) FVC decline ≥10%

    Measured: up to 10 years

  3. Time to relative (ml) FVC decline ≥5%

    Measured: up to 10 years

  4. Time to relative (ml) FVC decline ≥10%

    Measured: up to 10 years

  5. Time to lung transplantation (indicating end-stage ILD)

    Measured: up to 10 years

  6. Time to death

    Measured: up to 10 years

  7. Change from baseline in FVC (% predicted)

    Measured: at baseline, up to 10 years

  8. Change from baseline in FVC (ml)

    Measured: at baseline, up to 10 years

  9. Lung specific Quality of Life (QoL) measured as change from baseline of total, impact, and symptom scores using the Living with Pulmonary Fibrosis (L-PF) questionnaire, measured as change of baseline at years 1, 2, 3,….10

    The L-PF patient reported outcome measure (PROM) is a questionnaire designed for patients with fibrosing ILDs and developed with those patients to investigate their level of symptoms and QoL.

    The L-PF consists of two modules, symptoms and impacts, and five scales: symptoms total, dyspnea, cough, fatigue, impacts total, and Total L-PF score.

    Items in both modules have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely". Overall scores range from 0 to 100, with higher numbers indicating a greater impairment.

    Measured: at baseline, up to 10 years

  10. Time to worsening of Pulmonary Hypertension (PH) in the sub-population of patients with PH at baseline

    Worsening of PH is defined as a composite outcome of the following:

    1. time to all-cause death;
    2. time to non-planned PH-related hospitalization; or 3) time to PH-related deterioration identified by at least one of the following parameters: i. increase in World Health organization functional class, ii. deterioration in exercise testing; or iii. Signs or symptoms of right-sided heart failure

    Measured: up to 10 years

  11. Incidence rate of major bleeding (defined as those requiring intervention or hospitalization) in exposed vs unexposed treatment groups

    Measured: up to 10 years

  12. Final outcome for the major bleeding events (i.e., recovered or fatal) overall

    Measured: up to 10 years

  13. Proportion of patients with major bleeding that had a pre-existing risk for bleeding

    Measured: up to 10 years

  14. Incidence rate of gastrointestinal perforations in exposed vs unexposed treatment groups

    Measured: up to 10 years

  15. Final outcome (i.e., recovered or fatal) for gastrointestinal perforation events overall

    Measured: up to 10 years

  16. Proportion of patients with gastrointestinal perforations that had a pre-existing risk for gastrointestinal perforations

    Measured: up to 10 years

  17. Incidence rate of thromboembolism (arterial or venous) in exposed vs unexposed treatment groups

    Measured: up to 10 years

  18. Final outcome (i.e., recovered or fatal) for thromboembolic events overall

    Measured: up to 10 years

  19. Proportion of patients with thromboembolism that had a pre-existing risk for thromboembolism

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start17 Jun 2025
  3. Primary completion31 Dec 2033 (estimated)
  4. Study completion31 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07080125
Sponsor's protocol ID
1199-0421
Other IDs
EUPAS106792
Status last verified
Dec 2025
First submitted
15 Jul 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Questions about this trial

What is this clinical trial studying?

An observational study of Interstitial Lung Diseases and Systemic Sclerosis Associated Interstitial Lung Disease, run by Boehringer Ingelheim at 1 site in Switzerland.

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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. 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 Switzerland. 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?

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?

Time to absolute Forced Vital Capacity (FVC) decline (% predicted) ≥5%, lung transplantation (indicating end stage ILD), or death (time frame: up to 10 years). The study lists 2 primary outcomes in all. 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 NCT07080125.

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 8 Dec 2025.

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