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NCT Number: NCT07080125

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Interstitial Lung Diseases Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases Systemic Sclerosis Associated Interstitial Lung Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

EUSTAR Registry

Basel, 4051, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Ofev®

Drug

Ofev®

Other names: Nintedanib

Primary outcomes

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

Secondary outcomes

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

  6. Time to death

    Time frame: up to 10 years

  7. Change from baseline in FVC (% predicted)

    Time frame: at baseline, up to 10 years

  8. Change from baseline in FVC (ml)

    Time frame: 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

    Time frame: at baseline, up to 10 years

    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.

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

    Time frame: up to 10 years

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

    • time to all-cause death;
    • 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

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

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

    Time frame: up to 10 years

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Jul 23, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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