Dual immunosuppression alone versus dual immunosuppression plus antifibrotic for scleroderma-related interstitial lung disease
Official title: Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
Run by University of Patras · NCT07491523 · Data updated 2026-11-12
This project will test whether adding an antifibrotic drug to dual immunosuppression helps people with scleroderma-related interstitial lung disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | University of Patras Academic / other |
| Locations | 1 site (Pátrai) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | July 2026 |
| Study ends | March 2027 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07491523 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with systemic sclerosis and interstitial lung disease who are receiving dual immunosuppressive therapy and are followed at the University of Patras.
✕Probably not a fit
People with systemic sclerosis who do not have interstitial lung disease or who are not on dual immunosuppression would not be expected to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective cohort comparison of patients with diffuse systemic sclerosis-associated interstitial lung disease who receive dual immunosuppression alone or dual immunosuppression combined with an antifibrotic (nintedanib or pirfenidone). Investigators will review medical records at the Rheumatology Department of the University General Hospital of Patras to collect longitudinal lung function, imaging, treatment, and clinical outcome data. Because pulmonary fibrosis progresses slowly, the analysis will focus on measures such as FVC decline, radiographic progression, and clinical events over available follow-up. The study aims to describe real-world differences in disease progression and safety between the two treatment approaches.
Why it matters
Potential benefit: If successful, adding an antifibrotic could slow lung function decline and reduce progression of pulmonary fibrosis in people with scleroderma-ILD.
How similar studies have gone: Randomized trials such as SENSCIS have shown that nintedanib can slow FVC decline in scleroderma-ILD, but real-world comparisons of combined antifibrotic plus dual immunosuppression versus dual immunosuppression alone are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:ild-ssc with double immunosuppression \- Exclusion Criteria: * ssc without ild
Where it's running
-
University of patras
Pátrai, Greece Recruiting
Study contacts
- Study coordinator: Stamatis Nick Liossis C Professor, MD, PhD
- Email: snliossis@med.upatras.gr
- Phone: +306977066105
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.