Dual immunosuppression alone versus dual immunosuppression plus antifibrotic for scleroderma-related interstitial lung disease
Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
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 |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Patras Academic / other |
| Locations | 1 site (Pátrai) |
| Trial ID | NCT07491523 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:ild-ssc with double immunosuppression \- Exclusion Criteria: * ssc without ild
Where this trial is running
Pátrai
- University of patras — Pátrai, Greece (Recruiting)
Study contacts
- Study coordinator: Stamatis Nick Liossis C Professor, MD, PhD
- Email: snliossis@med.upatras.gr
- Phone: +306977066105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.