Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD

Patients with ssc-ild receiving double immunosuppression with or without anti fibrotic tratment

Study Overview

• Status: Recruiting
• Conditions: SSc-Systemic Sclerosis
• Intervention / Treatment: Drug: Antifibrotic drugs (nidanib or pirfenidone); Drug: MMF Immunosuppression

Detailed Description

Systemic sclerosis (scleroderma) is a rare systemic autoimmune disease. It primarily affects the skin, but it can also involve other vital organs and systems, and is characterized by fibrosis, vascular abnormalities, and the production of autoantibodies. Its main pathological feature is the excessive production and deposition of collagen in the skin and other organs.

Mortality in scleroderma varies depending on the type and severity of the disease, particularly on whether vital organs are involved. Patients with limited cutaneous scleroderma generally have a better prognosis and life expectancy, whereas those with diffuse scleroderma face a higher risk of death from disease-related complications, mainly due to lung involvement.

Pulmonary involvement in scleroderma is common, either affecting the pulmonary blood vessels (pulmonary hypertension) or the supporting structure (interstitium) of the lungs, leading to interstitial fibrosis.

Objective:

The aim of the study is to compare patients receiving only dual immunosuppressive therapy (control group) with patients receiving dual immunosuppressive therapy combined with antifibrotic treatment (e.g., nintedanib).

Methods:

This will be a retrospective study including patients with scleroderma and diffuse pulmonary fibrosis who are followed at the Rheumatology Department of the University General Hospital of Patras and are receiving the two proposed treatment regimens. Because fibrosis and its progression are slow processes, we propose a comparative analysis of outcomes in both groups at 2 years from treatment initiation.

Inclusion criteria:

Presence of pulmonary fibrosis (documented by chest HRCT), regardless of whether pulmonary function tests show a restrictive pattern or not.

Availability of pulmonary function tests for each patient at the following time points:

0 months (baseline) 6 months 12 months Patients (controls) should be receiving either dual therapy (MMF + RTX) or triple therapy (MMF + RTX + nintedanib).

Analysis:

Statistical analysis will be performed using the unpaired two-tailed Student's t-test.

Expected results / originality / contribution to science:

To date, no similar study exists in the international literature. Since interstitial lung disease is the leading cause of death in patients with scleroderma, the results of this study may contribute to improved management. We hypothesize that the combination of dual immunosuppressive therapy and antifibrotic treatment will be superior to dual immunosuppressive therapy alone.

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Stamatis Nick Liossis C Professor, MD, PhD; Phone Number: +306977066105; Email: snliossis@med.upatras.gr

Study Locations

• Greece
  • Pátrai, Greece
    • Recruiting
    • University of Patras
    • Contact: University of patraS SNL, PROF; Phone Number: +30 697 7066105; Email: snliossis@med.upatras.gr
    • Sub-Investigator: stephanie erotokritou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ssc-ild

Description

Inclusion Criteria:ild-ssc with double immunosuppression

-

Exclusion Criteria:

• ssc without ild

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic; Comparison of the two groups	Drug: Antifibrotic drugs (nidanib or pirfenidone); Ssc - ild; Drug: MMF Immunosuppression; we will compare patients with SSc-ILD taking RTX and mmf and patients that are taking RTX,mmf and nintedanib; Other Names: RITUXIMAB
Patient with ssc-ild with a double immunosuppression treatment only; Patients with rituximab and mmf	Drug: MMF Immunosuppression; we will compare patients with SSc-ILD taking RTX and mmf and patients that are taking RTX,mmf and nintedanib; Other Names: RITUXIMAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulmonary function test	For outcome number 1: FVC as a percentage compared to normal values (for age, sex, weight) at: Baseline and at 3, 6 and 12 months of treatment. Comparisons will be performed between baseline and each subsequent value at each prespecified time point. For outcome number 2: FEV1 as a percentage compared to normal values (for age, sex, weight) at: Baseline and at 3, 6 and 12 months of treatment. Comparisons will be performed between baseline and each subsequent value obtained at each prespecified time point. For outcome number 3: FEV1/FVC (ratio) compared to normal values (for age, sex, weight) at: Baseline and at 3, 6 and 12 months of treatment. Comparisons will be performed between baseline and each subsequent value obtained at each prespecified time point. For outcome number 4: TLCO (corrected for Ht) as a percentage compared to normal values (for age, sex, weight) at: Baseline and at 3, 6 and 12 months of treatment. Comparisons will be performed as described above.	From enrollment till the end of study -1 years later

Collaborators and Investigators

• Sponsor: University of Patras

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Rituximab; pirfenidone
• Other Study ID Numbers: University of Patra

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes