SSc-Systemic SclerosisNCT07491523
Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
An observational study of SSc-Systemic Sclerosis, run by University of Patras at 1 site in Greece.
Trial summary
Patients with ssc-ild receiving double immunosuppression with or without anti fibrotic tratment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SSc-Systemic Sclerosis
- What is being tested?
- Antifibrotic drugs (nidanib or pirfenidone) and MMF Immunosuppression
- How many people
- 35 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2025to Mar 2027
- 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: Patients with ssc-ild
Who may be able to join
- -
Who cannot join
- ssc without ild
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University of patras
Pátrai
University of patraS SNL, PROF, +30 697 7066105, snliossis@med.upatras.gr
stephanie erotokritou, MD
About this study
Patients with ssc-ild receiving double immunosuppression with or without anti fibrotic tratment
Read the 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.
- Conditions
- SSc-Systemic Sclerosis
- Being tested
- Antifibrotic drugs (nidanib or pirfenidone), MMF Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antifibrotic drugs (nidanib or pirfenidone)Drug
Ssc - ild
MMF ImmunosuppressionDrug
Also called RITUXIMAB
we will compare patients with SSc-ILD taking RTX and mmf and patients that are taking RTX,mmf and nintedanib
| Study group | Role | What they receive |
|---|---|---|
| Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic | Comparison of the two groups Receives: Drug: Antifibrotic drugs (nidanib or pirfenidone); Drug: MMF Immunosuppression | |
| Patient with ssc-ild with a double immunosuppression treatment only | Patients with rituximab and mmf Receives: Drug: MMF Immunosuppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment till the end of study -1 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Jun 2025
- Primary completionJul 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SSc-Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liossis Stamatis Nick, University of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491523
- Sponsor's protocol ID
- University of Patra
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
- ClinicalTrials.gov ID
- NCT07491523
- Acronym / sponsor ID
- University of Patra
- Conditions
- SSc-Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with ssc-ild receiving double immunosuppression with or without anti fibrotic tratment
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic | – | Drug: Antifibrotic drugs (nidanib or pirfenidone), Drug: MMF ImmunosuppressionComparison of the two groups |
| Patient with ssc-ild with a double immunosuppression treatment only | – | Drug: MMF ImmunosuppressionPatients with rituximab and mmf |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ssc-ild
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- ssc without ild
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antifibrotic drugs (nidanib or pirfenidone)Ssc - ild | Drug | Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic |
| MMF ImmunosuppressionAlso: RITUXIMABwe will compare patients with SSc-ILD taking RTX and mmf and patients that are taking RTX,mmf and nintedanib | Drug | Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic, Patient with ssc-ild with a double immunosuppression treatment only |
Primary outcome
pulmonary function test
Time frame: From enrollment till the end of study -1 years later
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SSc-Systemic Sclerosis, run by University of Patras at 1 site in Greece.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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 Greece. 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?
Contact Stamatis Nick Liossis C Professor, MD, PhD (+306977066105, snliossis@med.upatras.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function test (time frame: From enrollment till the end of study -1 years later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.