Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD

NCT07491523 | Recruiting FDA Drug

• 1 other identifier: University of Patra
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

SSc-Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic

Comparison of the two groups

Drug: Antifibrotic drugs (nidanib or pirfenidone); Drug: MMF Immunosuppression

Patient with ssc-ild with a double immunosuppression treatment only

Patients with rituximab and mmf

Drug: MMF Immunosuppression

Interventions

Antifibrotic drugs (nidanib or pirfenidone) DRUG

Ssc - ild

Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic

MMF Immunosuppression DRUG

we will compare patients with SSc-ILD taking RTX and mmf and patients that are taking RTX,mmf and nintedanib

Also known as: RITUXIMAB

Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic; Patient with ssc-ild with a double immunosuppression treatment only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ssc-ild

You may not qualify if:

• ssc without ild

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

University of patras

Pátrai, Greece

RECRUITING

MeSH Terms

Interventions

pirfenidone; Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Stamatis Nick Liossis C Professor, MD, PhD

CONTACT

+306977066105; snliossis@med.upatras.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 24, 2026
• Study Start: June 1, 2025
• Primary Completion: July 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

GR (1)