The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.
Men or women aged 18-74 at the date of signing the informed consent.
Written informed consent in accordance with the International Harmonization Guidelines Harmonized Tripartite: Guidelines for Good Clinical Practice (ICH-GCP) and local regulations signed before any study procedure.
Documented diagnosis of systemic sclerosis according to the criteria of the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (former name - European League Against Rheumatism) - EULAR, meeting the criteria of active disease [patients with limited and diffused SSc)] and with an overall disease duration of less than or equal to (≤ 72 months).
Patients with interstitial lung disease (ILD) confirmed by HRCT (min. 10% lung involvement).
Patients not fully capable of giving informed consent.
Pregnant or breastfeeding women.
Major surgery within 8 weeks before screening (W0A).
Rheumatic disease other than systemic sclerosis (systemic lupus erythematosus, rheumatoid arthritis, mixed connective tissue disease). Diagnosis of secondary Sjögren's syndrome is acceptable.
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Lead sponsor
Medical Research Agency, Poland
Collaborator