Multicentre Clinical Trial Evaluating the Safety and Efficacy of the Combination of Nintedanib+Tocilizumab Compared to Standard Treatment in Patients With Systemic Sclerosis and Interstitial Lung Disease. Analysis With Theranostic Approach
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).
• Evaluation of skin induration with the modified Rodnan skin score (mRSS) from 10 to 45 units inclusive.
• Patients treated with conventional drugs such as mycophenolate mofetil, methotrexate; should be on stable doses for ≥ 8 weeks before and including the screening visit (W0).
• Patients may be treated with standard therapy, but no new therapy or withdrawal of therapy within 8 weeks before the first screening visit (W0).
• Patients taking oral glucocorticosteroids (GCS) should be on a stable dose of ≤ 10 mg/day prednisone or equivalent for at least 8 weeks before the baseline visit.
• Patients of childbearing potential should agree to abstain from sexual activity or use a highly effective method of contraception throughout the study and for at least 3 months after the last dose of medicinal products.