The subject of the contract is comprehensive supervision over the implementation of a clinical trial under the project: Multicenter clinical trial evaluating the safety and efficacy of combined treatment of nintedanib and tocilizumab compared to standard treatment in patients with systemic sclerosis and interstitial lung disease. Analysis with theranostic approach and assessment of cytokine activity, markers of pulmonary inflammation and fibrosis using computed tomography, positron emission tomography, metabolome and transcriptome studies in selected patients. The project is financed by the Medical Research Agency (Grant Agreement No. 2022/ABM/01/00004-00). A detailed description of the subject matter of the contract is included in the Terms of Reference and Appendix No. 2 – description of the subject matter of the contract and Appendix No. 3 – draft contract,

The subject of the contract is comprehensive supervision over the implementation of a clinical trial under the project: Multicenter clinical trial evaluating the safety and efficacy of combined treatment of nintedanib and tocilizumab compared to standard treatment in patients with systemic sclerosis and interstitial lung disease. Analysis with theranostic approach and assessment of cytokine activity, markers of pulmonary inflammation and fibrosis using computed tomography, positron emission tomography, metabolome and transcriptome studies in selected patients. The project is financed by the Medical Research Agency (Grant Agreement No. 2022/ABM/01/00004-00). The scope of the Order includes:

Comprehensive support of a clinical trial including monitoring, supervision of the implementation, safety and data of a clinical trial planned as part of the project "Multicenter clinical trial to evaluate the safety and efficacy of combined treatment of nintedanib and tocilizumab compared to standard treatment in patients with systemic sclerosis and interstitial lung disease. Theranostic analysis and assessment of cytokine activity, markers of pulmonary inflammation and fibrosis using computed tomography, positron emission tomography, metabolome and transcriptome studies, hereinafter referred to as the "Study", in accordance with the Good Clinical Practice guidelines of the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the European Medicines Agency, the Declaration of Helsinki and applicable legislation, including:

Management, organization and conduct of the survey in:

the Eleonora Reicher National Institute of Geriatrics, Rheumatology and Rehabilitation in Warsaw;

Department of Rheumatology and Clinic of Pulmonology and Allergology of the Medical University of Lodz, al. Kościuszki 4, 90-419 Łódź;

Department of Rheumatology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary,

“Carol Davila” University of Medicine and Pharmacy Department of Internal Medicine and Rheumatology, “Sf. Maria” Hospital Bucharest Romania, Bukareszt, Rumunia.