Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related arthritis, too. This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to: * investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and * to validate the CDAI for arthritis in systemic sclerosis.
Study Type
OBSERVATIONAL
Enrollment
160
University of Ghent, Department of Rheumatology
Ghent, Belgium
RECRUITINGDubrava University Hospital
Zagreb, Croatia
RECRUITINGAssiut and Sohage University Hospital Rheumatology Department Assiut University Hospital
Asyut, Egypt
RECRUITINGDepartment of Internal Medicine Hôpital Claude Huriez
Lille, France
Improvement of HAQ-DI (CHAQ-DI in jSSc) by at least -0.21 in one year
Improvement from baseline in Health Assessment Questionnaire - Disability Index (Child Health Assessment Questionnaire - Disability Index in juvenile systemic sclerosis) by at least -0,21(moderate improvement) in one year
Time frame: 12 months
Improvement of the CHFS in one year
Improvement of the Cochin Hand Function Scale in one year
Time frame: 12 months
Improvement of the CDAI in one year
Improvement of the Clinical Disease Activity Index in one year
Time frame: 12 months
Improvement of the SDAI in one year
Improvement of the Simplified Disease Activity Index in one year
Time frame: 12 months
Improvement of the DAS28(We) in one year
Improvement of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in one year
Time frame: 12 months
Improvement of the DAS28(CRP) in one year
Improvement of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in one year
Time frame: 12 months
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Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, France
RECRUITINGJustus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, Germany
RECRUITINGCharité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, Germany
RECRUITINGUniversitätshautklinik Köln
Cologne, Germany
RECRUITINGUniversitätsklinikum Erlangen
Erlangen, Germany
RECRUITINGEndokrinologikum Frankfurt
Frankfurt, Germany
RECRUITING...and 23 more locations