Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
- Conditions
- Systemic SclerosisArthritis
- Registration Number
- NCT01834157
- Lead Sponsor
- Prof. Laszlo Czirjak
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- Juvenile and adult Systemic sclerosis patients, with diagnosis according to the ACR/EULAR adult SSc criteria and PRES/ACR/EULAR juvenile SSc criteria respectively
- Clinical signs of arthritis (defined as ≥2 tender and swollen joints)
- Presence of significant, long standing articular pain due to other cause than autoimmune disease
- Presence of hand disability caused by other, than autoimmune disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of HAQ-DI (CHAQ-DI in jSSc) by at least -0.21 in one year 12 months 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
- Secondary Outcome Measures
Name Time Method Improvement of the CHFS in one year 12 months Improvement of the Cochin Hand Function Scale in one year
Improvement of the CDAI in one year 12 months Improvement of the Clinical Disease Activity Index in one year
Improvement of the SDAI in one year 12 months Improvement of the Simplified Disease Activity Index in one year
Improvement of the DAS28(We) in one year 12 months Improvement of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in one year
Improvement of the DAS28(CRP) in one year 12 months Improvement of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in one year
Trial Locations
- Locations (33)
Universitätshautklinik Köln
🇩🇪Cologne, Germany
Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona
🇮🇹Ancona, Italy
University of Manchester, Rheumatic Diseases Centre, Clinical Sciences
🇬🇧Manchester,Salford, United Kingdom
Dubrava University Hospital
🇭🇷Zagreb, Croatia
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Krankenhaus St. Josef
🇩🇪Wuppertal, Germany
University of Padova
🇮🇹Padova, Italy
Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital
🇪🇬Assiut, Egypt
Pecsi Tudomanyegyetem - University of Pecs
🇭🇺Pecs, Hungary
Policlinico, Via Pansini
🇮🇹Napoli-Italia, Italy
Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital
🇷🇴Bucharest, Romania
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
🇫🇷Paris, France
Medizinische Universitätsklinik Abt. II
🇩🇪Tübingen, Germany
Department of Internal Medicine Hôpital Claude Huriez
🇫🇷Lille cedex, France
University of Ghent, Department of Rheumatology
🇧🇪Gent, Belgium
Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I
🇮🇹Roma, Italy
GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital
🇷🇴Iasi, Romania
University of Zurich, Department of Rheumatology
🇨🇭Zurich, Switzerland
Felix-Platter Spital
🇨🇭Basel, Switzerland
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
🇩🇪Bad Nauheim, Germany
Department of Rheumatology, University of Cagliari-Policlinico Universitario
🇮🇹Monserrato, Italy
Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj
🇷🇴Cluj-Napoca, Romania
University of Marmara, Department of Rheumatology
🇹🇷Istanbul, Turkey
Endokrinologikum Frankfurt
🇩🇪Frankfurt, Germany
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
🇮🇹Firenze, Italy
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
🇬🇧Leeds, United Kingdom
Clinic of Nephrology, Internal and Occupational Diseases
🇷🇺Moscow, Russian Federation
Hospital Universitario Madrid Norte Sanchinarro
🇪🇸Madrid, Spain
Institute of Rheumatology, Russian Academy of Medical Science
🇷🇺Moscow, Russian Federation
Institute of Rheumatology Belgrade
🇷🇸Belgrade, Serbia
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
🇩🇪Berlin, Germany
Centre for Pediatric Rheumatology, Klinikum Eilbek
🇩🇪Hamburg, Germany
Royal Free Hospital, University College London
🇬🇧London, United Kingdom