Arthritis Clinical Trial
Official title:
The "DeSScipher" Project - to Decipher the Best Treatment for Systemic Sclerosis - Observational Trial 2: Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - Presence of significant, long standing articular pain due to other cause than autoimmune disease - Presence of hand disability caused by other, than autoimmune disease |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | University of Ghent, Department of Rheumatology | Gent | |
Croatia | Dubrava University Hospital | Zagreb | |
Egypt | Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital | Assiut | |
France | Department of Internal Medicine Hôpital Claude Huriez | Lille cedex | |
France | Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016 | Paris | |
Germany | Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology | Bad Nauheim | |
Germany | Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie | Berlin | |
Germany | Universitätshautklinik Köln | Cologne | |
Germany | Universitätsklinikum Erlangen | Erlangen | |
Germany | Endokrinologikum Frankfurt | Frankfurt | |
Germany | Centre for Pediatric Rheumatology, Klinikum Eilbek | Hamburg | |
Germany | Medizinische Universitätsklinik Abt. II | Tübingen | |
Germany | Krankenhaus St. Josef | Wuppertal | |
Hungary | Pecsi Tudomanyegyetem - University of Pecs | Pecs | |
Italy | Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona | Ancona | |
Italy | University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine | Firenze | |
Italy | Department of Rheumatology, University of Cagliari-Policlinico Universitario | Monserrato | |
Italy | Policlinico, Via Pansini | Napoli-Italia | |
Italy | University of Padova | Padova | |
Italy | Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I | Roma | |
Romania | Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital | Bucharest | |
Romania | Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj | Cluj-Napoca | |
Romania | GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital | Iasi | |
Russian Federation | Clinic of Nephrology, Internal and Occupational Diseases | Moscow | |
Russian Federation | Institute of Rheumatology, Russian Academy of Medical Science | Moscow | |
Serbia | Institute of Rheumatology Belgrade | Belgrade | |
Spain | Hospital Universitario Madrid Norte Sanchinarro | Madrid | |
Switzerland | Felix-Platter Spital | Basel | |
Switzerland | University of Zurich, Department of Rheumatology | Zurich | |
Turkey | University of Marmara, Department of Rheumatology | Istanbul | |
United Kingdom | The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital | Leeds | |
United Kingdom | Royal Free Hospital, University College London | London | |
United Kingdom | University of Manchester, Rheumatic Diseases Centre, Clinical Sciences | Manchester,Salford |
Lead Sponsor | Collaborator |
---|---|
Prof. Laszlo Czirjak | Charite University, Berlin, Germany, European Union, Schoen Klinik Hamburg Eilbek, Second University of Naples, University College, London, University of Basel, University of Florence, University of Giessen, University of Leeds, University of Paris 5 - Rene Descartes, University of Zurich |
Belgium, Croatia, Egypt, France, Germany, Hungary, Italy, Romania, Russian Federation, Serbia, Spain, Switzerland, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Validation of the CDAI in systemic sclerosis | Exploratory endpoint: Validation of the Clinical Disease Activity Index in systemic sclerosis | 12 months | No |
Other | Validation of the SDAI in systemic sclerosis | Exploratory endpoint: Validation of the Simplified Disease Activity Index in systemic sclerosis | 12 months | No |
Other | Validation of the DAS28(ESR) in systemic sclerosis | Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in systemic sclerosis | 12 months | No |
Other | Validation of the DAS28(CRP) in systemic sclerosis | Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in systemic sclerosis | 12 months | No |
Other | Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis | Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis | 24 months | No |
Other | Incidence of drug-related adverse events | Evaluation of the incidence of drug-related adverse events | 24 months | Yes |
Other | Incidence of withdrawal from treatment due to drug-related adverse events | Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events | 24 months | Yes |
Primary | 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 | 12 months | No |
Secondary | Improvement of the CHFS in one year | Improvement of the Cochin Hand Function Scale in one year | 12 months | No |
Secondary | Improvement of the CDAI in one year | Improvement of the Clinical Disease Activity Index in one year | 12 months | No |
Secondary | Improvement of the SDAI in one year | Improvement of the Simplified Disease Activity Index in one year | 12 months | No |
Secondary | 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 | 12 months | No |
Secondary | 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 | 12 months | No |
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