Clinical trial NCT01834157: Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Arthritis
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: European Union
name: University of Giessen
name: University of Zurich
name: University of Paris 5 - Rene Descartes
name: University of Florence
name: University of Campania Luigi Vanvitelli
name: University of Basel
name: University College, London
name: Charite University, Berlin, Germany
name: University of Leeds
name: Schoen Klinik Hamburg Eilbek
First posted: 2013-04-17
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement of HAQ-DI (CHAQ-DI in jSSc) by at least -0.21 in one year
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of the CHFS in one year
timeFrame: 12 months
measure: Improvement of the CDAI in one year
timeFrame: 12 months
measure: Improvement of the SDAI in one year
timeFrame: 12 months
measure: Improvement of the DAS28(We) in one year
timeFrame: 12 months
measure: Improvement of the DAS28(CRP) in one year
timeFrame: 12 months
Other outcomes:
measure: Validation of the CDAI in systemic sclerosis
timeFrame: 12 months
measure: Validation of the SDAI in systemic sclerosis
timeFrame: 12 months
measure: Validation of the DAS28(ESR) in systemic sclerosis
timeFrame: 12 months
measure: Validation of the DAS28(CRP) in systemic sclerosis
timeFrame: 12 months
measure: Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis
timeFrame: 24 months
measure: Incidence of drug-related adverse events
timeFrame: 24 months
measure: Incidence of withdrawal from treatment due to drug-related adverse events
timeFrame: 24 months
Locations:
city: Gent
country: Belgium
facility: University of Ghent, Department of Rheumatology
city: Zagreb
country: Croatia
facility: Dubrava University Hospital
city: Assiut
country: Egypt
facility: Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital
city: Lille cedex
country: France
facility: Department of Internal Medicine Hôpital Claude Huriez
city: Paris
country: France
facility: Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
city: Bad Nauheim
country: Germany
facility: Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
city: Cologne
country: Germany
facility: Universitätshautklinik Köln
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Frankfurt
country: Germany
facility: Endokrinologikum Frankfurt
city: Hamburg
country: Germany
facility: Centre for Pediatric Rheumatology, Klinikum Eilbek
city: Tübingen
country: Germany
facility: Medizinische Universitätsklinik Abt. II
city: Wuppertal
country: Germany
facility: Krankenhaus St. Josef
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem - University of Pecs
city: Ancona
country: Italy
facility: Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona
city: Firenze
country: Italy
facility: University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
city: Monserrato
country: Italy
facility: Department of Rheumatology, University of Cagliari-Policlinico Universitario
city: Napoli-Italia
country: Italy
facility: Policlinico, Via Pansini
city: Padova
country: Italy
facility: University of Padova
city: Roma
country: Italy
facility: Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I
city: Bucharest
country: Romania
facility: Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital
city: Cluj-Napoca
country: Romania
facility: Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj
city: Iasi
country: Romania
facility: GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital
city: Moscow
country: Russian Federation
facility: Clinic of Nephrology, Internal and Occupational Diseases
city: Moscow
country: Russian Federation
facility: Institute of Rheumatology, Russian Academy of Medical Science
city: Belgrade
country: Serbia
facility: Institute of Rheumatology Belgrade
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Norte Sanchinarro
city: Basel
country: Switzerland
facility: Felix-Platter Spital
city: Zurich
country: Switzerland
facility: University of Zurich, Department of Rheumatology
city: Istanbul
country: Turkey
facility: University of Marmara, Department of Rheumatology
city: Leeds
country: United Kingdom
facility: The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital, University College London
city: Manchester,Salford
country: United Kingdom
facility: University of Manchester, Rheumatic Diseases Centre, Clinical Sciences
Study officials:
affiliation: Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
name: Ulf Müller-Ladner, Prof.
role: STUDY_CHAIR
affiliation: PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS
name: Laszlo Czirjak, Prof
role: PRINCIPAL_INVESTIGATOR
References: