Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01834157
• Other study ID #: HEALTH-F5-2012-305495-OT2
• Status: Recruiting
• Phase: N/A
• First received: April 9, 2013
• Last updated: December 21, 2015
• Start date: April 2013
• Est. completion date: November 2017

Study information

• Verified date: December 2015
• Source: University of Pecs
• Contact: Laszlo Czirjak, Prof.
• Email: laszlo.czirjak[@]aok.pte.hu
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeGermany: Ethics CommissionHungary: Institutional Ethics CommitteeFrance: Institutional Ethical CommitteeSwitzerland: EthikkommissionUnited Kingdom: Research Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

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

Sponsors (12)

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

Countries where clinical trial is conducted

Belgium,  Croatia,  Egypt,  France,  Germany,  Hungary,  Italy,  Romania,  Russian Federation,  Serbia,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

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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