Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

• Conditions: Systemic Sclerosis; Arthritis

• 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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-13
• Study First Posted: 2013-04-17
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

• 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)

University of Ghent, Department of Rheumatology; 🇧🇪 Gent, Belgium

Dubrava University Hospital; 🇭🇷 Zagreb, Croatia

Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital; 🇪🇬 Assiut, Egypt

Department of Internal Medicine Hôpital Claude Huriez; 🇫🇷 Lille cedex, France

Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016; 🇫🇷 Paris, France

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

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