Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

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.

Conditions

• Systemic Sclerosis
• Arthritis

Sponsors & Collaborators

• European Union

  collaborator OTHER

• University of Giessen

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• University of Paris 5 - Rene Descartes

  collaborator OTHER

• University of Florence

  collaborator OTHER

• University of Campania Luigi Vanvitelli

  collaborator OTHER

• University of Basel

  collaborator OTHER

• University College, London

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• Schoen Klinik Hamburg Eilbek

  collaborator OTHER

• Prof. Laszlo Czirjak

  lead OTHER

Principal Investigators

• Ulf Müller-Ladner, Prof. · Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

• Laszlo Czirjak, Prof · PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2017-11-30

Completion

2017-11-30

Countries

• Belgium
• Croatia
• Egypt
• France
• Germany
• Hungary
• Italy
• Romania
• Russia
• Serbia
• Spain
• Switzerland
• Turkey (Türkiye)
• United Kingdom

Study Locations