NCT01834157

Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

The "DeSScipher" Project - to Decipher the Best Treatment for Systemic Sclerosis - Observational Trial 2: Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Prof. Laszlo Czirjak · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2013-04-17
• Last updated: 2015-12-22

Locations

33 sites across 14 countries: Belgium, Croatia, Egypt, France, Germany, Hungary, Italy, Romania, Russia, Serbia, Spain, Switzerland, Turkey (Türkiye), United Kingdom