Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

Prof. Laszlo Czirjak

Status: Unknown

Conditions: Arthritis; Systemic Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT01834157

HEALTH-F5-2012-305495-OT2

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

160 participants in 7 patient groups

methotrexate

Description:

methotrexate with or without low-dose corticosteroids

other DMARDs

Description:

other DMARDs (leflunomide, azathioprine, mycophenolate mofetil) with or without low-dose corticosteroids

low-dose corticosteroids

Description:

low-dose corticosteroids without DMARDs

No DMARD or corticosteroids

Description:

No DMARD or corticosteroid treatment

CPH/CSA - Exploratory cohort

Description:

cyclophosphamide or cyclosporine-A with or without other DMARDs or low-dose corticosteroids

Biologics - Exploratory cohort

Description:

Biologic therapy with or without other DMARDs or low-dose corticosteroids

Combinations - Exploratory cohort

Description:

Combination of two or more DMARDs with or without low-dose corticosteroids