Arthritis, Systemic Sclerosis
Conditions
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.
Interventions
None listed
Sponsors
European Union
University of Giessen
University of Zurich
University of Paris 5 - Rene Descartes
University of Florence
University of Campania Luigi Vanvitelli
University of Basel
University College, London
Charite University, Berlin, Germany
University of Leeds
Schoen Klinik Hamburg Eilbek
Prof. Laszlo Czirjak
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Validation of the CDAI in systemic sclerosis | 12 months | Exploratory endpoint: Validation of the Clinical Disease Activity Index in systemic sclerosis |
| Incidence of withdrawal from treatment due to drug-related adverse events | 24 months | Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events |
| Validation of the SDAI in systemic sclerosis | 12 months | Exploratory endpoint: Validation of the Simplified Disease Activity Index in systemic sclerosis |
| Validation of the DAS28(ESR) in systemic sclerosis | 12 months | Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in systemic sclerosis |
| Validation of the DAS28(CRP) in systemic sclerosis | 12 months | Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in systemic sclerosis |
| Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis | 24 months | Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis |
| Incidence of drug-related adverse events | 24 months | Evaluation of the incidence of drug-related adverse events |
Countries
Belgium, Croatia, Egypt, France, Germany, Hungary, Italy, Romania, Russia, Serbia, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Contacts
Primary ContactLaszlo Czirjak, Prof.
Outcome results
None listed