M34
Conditions
Interventions
Group 1: We will re-use the Data from the EUSTAR (European Scleroderma Trial and Research) database. SSc patients, treated with Tocilizumab: The aim of this project is to evaluate the outcomes of SSc-
Sponsors
F.Hoffmann- La Roche Ltd
Eligibility
Sex/Gender
All
Age
17 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age greater or equal 17 years - Observations of patients entering the database after 1.1.2010 - Classification criteria for SSc fulfilled (ACR 1980 criteria or 2013 ACR/EULAR criteria) - Potential control patients with disease duration less or equal 35 years
Exclusion criteria
Exclusion criteria: Not signed or withdrawn informed consent for EUSTAR database
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are mRSS (modified Rodnan Skin Score) and FVC, both at 12 months follow-up time. The time window for the 12 months assessment will be a 9-15 months window. The two different endpoints will be addressed separately, but a single matched set of patient case-control pairs will be used for analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of progressive patients for skin under therapy, defined as an increase in (mRSS of 5 points AND of 25% compared to baseline). The percentage of progressive patients for lung under therapy, defined as a decrease in either (FVC > 10%) or (FVC >5% AND DLCO > 15%). | — |
Countries
Switzerland
Contacts
Public ContactSuzana Jordan
Klinik für RheumatologieUniversitätsspital Zürich
Outcome results
None listed