|The aim of the study
Diffuse cutaneous systemic sclerosis (SSc) is a rare autoimmune disease characterised by excessive connective tissue in the skin (causing skin thickening called ‘scleroderma’), muscle, joints and internal organs. A number of different drugs with effects on the immune system (known as ‘immunosuppressants’) are currently being used by clinicians in the treatment of early diffuse cutaneous SSc, but all can have significant side effects. We want to know whether any one is definitely effective and, if so, which is the most effective.
Patients will be eligible for inclusion into the study if skin thickening is less than 3 years duration. Treatment, in all cases, will be decided by clinicians and patients as per usual clinical practice. ESOS will observe patients receiving methotrexate, mycophenolate mofetil and cyclophosphamide as well as patients who receive no immunosuppressant treatment.
Following informed consent, each patient is followed up at set time points for 12 –24 months in line with good clinical practice. Data is entered via a secure web-based data entry system. This is a ‘real life’ approach: a patient may change therapy within the study if, for example, s/he develops side effects to the first treatment. The data will then be analysed by a team of statisticians at the University of Manchester.