Scleroderma is a rare, chronic disease of the immune system, blood vessels and connective tissue. The disease can affect the skin, joints, tendons and in more severe forms the internal organs, causing them to be unable to function normally. Early diffuse cutaneous systemic sclerosis is a type of scleroderma. It affects the internal organs as well as the skin. Common symptoms include fatigue, joint pain and stiffness. Click here for more information.
what is the purpose of this study?
The aim of this study is to test if prednisolone, a corticosteroid widely prescribed in the UK and internationally, helps patients with systemic sclerosis. We want to find out if prednisolone therapy for 6 months can help relieve the severe pain, itching, and disability of early diffuse systemic sclerosis.
Patients will be eligible for inclusion into the study if they have been diagnosed with early diffuse systemic sclerosis within the last 3 years. Patients will be placed into two separate treatment groups at random. One group will receive prednisolone, the other group will receive the placebo (or “dummy drug”). Patients will take the prescribed medication for a total of 6 months. The results will be compared to see if one treatment is better than the other. Neither the patient nor the doctor will know which treatment group patients are in.
Manchester Clinical Trials Unit (MCTU) will process the data and perform statistical analysis. The results will then be analysed by a team of researchers at the University of Manchester.
For more information about what’s involved in the study, click here.