Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis
- Conditions
- Early Diffuse Cutaneous Systemic Sclerosis
- Interventions
- Registration Number
- NCT02339441
- Lead Sponsor
- University of Manchester
- Brief Summary
The aim of the study is to compare the effectiveness of commonly used immunosuppressant treatments for early diffuse cutaneous systemic sclerosis (SSc).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
Age > 18 Skin thickening < 3 years Immunosuppressant use < 4 months Proximal skin involvement to face/neck, elbow or knee
Previous use of more than 4 months of methotrexate, mycophenolate mofetil, cyclophosphamide or other immunosuppressive treatments
Previous use of immunosuppressant therapy other than methotrexate, mycophenolate mofetil or cyclophosphamide within previous months
Previous stem cell transplantation therapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Methotrexate Methotrexate Patients treated with Methotrexate at the entry of the study. Mycophenolate Mofetil Mycophenolate mofetil Patients treated with Mycophenolate Mofetil at the entry of the study. Cyclophosphamide Cyclophosphamide Patients treated with Cyclophosphamide at the entry of the study
- Primary Outcome Measures
Name Time Method Skin score as measured by modified rodnan skin score 24 months
- Secondary Outcome Measures
Name Time Method Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP) 24 months Echocardiographic findings 24 months Cochin hand function 24 months Fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) scale 24 months Short form 36 questionnaire (SF-36) 24 months Scleroderma Health Assessment Questionnaire 24 months Haemoglobin 24 months Erythrocyte sedimentation rate 24 months Estimated glomerular filtration rate (eGFR) 24 months