Clinical Trial: Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

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 Summary: 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.
Sponsor: University of Manchester

Current Primary Outcome: Skin score as measured by modified rodnan skin score [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP) [ Time Frame: 24 months ]
  • Echocardiographic findings [ Time Frame: 24 months ]
  • Cochin hand function [ Time Frame: 24 months ]
  • Fatigue as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) scale [ Time Frame: 24 months ]
  • Short form 36 questionnaire (SF-36) [ Time Frame: 24 months ]
  • Scleroderma Health Assessment Questionnaire [ Time Frame: 24 months ]
  • Haemoglobin [ Time Frame: 24 months ]
  • Erythrocyte sedimentation rate [ Time Frame: 24 months ]
  • Estimated glomerular filtration rate (eGFR) [ Time Frame: 24 months ]


Original Secondary Outcome:

  • Pulmonary function as measured by right ventricular systolic pressure (RVSP) or pulmonary artery pressure (PAP) [ Time Frame: 24 months ]
  • Echocardiograhic findings [ Time Frame: 24 months ]
  • Cochin hand function [ Time Frame: 24 months ]
  • Fatigue as measured by the FACIT fatigue scale [ Time Frame: 24 months ]
  • Short form 36 questionnaire (SF-36) [ Time Frame: 24 months ]
  • Scleroderma Health Assessment Questionnaire [ Time Frame: 24 months ]
  • Haemoglobin [ Time Frame: 24 months ]
  • Erythrocyte sedimentation rate [ Time Frame: 24 months ]
  • Estimated glomerular filtration rate (eGFR) [ Time Frame: 24 months ]


Information By: University of Manchester

Dates:
Date Received: December 22, 2014
Date Started: June 2010
Date Completion:
Last Updated: May 12, 2016
Last Verified: May 2016