Clinical Trial: Efficacy and Safety of Imatinib in Scleroderma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Same as current

Current Secondary Outcome:

  • Compare efficacy of imatinib mesylate vs placebo based on the percent variation of modified Rodnan score between the inclusion and the various time points of follow-up. [ Time Frame: 1, 3 and 12 month ]
  • Assess skin thickness at inclusion and at 6 months using skin biopsies [ Time Frame: 6 month ]
  • Assessment of quality of life using DLQI (Dermatology Quality of Life Index) and HAQ (Health Assessment Questionnaire). [ Time Frame: At 1, 3, 6 month and 1 year, ]
  • Assess tolerance of treatment (clinical and laboratory monitoring of side effects) [ Time Frame: All along the trial ]
  • Assess effects of treatment on non cutaneous symptoms in systemic sclerosis patients [ Time Frame: All along the trial ]


Original Secondary Outcome:

  • Compare efficacy of imatinib mesylate vs placebo based on the percent variation of modified Rodnan score between the inclusion and the various time points of follow-up.
  • Assess skin thickness at inclusion and at 6 months using skin biopsies
  • At 1, 3, 6 and 1 year, assessment of quality of life using DLQI (Dermatology Quality of Life Index) and HAQ (Health Assessment Questionnaire).
  • Assess tolerance of treatment (clinical and laboratory monitoring of side effects)
  • Assess effects of treatment on non cutaneous symptoms in systemic sclerosis patients


Information By: University Hospital, Bordeaux

Dates:
Date Received: May 29, 2007
Date Started: December 2007
Date Completion:
Last Updated: March 3, 2011
Last Verified: March 2011