Efficacy and Safety of Imatinib in Scleroderma

Study acronym: SCLEROGLIVEC
StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Study Status, Sponsor/Collaborators, Referencesv6
  2. Study completion date changed from estimate of Dec 2009 to Dec 2010v5 Show 4 more changesShow less
    • Trial status: Recruiting to Completed
    • Enrollment target: estimated 34 to confirmed 28
    • Primary completion date changed from estimate of Dec 2009 to Jun 2010
    • Site details revised at 12 of 12 sites
  3. Re-verified, no change to tracked fieldsv4
  4. Study sites: 7 to 12
    • Secondary endpoints revised (5)
    • Study arms: 0 to 2
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Jul 2007 to Dec 2007
    • Primary completion date: Dec 2009
    • Study completion date: Aug 2009 to Dec 2009
    • Site details revised at 7 of 7 sites
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In vitro studies have shown that imatinib 1mM inhibits strongly the growth of cutaneous fibroblasts. The hypothesis is that imatinib inhibits PDGFR which is known to be a potential target for the molecule, as recently also proposed after the discovery of autoantibodies activating the PDGF receptors. Recent data indicate that TGFb is also a potential target of imatinib. Cutaneous scleroderma is characterized by progressive cutaneous fibrosis caused by hyperactive dermal fibroblasts. Since no established treatment for skin sclerosis in scleroderma is currently available. This study will test the safety and efficacy of imatinib in the treatment of patients with scleroderma and severe cutaneous involvement.
Trial Details
NCT Number NCT00479934
Lead Sponsor University Hospital, Bordeaux
Collaborators: Ministry of Health, France, Novartis
Conditions
(from sponsor)		 Scleroderma, Localized, Scleroderma, Systemic
Related terms Scleroderma, Diffuse, Scleroderma, Localized, Scleroderma, Systemic
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov