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Efficacy and Safety of Imatinib in Scleroderma
Sponsor: University Hospital, Bordeaux
Summary
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.
Official title: Phase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2007-12
Completion Date
2010-12
Last Updated
2026-05-14
Healthy Volunteers
No
Interventions
imatinib mesylate
6 month treatment with 400mg/day (per os)
Locations (12)
Service de Dermatologie et services de médecine interne et vasculaire - Hôpital St André - CHU de Bordeaux
Bordeaux, France
Service de Rhumatologie, Hôpital Pellegrin-Tondu CHU de Bordeaux
Bordeaux, France
Service de Dermatologie - CHG Libourne
Libourne, France
Service de dermatologie - CHU de Limoges
Limoges, France
Service de Médecin interne - Hôpital central
Nancy, France
Service de Médecine interne - Hôpital Saint Louis
Paris, France
Service de Dermatologie - service de médecine interne et vasculaire - hopital haut Lévêque - av.de magellan
Pessac, France
Service de Dermatologie - CHG Périgueux
Périgueux, France
Service de Rhumatologie - CHU de Strasbourg
Strasbourg, France
Service de Dermatologie - CHU de Toulouse - Hopital Purpan
Toulouse, France
Service de Médecine interne - CHU de Tours
Tours, France
Néphrologie et Médecine interne - CH de Valenciennes
Valenciennes, France