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COMPLETED
NCT00479934
PHASE2

Efficacy and Safety of Imatinib in Scleroderma

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

DRUG

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