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Efficacy and Safety of Imatinib in Scleroderma

NCT00479934 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Scleroderma, Localized
  • Scleroderma, Systemic

Interventions

DRUG

imatinib mesylate

6 month treatment with 400mg/day (per os)

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Novartis

    collaborator INDUSTRY

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Alain TAIEB, Pr. · University Hospital, Bordeaux, France

  • Geneviève CHENE, Pr · University Hospital, Bordeaux, France

  • Alian TAIEB, Pr. · University Hospital, Bordeaux, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-06-30
Completion
2010-12-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479934 on ClinicalTrials.gov