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Efficacy and Safety of Imatinib in Scleroderma (SCLEROGLIVEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00479934
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : March 4, 2011
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux

Brief 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.

Condition or disease Intervention/treatment Phase
Scleroderma, Localized Scleroderma, Systemic Drug: imatinib mesylate Phase 2

Detailed Description:
This study will test the efficacy and tolerance of patients with a high score of induration (modified Rodnan score > 20/54) Comparison : 34 patients with severe forms of cutaneous involvement will be evaluated in a double blind RCT comparing imatinib 400mg/j and placebo in a 6 month period. Efficacy will be assessed using a cutaneous induration scale and skin biopsy, and quality of life questionnaires.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : December 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1
6 month treatment with Imtinib 400mg/day
Drug: imatinib mesylate
6 month treatment with 400mg/day (per os)

Placebo Comparator: 2
6 month treatment with Placebo 400mg/day
Drug: imatinib mesylate
6 month treatment with 400mg/day (per os)

Primary Outcome Measures :
  1. Compare the efficacy of imatinib mesylate vs placebo based on the percent variation of modified Rodnan score (0-51) between inclusion and 6-month visits. [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. 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 ]
  2. Assess skin thickness at inclusion and at 6 months using skin biopsies [ Time Frame: 6 month ]
  3. 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, ]
  4. Assess tolerance of treatment (clinical and laboratory monitoring of side effects) [ Time Frame: All along the trial ]
  5. Assess effects of treatment on non cutaneous symptoms in systemic sclerosis patients [ Time Frame: All along the trial ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • More than 18 years old
  • Documented diagnostic of scleroderma (systemic or cutaneous)
  • Severe cutaneous sclerodermia or systemic sclerodermia with m-Rodnan score > 20/51
  • Ejection fraction of more than 45 per cent at cardiac ultrasound pre-inclusion study
  • Woman with efficient contraceptive method during trail treatment and during 3 month after the end of trial treatment
  • All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrolment
  • Affiliated or profit patient of a social security system
  • Signed informed consent

Exclusion Criteria:

  • new systemic treatment, potentially interfering with disease progression, beginning 3 months prior the start trial treatment
  • Patient with isolated cutaneous scleroderma treated with a drug potentially interfering with the course of the disease 4 weeks before starting the trial (Systemic corticosteroids, methotrexate, cyclophosphamide, bosentan)
  • Scleroderma " en coup de sabre "
  • Severe organ failure or anomaly of blood chemistry/hematology (bilirubin, SGOT, SGPT, creatinine > 1,5 ´ upper normal limit, polymorphonuclear granulocytes less than 1*10*9/l or platelets less than 50*10*9/l),
  • Ongoing cancer
  • Ejection fraction ≤ 45 per cent at cardiac ultrasound pre inclusion study
  • myocardial infarction of less than 6 mois at pre inclusion visit
  • Non controlled chronic illness (diabetes, chronic kidney failure, chronic hepatitis, HIV infection),
  • Major surgery less than two weeks before inclusion
  • Pregnancy or lactation
  • Absence of validated contraception in childbearing women.
  • Contraindication to imatinib mesylate treatment as specified in product specifications
  • Non observance anticipated and absence of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00479934

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Service de Dermatologie et services de médecine interne et vasculaire - Hôpital St André - CHU de Bordeaux
Bordeaux, France, 33076
Service de Rhumatologie, Hôpital Pellegrin-Tondu CHU de Bordeaux
Bordeaux, France, 33076
Service de Dermatologie - CHG Libourne
Libourne, France, 33500
Service de dermatologie - CHU de Limoges
Limoges, France, 87042
Service de Médecin interne - Hôpital central
Nancy, France, 54035
Service de Médecine interne - Hôpital Saint Louis
Paris, France, 75475
Service de Dermatologie - CHG Périgueux
Perigueux, France, 24000
Service de Dermatologie - service de médecine interne et vasculaire - hopital haut Lévêque - magellan
Pessac, France, 33604
Service de Rhumatologie - CHU de Strasbourg
Strasbourg, France, 67098
Service de Dermatologie - CHU de Toulouse - Hopital Purpan
Toulouse, France, 31059 Toulouse Cedex
Service de Médecine interne - CHU de Tours
Tours, France, 37044
Néphrologie et Médecine interne - CH de Valenciennes
Valenciennes, France, 59322
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
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Study Director: Alain TAIEB, Pr. University Hospital, Bordeaux, France
Study Chair: Geneviève CHENE, Pr University Hospital, Bordeaux, France
Principal Investigator: Alian TAIEB, Pr. University Hospital, Bordeaux, France
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Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux Identifier: NCT00479934    
Other Study ID Numbers: CHUBX 2006/05
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: March 2011
Keywords provided by University Hospital, Bordeaux:
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action