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Sponsors and Collaborators: |
University Hospital, Bordeaux Ministry of Health, France Novartis |
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Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00479934 |
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 | Intervention | Phase |
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Scleroderma, Localized Scleroderma, Systemic |
Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 34 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
6 month treatment with Imtinib 400mg/day
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Drug: imatinib mesylate
6 month treatment with 400mg/day (per os)
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2: Placebo Comparator
6 month treatment with Placebo 400mg/day
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Drug: imatinib mesylate
6 month treatment with 400mg/day (per os)
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alain Taieb, MD | 33(0) 5 56 79 47 05 | alain.taieb@chu-bordeaux.fr |
France | |
Service de Dermatologie - service de médecine interne et vasculaire - hopital haut Lévêque - av.de magellan | Not yet recruiting |
PESSAC, France, 33604 | |
Contact: Marie-Sylvie DOUTRE, Pr. 33(0) 5 56 55 64 32 marie-sylvie.doutre@chu-bordeaux.fr | |
Principal Investigator: Marie-Sylvie DOUTRE, Pr. | |
Service de dermatologie - CHU de Limoges | Recruiting |
LIMOGES, France, 87042 | |
Contact: Christophe BEDANE, Pr. 33 (0) 5 55 05 64 31 christophe.bedane@chu-limoges.fr | |
Principal Investigator: Chritpophe BEDANE, Pr | |
Service de Dermatologie - CHU de Toulouse - Hopital Purpan | Recruiting |
TOULOUSE, France, 31059 Toulouse Cedex | |
Contact: Carle PAUL, Pr. 33 (0) 5 61 77 76 75 paulc@chu-toulouse.fr | |
Principal Investigator: Carle PAUL, Pr. | |
Service de Dermatologie - CHG Libourne | Recruiting |
LIBOURNE, France, 33500 | |
Contact: Marie-laure BOUYSSON-GAUTHIER, Dr. 33 (0) 5 57 55 26 05 marie-laure.bouyssou-gauthier@ch-libourne.fr | |
Principal Investigator: Marie-laure BOUYSSOU-GAUTHIER, Dr | |
Service de Dermatologie et services de médecine interne et vasculaire - Hôpital St André - CHU de Bordeaux | Recruiting |
BORDEAUX, France, 33076 | |
Contact: Alain TAEIB, Pr. 33(0) 5 56 79 47 05 charlotte.durand-teyssier@chu-bordeaux.fr | |
Contact: Joel CONSTANS, Pr. 33 (0) 5 56 79 47 06 charlotte.durand-teyssier@chu-bordeaux.fr | |
Principal Investigator: Alain TAEIB, Pr. | |
Sub-Investigator: Joel CONSTANS, Pr. | |
Service de Rhumatologie, Hôpital Pellegrin-Tondu CHU de Bordeaux | Recruiting |
BORDEAUX, France, 33076 | |
Contact: Thierry SCHAEVERBEKE, Pr. 33 (0) 5 56 79 55 56 thierry.schaeverbeke@chu-bordeaux.fr | |
Principal Investigator: Thierry SCHAEVERBEKE, Pr. | |
Service de Médecine interne - Hôpital Saint Louis | Recruiting |
PARIS, France, 75475 | |
Contact: Dominique FARGE-BANCEL, Pr (33)-01 42 49 97 68 dominique.farge-bancel@sls.aphp.fr | |
Principal Investigator: Dominique FARGE-BANCEL, Pr | |
Service de Rhumatologie - CHU de Strasbourg | Recruiting |
STRASBOURG, France, 67098 | |
Contact: Jean SIBILIA, Pr (33)-03 88 12 79 54 jean.sibilia@chru-strasbourg.fr | |
Principal Investigator: Jean SIBILIA, Pr | |
Néphrologie et Médecine interne - CH de Valenciennes | Recruiting |
VALENCIENNES, France, 59322 | |
Contact: Thomas QUEMENEUR, Dr (33)-03 27 14 30 89 quemeneur-t@ch-valenciennes.fr | |
Principal Investigator: Thomas QUEMENEUR, Dr | |
Service de Médecine interne - CHU de Tours | Recruiting |
TOURS, France, 37044 | |
Contact: Elisabenth DIOT, Dr (33)-02 47 47 98 19 ediot@med.univ-tours.fr | |
Principal Investigator: Elisabenth DIOT, Dr | |
Service de Médecin interne - Hôpital central | Recruiting |
NANCY, France, 54035 | |
Contact: Jean-Dominique De Korwin, Pr (33)-03 83 85 23 49 jd.dekorwin@chu-nancy.fr | |
Principal Investigator: Jean-Dominique De Korwin, Pr | |
Service de Dermatologie - CHG Périgueux | Not yet recruiting |
PERIGUEUX, France, 24000 | |
Contact: Jean-Pierre MERAUD, Dr. 33 (0) 5 53 45 26 43 jp.meraud@ch-perigueux.fr | |
Principal Investigator: Jean-Pierre MERAUD, Dr. |
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 |
Responsible Party: | University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director ) |
Study ID Numbers: | CHUBX 2006/05, 2006/017 |
Study First Received: | May 29, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00479934 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
scleroderma imatinib PDGFR Rodnan |
Imatinib Skin Diseases Connective Tissue Diseases Scleroderma Scleroderma, Diffuse |
Sclerosis Scleroderma, Systemic Protein Kinase Inhibitors Scleroderma, Localized |
Imatinib Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses Connective Tissue Diseases |
Enzyme Inhibitors Scleroderma, Systemic Protein Kinase Inhibitors Scleroderma, Localized Pharmacologic Actions |