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Efficacy and Safety of Imatinib in Scleroderma (SCLEROGLIVEC)

Primary Purpose

Scleroderma, Localized, Scleroderma, Systemic

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
imatinib mesylate
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Localized focused on measuring scleroderma, imatinib, PDGFR, Rodnan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Dermatologie et services de médecine interne et vasculaire - Hôpital St André - CHU de Bordeaux
  • Service de Rhumatologie, Hôpital Pellegrin-Tondu CHU de Bordeaux
  • Service de Dermatologie - CHG Libourne
  • Service de dermatologie - CHU de Limoges
  • Service de Médecin interne - Hôpital central
  • Service de Médecine interne - Hôpital Saint Louis
  • Service de Dermatologie - CHG Périgueux
  • Service de Dermatologie - service de médecine interne et vasculaire - hopital haut Lévêque - av.de magellan
  • Service de Rhumatologie - CHU de Strasbourg
  • Service de Dermatologie - CHU de Toulouse - Hopital Purpan
  • Service de Médecine interne - CHU de Tours
  • Néphrologie et Médecine interne - CH de Valenciennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

6 month treatment with Imtinib 400mg/day

6 month treatment with Placebo 400mg/day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Assess skin thickness at inclusion and at 6 months using skin biopsies
Assessment of quality of life using DLQI (Dermatology Quality of Life Index) and HAQ (Health Assessment Questionnaire).
Assess tolerance of treatment (clinical and laboratory monitoring of side effects)
Assess effects of treatment on non cutaneous symptoms in systemic sclerosis patients

Full Information

First Posted
May 29, 2007
Last Updated
March 3, 2011
Sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00479934
Brief Title
Efficacy and Safety of Imatinib in Scleroderma
Acronym
SCLEROGLIVEC
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Ministry of Health, France, Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Localized, Scleroderma, Systemic
Keywords
scleroderma, imatinib, PDGFR, Rodnan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
6 month treatment with Imtinib 400mg/day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
6 month treatment with Placebo 400mg/day
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Intervention Description
6 month treatment with 400mg/day (per os)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Assess skin thickness at inclusion and at 6 months using skin biopsies
Time Frame
6 month
Title
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,
Title
Assess tolerance of treatment (clinical and laboratory monitoring of side effects)
Time Frame
All along the trial
Title
Assess effects of treatment on non cutaneous symptoms in systemic sclerosis patients
Time Frame
All along the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain TAIEB, Pr.
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Geneviève CHENE, Pr
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alian TAIEB, Pr.
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Dermatologie et services de médecine interne et vasculaire - Hôpital St André - CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service de Rhumatologie, Hôpital Pellegrin-Tondu CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service de Dermatologie - CHG Libourne
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Service de dermatologie - CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Service de Médecin interne - Hôpital central
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Service de Médecine interne - Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Service de Dermatologie - CHG Périgueux
City
Perigueux
ZIP/Postal Code
24000
Country
France
Facility Name
Service de Dermatologie - service de médecine interne et vasculaire - hopital haut Lévêque - av.de magellan
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Service de Rhumatologie - CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Service de Dermatologie - CHU de Toulouse - Hopital Purpan
City
Toulouse
ZIP/Postal Code
31059 Toulouse Cedex
Country
France
Facility Name
Service de Médecine interne - CHU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Néphrologie et Médecine interne - CH de Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France

12. IPD Sharing Statement

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Efficacy and Safety of Imatinib in Scleroderma

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