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Scleroderma, LocalizedPhase 2SCLEROGLIVECNCT00479934

Efficacy and Safety of Imatinib in Scleroderma

A Phase 2 study testing imatinib mesylate in people with Scleroderma, Localized and Scleroderma, Systemic, run by University Hospital, Bordeaux at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scleroderma, Localized, Scleroderma, Systemic
What is being tested?
imatinib mesylate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
12 sitesFrance
Study dates
Dec 2007to Dec 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Service de Dermatologie et services de médecine interne et vasculaire - Hôpital St André - CHU de Bordeaux

    Bordeaux, 33076

  • Service de Rhumatologie, Hôpital Pellegrin-Tondu CHU de Bordeaux

    Bordeaux, 33076

  • Service de Dermatologie - CHG Libourne

    Libourne, 33500

  • Service de dermatologie - CHU de Limoges

    Limoges, 87042

  • Service de Médecin interne - Hôpital central

    Nancy, 54035

  • Service de Médecine interne - Hôpital Saint Louis

    Paris, 75475

  • Service de Dermatologie - CHG Périgueux

    Périgueux, 24000

  • Service de Dermatologie - service de médecine interne et vasculaire - hopital haut Lévêque - av.de magellan

    Pessac, 33604

  • Service de Rhumatologie - CHU de Strasbourg

    Strasbourg, 67098

  • Service de Dermatologie - CHU de Toulouse - Hopital Purpan

    Toulouse, 31059 Toulouse Cedex

  • Service de Médecine interne - CHU de Tours

    Tours, 37044

  • Néphrologie et Médecine interne - CH de Valenciennes

    Valenciennes, 59322

Other trials in France

About this 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.

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.

Read the 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.

Being tested
imatinib mesylate
Keywords
scleroderma, imatinib, PDGFR, Rodnan
Medical subject headings
Scleroderma, Localized, Scleroderma, Systemic, Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • imatinib mesylateDrug

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

Study groups in NCT00479934
Study groupRoleWhat they receive
1Experimental6 month treatment with Imtinib 400mg/day
Receives: Drug: imatinib mesylate
2Placebo comparator6 month treatment with Placebo 400mg/day
Receives: Drug: imatinib mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 month

Secondary outcomes (5)

  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.

    Measured: 1, 3 and 12 month

  2. Assess skin thickness at inclusion and at 6 months using skin biopsies

    Measured: 6 month

  3. Assessment of quality of life using DLQI (Dermatology Quality of Life Index) and HAQ (Health Assessment Questionnaire).

    Measured: At 1, 3, 6 month and 1 year,

  4. Assess tolerance of treatment (clinical and laboratory monitoring of side effects)

    Measured: All along the trial

  5. Assess effects of treatment on non cutaneous symptoms in systemic sclerosis patients

    Measured: All along the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2010
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00479934
Sponsor's protocol ID
CHUBX 2006/05
Other IDs
2006/017
Acronym
SCLEROGLIVEC
Status last verified
Mar 2011
First submitted
29 May 2007
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Prey S, Ezzedine K, Doussau A, Grandoulier AS, Barcat D, Chatelus E, Diot E, Durant C, Hachulla E, de Korwin-Krokowski JD, Kostrzewa E, Quemeneur T, Paul C, Schaeverbeke T, Seneschal J, Solanilla A, Sparsa A, Bouchet S, Lepreux S, Mahon FX, Chene G, Taieb A. Imatinib mesylate in scleroderma-associated diffuse skin fibrosis: a phase II multicentre randomized double-blinded controlled trial. Br J Dermatol. 2012 Nov;167(5):1138-44. doi: 10.1111/j.1365-2133.2012.11186.x. Epub 2012 Oct 5.

    PubMed 23039171

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib mesylate in people with Scleroderma, Localized and Scleroderma, Systemic, run by University Hospital, Bordeaux at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00479934, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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