Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00479934
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00479934
Study Brief:
Protocol Section:
NCT00479934