Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis
- Conditions
- systemic sclerosisMedDRA version: 9.1Level: LLTClassification code 10039710Term: Scleroderma
- Registration Number
- EUCTR2006-007091-15-NL
- Lead Sponsor
- ErasmusMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10
·Patients with systemic sclerosis (either diffuse or limited) refractory to standard therapy
·Adequate end organ function, defined as: total bilirubin <1.5 x ULN, SGOT and SGPT < 2.5 x ULN (or <5 x ULN if hepatic disease involvement is present), creatinine < 1.5 x ULN, ANC >1.5 x 109/L, platelets > 100 x 109/L.
·Adequate anticonception in women
·Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
·Age < 18 years
·Previous or current malignancy
·Current treatment with endothelin receptor antagonist
·Current treatment with immunosuppressive drugs
·Life expectancy < 6 months
·Pregnancy
·Inability to adhere to the current protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy (and the toxicity) of Glivec in systemic sclerosis by examining clinical outcomes (clinical and laboratory findings).;Secondary Objective: ;Primary end point(s): Rodnan skin score
- Secondary Outcome Measures
Name Time Method