systemic sclerosis MedDRA version: 9.1 Level: LLT Classification code 10039710 Term: Scleroderma
Conditions
Interventions
Product Name: Glivec
Pharmaceutical Form: Capsule*
Sponsors
ErasmusMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Patients with systemic sclerosis (either diffuse or limited) refractory to standard therapy · Adequate end organ function, defined as: total bilirubin 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
Exclusion criteria
Exclusion criteria: · 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed