No registrations found.
ID
Source
Brief title
Health condition
Systemic sclerosis, Glivec (imatinib mesylate)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy variable:
· Rodnan skin score
Secondary outcome
Secondary efficacy variable:
· Disease severity score
· Number of digital ulcers
· Pulmonary function test (CO-diffusion)
· Kidney function as measured by creatinin clearance
Background summary
Design: an open label, investigator initiated study
Subjects: patients with systemic sclerosis (either diffuse or limited) refractory to standard therapy
Study medication: Glivec (imatinib mesylate) 400 mg daily, orally, during 12 months
Clinical Phase: Phase II (pilot study)
Objectives:
To investigate the efficacy (and the toxicity) of Glivec in systemic sclerosis by examining clinical outcomes (clinical and laboratory findings).
Primary efficacy variable:
· Rodnan skin score
Secondary efficacy variables:
· Disease severity score
· Number of digital ulcers
· Pulmonary function test (CO-diffusion)
· Kidney function as measured by creatinin clearance
Study objective
It is assumed that treatment with Imatinib mesylate will inhibit fibroblast proliferation in systemic sclerosis thereby leading to an improvement in clinical condition in patients.
Study design
December 2008 - recruitment
First patient in: December 2008
Last patient out: April 2010
Intervention
Glivec (imatinib mesylate) 400 mg daily, orally, during 12 months
Dept. Internal Medicine<br>
D-419
P.L.A. Daele, van
's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7035954
p.l.a.vandaele@erasmusmc.nl
Dept. Internal Medicine<br>
D-419
P.L.A. Daele, van
's Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7035954
p.l.a.vandaele@erasmusmc.nl
Inclusion criteria
1. Patients with systemic sclerosis (either diffuse or limited) refractory to standard therapy
2. 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.
3. Adequate anticonception in women
4. Written informed consent
Exclusion criteria
1. Age < 18 years
2. Previous or current malignancy
3. Current treatment with endothelin receptor antagonist
4. Current treatment with immunosup-pressive drugs
5. Life expectancy < 6 months
6. Pregnancy
7. Inability to adhere to the current protocol
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1495 |
| NTR-old | NTR1565 |
| Other | Novartis : CSTI571ENL18 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |