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.
ID
Bron
Verkorte titel
Aandoening
Systemic sclerosis, Glivec (imatinib mesylate)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary efficacy variable:<br>
· Rodnan skin score
Achtergrond van het onderzoek
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
Doel van het onderzoek
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.
Onderzoeksopzet
December 2008 - recruitment
First patient in: December 2008
Last patient out: April 2010
Onderzoeksproduct en/of interventie
Glivec (imatinib mesylate) 400 mg daily, orally, during 12 months
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1495 |
| NTR-old | NTR1565 |
| Ander register | Novartis : CSTI571ENL18 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |