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Glivec (imatinib mesylate) in systemic sclerosis, a pilot study.


- candidate number4629
- NTR NumberNTR1565
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2008
- Secondary IDsCSTI571ENL18 Novartis
- Public TitleGlivec (imatinib mesylate) in systemic sclerosis, a pilot study.
- Scientific TitleProtocol for Investigator Initiated Study: Glivec (imatinib mesylate) in systemic sclerosis, a pilot study.
- ACRONYMN/A
- hypothesisIt is assumed that treatment with Imatinib mesylate will inhibit fibroblast proliferation in systemic sclerosis thereby leading to an improvement in clinical condition in patients.
- Healt Condition(s) or Problem(s) studiedSystemic sclerosis, Glivec (imatinib mesylate)
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 8-dec-2008
- planned closingdate1-jun-2010
- Target number of participants10
- InterventionsGlivec (imatinib mesylate) 400 mg daily, orally, during 12 months
- Primary outcomePrimary efficacy variable:
Rodnan skin score
- Secondary outcomeSecondary efficacy variable:
Disease severity score
Number of digital ulcers
Pulmonary function test (CO-diffusion)
Kidney function as measured by creatinin clearance
- TimepointsDecember 2008 - recruitment
First patient in: December 2008
Last patient out: April 2010
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. P.L.A. Daele, van
- CONTACT for SCIENTIFIC QUERIESMD. PhD. P.L.A. Daele, van
- Sponsor/Initiator Erasmus Medical Center, Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Novartis
- PublicationsN/A
- Brief summaryDesign: 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
- Main changes (audit trail)
- RECORD1-dec-2008 - 10-dec-2008


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