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

Protocol for Investigator Initiated Study: Glivec (imatinib mesylate) in systemic sclerosis, a pilot study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23406

Enrollment

Registered

2008-12-01

Start date

2008-12-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic sclerosis, Glivec (imatinib mesylate)

Interventions

Glivec (imatinib mesylate) 400 mg daily, orally, during 12 months

Eligibility

Inclusion criteria

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 109/L - platelets > 100 x 109/L. 3. Adequate anticonception in women 4. Written informed consent

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Primary efficacy variable: ·Rodnan skin score	—

Secondary

Measure	Time frame
Secondary efficacy variable: · Disease severity score · Number of digital ulcers · Pulmonary function test (CO-diffusion) · Kidney function as measured by creatinin clearance	—

Contacts

Public ContactP.L.A. Daele, van

Erasmus Medical Center Dept. Internal Medicine D-419

p.l.a.vandaele@erasmusmc.nl+31 (0)10 7035954

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)