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

Phase 2

• Conditions: sclerodermia; systemic sclerosis; 10021460

• Registration Number: NL-OMON30793
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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 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.
· Adequate anticonception in women
· Written informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rodnan skin score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>· Disease severity score<br /><br>· Number of digital ulcers<br /><br>· Pulmonary function test (CO-diffusion)<br /><br>· Kidney function as measured by creatinin clearance</p><br>