Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Patients With Systemic Sclerosis

Status:	Completed
Conditions:	Neurology, Dermatology, Dermatology
Therapuetic Areas:	Dermatology / Plastic Surgery, Neurology
Healthy:	No
Age Range:	18 - Any
Updated:	10/12/2018
Start Date:	January 2008
End Date:	January 2010

A Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic Sclerosis

This study will investigate the efficacy and safety of STI571 for the treatment of fibrosis
in patients with systemic sclerosis. Other purposes of the study are to investigate whether
STI571 is effective in improving lung functions and other test results called biomarkers.
Whether STI571 is well-absorbed in systemic sclerosis patients' gut will also be investigated
by testing the drug level in the blood (pharmacokinetics).

Inclusion Criteria:

- Male and female patients who are equal to or older than 18 years of age and who have
early diffuse systemic sclerosis (Disease duration < 18 months from the first
non-Raynaud's symptom)

- Patients with a modified Rodnans Skin Score (MRSS) of at least 20 in the absence of
trunk involvement or a MRSS of at least 16 in patients with trunk involvement

- Practicing two acceptable forms of contraception

Exclusion Criteria:

- Concurrent connective tissue diseases other than systemic sclerosis

- Significant pre-existing heart, liver, lungs, digestive system, blood and other
diseases, cancer

- Conditions that might mimic the potential side effects of STI571 (blood conditions,
liver damage, chronic diarrhea, edema)

- Concurrent medical therapies (or during last 6 weeks before first dosing) that may
potentially influence outcome of the study

- allergic to the study medication

- Pregnancy

- Breast feeding

We found this trial at

sites

Novartis Investigator Site

Erlangen,

from

Erlangen,