Overview

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

Status:
Completed

Trial end date:
2010-01-13

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Imatinib Mesylate

Criteria

Inclusion Criteria:

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

- Participants 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

- Female patients of childbearing potential practicing two acceptable forms of
contraception

Exclusion Criteria:

- SSc patients with a MRSS greater than 35

- 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