Multiple Sclerosis Clinical Trial
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
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).
Eligibility 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
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There are 3 Locations for this study
Chicago Illinois, 60611, United States
Baltimore Maryland, 21224, United States
Boston Massachusetts, 02118, United States
Erlangen , , Germany
Florence , , Italy
Zurich , , Switzerland
London , , United Kingdom
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