Status:
COMPLETED
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Systemic Sclerosis, Scleroderma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 effec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00613171
Start Date
January 2 2008
End Date
January 13 2010
Last Update
July 7 2021
Active Locations (7)
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1
Novartis Investigator Site
Chicago, Illinois, United States, 60611
2
Novartis Investigator Site
Baltimore, Maryland, United States, 21224
3
Novartis Investigator Site
Boston, Massachusetts, United States, 02118
4
Novartis Investigator Site
Erlangen, Germany