Conditions: Systemic Sclerosis, Scleroderma
Keywords: Systemic sclerosis, scleroderma, fibrosis, STI571, imatinib
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 27
Healthy volunteers: no

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 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).

Detailed description:

Arms:
arm 1: Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.

Interventions: intervention 1: STI571
Intervention descriptions: intervention 1: STI571 tablets taken orally once a day

Protocol document: