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

Novartis

Status and phase: Completed; Phase 2

Conditions: Systemic Sclerosis, Scleroderma

Treatments: Drug: STI571

Study type: Interventional

Funder types: Industry

Identifiers

NCT00613171

CSTI571E2205

Details and patient eligibility

About

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).

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

ST1571

Experimental group

Description:

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.

Treatment:

Drug: STI571