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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-02

Study Completion Date

2010-01-13

Brief Summary

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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).

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Detailed Description

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Conditions

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Systemic Sclerosis, Scleroderma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ST1571

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.

Group Type EXPERIMENTAL

STI571

Intervention Type DRUG

STI571 tablets taken orally once a day

Interventions

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STI571

STI571 tablets taken orally once a day

Intervention Type DRUG

Other Intervention Names

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Gleevec, Glivec

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No