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

This study is ongoing, but not recruiting participants.

First Received: January 25, 2008 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00613171

Purpose

This study will investigate the efficacy and safety of STI571 for the treatment of fibrosis in patients with systemic sclerosis. Other purposes of the study are to investigate whether STI571 is effective in improving lung functions and other test results called biomarkers. Whether STI571 is well-absorbed in systemic sclerosis patients' gut will also be investigated by testing the drug level in the blood (pharmacokinetics).

Condition	Intervention	Phase
Systemic Sclerosis, Scleroderma	Drug: STI571	Phase II

MedlinePlus related topics: Scleroderma

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multi-Centre, Open-Label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic Sclerosis

Further study details as provided by Novartis:

Primary Outcome Measures:

Percentage change from baseline in modified Rodnan Skin Score (MRSS) at each time point of analysis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of non-response, partial response, complete response, remission or relapse assessed by MRSS values. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	27
Study Start Date:	January 2008
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: STI571

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients who are equal to or older than 18 years of age and who have early diffuse systemic sclerosis (Disease duration < 18 months from the first non-Raynaud's symptom)
Patients 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
Practicing two acceptable forms of contraception

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613171

Locations

United States, Illinois
Novartis Investigator Site
Chicago, Illinois, United States, 60611
United States, Maryland
Novartis Investigator Site
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Novartis Investigator Site
Boston, Massachusetts, United States, 02118
Germany
Novartis Investigator Site
Erlangen, Germany
Italy
Novartis Investigator Site
Florence, Italy
Switzerland
Novartis Investigator Site
Zurich, Switzerland
United Kingdom
Novartis Investigator Site
London, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

NOVARTIS

Novartis investigator site

More Information

No publications provided

Responsible Party:	Novartis ( External affairs )
Study ID Numbers:	CSTI571E2205
Study First Received:	January 25, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00613171 History of Changes
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Switzerland: Swissmedic; Italy: National Institute of Health

Keywords provided by Novartis:

Systemic sclerosis, scleroderma, fibrosis, STI571, imatinib

Study placed in the following topic categories:

Imatinib
Skin Diseases
Fibrosis
Connective Tissue Diseases
Scleroderma

Scleroderma, Diffuse
Sclerosis
Scleroderma, Systemic
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Fibrosis
Antineoplastic Agents
Sclerosis
Enzyme Inhibitors
Protein Kinase Inhibitors

Pharmacologic Actions
Imatinib
Pathologic Processes
Therapeutic Uses
Connective Tissue Diseases
Scleroderma, Diffuse
Scleroderma, Systemic

ClinicalTrials.gov processed this record on May 07, 2009