A Study Using The Experimental Drug Called Imatinib (Gleevec) in Subjects With Systemic Sclerosis
The purpose of this study is to assess the safety and tolerability of imatinib (gleevec) in subjects who have systemic sclerosis. Imatinib has been approved by the FDA for the treatment of newly diagnosed adult patients with CML (newly diagnosed adult patients and for the treatment of patients with an accelerated phase. Imatinib is also approved for the treatment of patients with a certain type of gastrointestinal cancer (called stromal tumors) but it has not been approved to treat systemic sclerosis. Imatinib works by interfering with an enzyme called tyrosine phosphatase resulting in suppression of the immune system. It als interferes with a protein called platelet derived growth factor receptor (PDGFr) that has been linked to increased fibrosis.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic Sclerosis|
- Treatment-related Adverse Events [ Time Frame: Baseline vs. Endpoint (1 year) ] [ Designated as safety issue: Yes ]Treatment-related adverse events requiring discontinuation.
- Change in FVC (Forced Vital Capacity) [ Time Frame: Baseline vs. Endpoint (1 year) ] [ Designated as safety issue: No ]Measures the amount of air breathed out as a percent of predicted.
- Change in TLC (Total Lung Capacity) [ Time Frame: Baseline vs. Endpoint (1 year) ] [ Designated as safety issue: No ]No measures of dispersion was available for TLC as data were lost. This describes the total lung capacity as a percent of predicted.
- Change in DLco [ Time Frame: Baseline vs. Endpoint (1 year) ] [ Designated as safety issue: No ]DLCO (diffusing capacity or transfer factor of the lung for carbon monoxide (CO)) is the extent to which oxygen passes from the air sacs of the lungs into the blood. Commonly, it refers to the test used to determine this parameter.
- Change in Modified Rodnan Skin Score (MRSS) [ Time Frame: Baseline vs. Endpoint ] [ Designated as safety issue: No ]No measures of dispersion was available as data were lost. The range of this measure is 0 to 51 and measures the extent of skin thickening with higher numbers representing thickening.
|Study Start Date:||August 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Experimental: Group 1
SSc patients receiving Imatinib (Gleevec, up to 600 mg) QD PO for up to 1 year.
All subjects will receive gleevec. Subjects will have a clinic visit every 2 weeks for the first 20 weeks and then they will have one every 4 weeks for the remainder of the study. Gleevec will be taken by mouth everyday. It will be increased to a maximum of 600 mg every day. It will be increased 100 mg at each visit for the first 12 weeks. Your participation may last up to 1 year and participants will have approximately 18 clinic visits.
Other Name: GleevecDrug: Imatinib
Up to 600 mg QD PO for up to 1 year.
Other Name: Gleevec
Systemic sclerosis is a rare, progressive disease that leads to hardening and tightening of the skin and connective tissues. It usually begins with a few dry patches of skin on the hands or face that begin getting thicker and harder. These patches then spread to other areas of the skin. In some cases, systemic sclerosis also affects the blood vessels an internal organs. Systemic sclerosis is one of a group of arthritic conditions called connective tissue disorders, a person's antibodies are directed against their own tissues.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512902
|United States, California|
|UCLA David Geffen School of Medicine, Division of Rheumatology|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Daniel E. Furst, MD||University of California, Los Angeles|