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Sponsors and Collaborators: |
University of California, Los Angeles Novartis |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00512902 |
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. Inatinib 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.
Condition | Intervention |
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Alveolitis Systemic Sclerosis |
Drug: Gleevec |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Pilot Study to Examine The Use of Imatinib (Gleevec) For The Treatment of Active Alveolitis in Systemic Sclerosis |
Estimated Enrollment: | 20 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tina Burger, Study Coord | 310-825-4744 | cburger@mednet.ucla.edu |
Contact: Amber Bechtel, Study Coord | 310-825-0425 | abechtel@mednet.ucla.edu |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-0358 | |
Contact: James R Seibold, MD 734-763-3110 jseibold@umich.edu | |
Sub-Investigator: James R Seibold, MD | |
United States, Texas | |
The University of Texas | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Maureen Mayes, MD 713-500-6900 Maureen.D.Mayes@uth.tmc.edu | |
Sub-Investigator: Maureen Mayes, MD |
Principal Investigator: | Daniel E. Furst, MD | University of California, Los Angeles |
Responsible Party: | UCLA ( Daniel Furst, M.D. ) |
Study ID Numbers: | CST1571EUS210 |
Study First Received: | August 6, 2007 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00512902 |
Health Authority: | United States: Food and Drug Administration |
active alveolitis in systemic sclerosis |
Imatinib Skin Diseases Connective Tissue Diseases Sclerosis Scleroderma, Systemic |
Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |