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| Sponsor: | University of California, Los Angeles |
|---|---|
| Collaborator: |
Novartis Pharmaceuticals |
| Information provided by (Responsible Party): | Daniel Furst, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00512902 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Alveolitis Systemic Sclerosis |
Drug: Gleevec |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2007 |
| Study Completion Date: | December 2008 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| The University of Texas | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Daniel E. Furst, MD | University of California, Los Angeles |
More Information
| Responsible Party: | Daniel Furst, M.D., Carl M Pearson Professor of Rheumatology, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00512902 History of Changes |
| Other Study ID Numbers: | CST1571EUS210 |
| Study First Received: | August 6, 2007 |
| Last Updated: | August 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
active alveolitis in systemic sclerosis |
|
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Connective Tissue Diseases Skin Diseases Pathologic Processes Imatinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |