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Current Research in Scleroderma in the Form of Clinical Trials May Help with This Disease

written by: cra8051 • edited by: Leigh A. Zaykoski • updated: 3/15/2010

Current research in scleroderma treatment may offer some hope for sufferers from this chronic and often disabling disease. Often the first news of drugs and other treatment methods under study is found through research in clinical trials underway or completed.

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    Background

    Scleroderma, also referred to as Systemic Sclerosis, is a connective tissue disease causing degenerative changes in the skin, joints and internal organs. There is no known cure and the disease may be fatal. Some drugs may help with the symptoms and reduce organ damage. Identified risk factors include Native Americans living in certain areas, for example, Choctaws in Oklahoma contract scleroderma twenty times as often as those living in Mississippi. The disease is more common among African-Americans. Women tend to develop this condition four times or more often than men. Some identified environmental factors are exposure to silica dust, solvents like paint thinners and some chemotherapy drugs. Raynaud’s Phenomenon is one typical manifestation of the condition [1].

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    Clinical Trials

    As of March, 2010, there were 56 open clinical studies recruiting or on the verge of recruiting patients for current research in scleroderma. An additional 65 studies were either active but not recruiting, or completed. Some of the most pertinent are listed below. Each identified study includes the title, sponsor, contact information with telephone if available and the Clinical Trials identifier, which you or your doctor can use to locate more information. Any related publications, if available, are listed in the applicable reference note (the number in brackets at the end of the listing). Information on the remaining trials not covered here is available at ClinicalTrials.gov:scleroderma.

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    Completed Trials

    “Psychological Treatments for Scleroderma,” National Institute of Arthritis and Musculoskeletal and Skin Diseases, Jennifer A. Haythornthwaite, Johns Hopkins University, NCT00007267 [2].

    “Oral Type I Collagen for Relieving Scleroderma,” National Institute of Arthritis and Musculoskeletal and Skin Disease, Arnold E. Postlethwaite, MD, University of Tennessee at Memphis, NCT 00005675 [3].

    “UVA1 Light for Treatment of Scleroderma and Similar Conditions,” Sewon Kang, MD, University of Michigan Hospital,NCT00476801.

    “Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma,” James R. Seibold, MD, University of Medicine and Dentistry New Jersey, NCT00704665.

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    Active Trials not Recruiting

    “A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud’s Phenomenon,” Fredrick M. Wigley, MD, Johns Hopkins University, NCT00498615.

    “Gleevec in the Treatment of Systemic Sclerosis,” Robert Spiera, MD, Hospital for Special Surgery, New York, NCT00555581.

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    Trials Recruiting Volunteers

    .“Placebo Controlled Trial of Bosentan in Scleroderma Patients,” Virginia D. Steen, M.D. 202-687-8233, Georgetown University. NCT00377455.

    “Exercise Induced Pulmonary Hypertension in System Sclerosis and Treatment with Ambrisentan,”Rajeev Saggar, MD, 310-825-5635, University of California, Los Angeles, NCT01051960.

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    Summary

    Current research on scleroderma through clinical trials identified by the National Institutes of Health can provide the earliest possible information on new treatments under study for this debilitating disease. Patients who are considering volunteering for a clinical trial should consult with their doctors about the benefits and risks of participation. Contacting some of the principal investigators identified with completed studies in the Clinical Trials database is another possible source of new information.

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    References

    [1]. Mayo Clinic: Scleroderma

    [2]. Haythornthwaite JA, et al., “Psychologic factors in scleroderma,” Rheumatic Diseases Clinics of North America. 2003 May;29(2):427-39.

    [3]. Postlethwaite AE, et al., “A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis,” Arthritis and Rheumatism. 2008 Jun; 58(6):1810-22.

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    Disclaimer

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