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Scleroderma, Systemic clinical trials

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NCT ID: NCT00377949 Completed - Clinical trials for Pulmonary Hypertension

Multi-center, Web Based Observational Study of Pulmonary Hypertension in Scleroderma Patients

Start date: February 2005
Phase: N/A
Study type: Observational

The purpose of this study is to determine the timeline of progression from pre-pulmonary hypertension to diagnosable pulmonary hypertension based on right heart catheterization. Moreover, to determine the timeline for progression from diagnosable pulmonary hypertension to clinical worsening of disease as defined as death, hospitalization, or worsening of PHT symptoms.

NCT ID: NCT00372398 Completed - Scleroderma Clinical Trials

Premature Coronary Atherosclerosis in Scleroderma

Start date: October 2006
Phase: N/A
Study type: Observational

The purpose of this trial is to study the proportion of scleroderma patients who suffer from asymptomatic coronary atherosclerosis compared to healthy controls.

NCT ID: NCT00348296 Completed - Clinical trials for Scleroderma, Systemic

Efficacy and Safety Study of GB-0998 for Treatment of Systemic Sclerosis

Start date: July 2006
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled multi-center study will carry out to assess the efficacy of GB-0998 in the treatment of the systemic sclerosis based on the changes in modified Rodnan total skin thickness score (TSS) as primary endopoint, and in addition, to assess the safety of GB-0998.

NCT ID: NCT00333437 Completed - Clinical trials for Scleroderma, Systemic

Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement

Start date: May 2006
Phase: N/A
Study type: Interventional

Researchers from the Division of Pulmonary and Critical Care Medicine at University of California, San Francisco (UCSF) are conducting a study to evaluate whether mycophenolate mofetil (an immunosuppressive medication, trade named CellCept) is safe and effective for preventing the lung damage from scleroderma from getting worse.

NCT ID: NCT00319033 Completed - Clinical trials for Interstitial Lung Disease

Open-label Study With Bosentan in Interstitial Lung Disease

BUILD 2 OL
Start date: July 2004
Phase: Phase 2/Phase 3
Study type: Interventional

This study will asses the long term safety and efficacy of oral bosentan to patients suffering from Interstitial Lung Disease.

NCT ID: NCT00318188 Completed - Clinical trials for Systemic Scleroderma

Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

SCLEREDUC
Start date: September 2005
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. To date, no pharmacological treatment have been shown to be effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is that rehabilitation could be an interesting non pharmacological treatment in order to decrease the handicap of SSc patients. Our objective is to evaluate the effect of a personalized standardized rehabilitation program on the quality of life of SSc patients in a multicentric randomized controlled trial. This trial will compare a personalized standardized rehabilitation program to the usual non pharmacological treatment. The primary outcome measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design will be used for this study.

NCT ID: NCT00318175 Completed - Clinical trials for Systemic Scleroderma

Effect of Bosentan on Skin Fibrosis in Patients With Systemic Sclerosis

Start date: June 2006
Phase: Phase 2
Study type: Interventional

Endothelin-1 is a potent vasoconstrictor and binds to two receptors, ET-A and ET-B, which are variable expressed on endothelial cells, smooth muscle cells, and fibroblasts. Furthermore, endothelin-1 has been found to be released in vitro by scleroderma fibroblasts and could contribute to the development of dermal fibrosis in systemic sclerosis. Bosentan is a dual receptor antagonist, that competes with the binding of endothelin-1 to both receptors and has already been approved for the treatment of pulmonary arterial hypertension in Europe, the US, and some other countries. The purpose of this study is to evaluate the effect of bosentan treatment on skin fibrosis and functionality in patients with systemic sclerosis.

NCT ID: NCT00278525 Completed - Clinical trials for SYSTEMIC SCLERODERMA

Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma

Start date: September 2005
Phase: Phase 2
Study type: Interventional

Scleroderma is a systemic disorder categorized as an immunologically mediated disease that causes collagen deposition of skin and visceral organs. The molecular pathogenesis of scleroderma has been elusive, although vasculopathy and immune mediated mechanisms are thought to be important. Once extensive cutaneous or visceral disease occurs, prognosis is significantly shorter than the general population. Although various treatments have been tried, none of them seems to have changed the natural history of scleroderma. Standard dose immunosuppressive treatment has been disappointing. Recently, cyclophosphamide at 1-2 mg/kg/day orally or 800-1400 mg intravenous (IV) monthly for 6-9 months has proven effective in treatment of scleroderma alveolitis (1). Recent phase I studies of immunoablation with autologous peripheral blood stem cell transplantation (PBSCT) showed some promising data, but the exact efficacy is undetermined (2,3). We now propose, as a phase II randomized study, autologous unmanipulated PBSCT versus pulse cyclophosphamide in patients with systemic scleroderma.

NCT ID: NCT00241189 Completed - Systemic Sclerosis Clinical Trials

Rapamycin vs Methotrexate in Diffuse SSc

Start date: August 2002
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study to determine the safety of the immunosuppressive rapamycin in patients with systemic sclerosis with diffuse cutaneous scleroderma. The effects (both good and bad) are being compared to another group of systemic sclerosis patients receiving methotrexate

NCT ID: NCT00213525 Completed - Scleroderma Clinical Trials

Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Controls

Start date: October 2004
Phase: N/A
Study type: Observational

Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental factors, and particularly toxic drug exposure, in the genesis of scleroderma has been suggested. This prompted us to conduct this prospective, case-control, multicentric study, including 2 groups of subjects: - 100 patients with scleroderma - 300 sex- and age-matched healthy controls. The aim of our study is to determine whether exposure to toxics is higher in patients with scleroderma compared with healthy controls.