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Scleroderma, Diffuse clinical trials

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NCT ID: NCT00479934 Completed - Clinical trials for Scleroderma, Systemic

Efficacy and Safety of Imatinib in Scleroderma

SCLEROGLIVEC
Start date: December 2007
Phase: Phase 2
Study type: Interventional

In vitro studies have shown that imatinib 1mM inhibits strongly the growth of cutaneous fibroblasts. The hypothesis is that imatinib inhibits PDGFR which is known to be a potential target for the molecule, as recently also proposed after the discovery of autoantibodies activating the PDGF receptors. Recent data indicate that TGFb is also a potential target of imatinib. Cutaneous scleroderma is characterized by progressive cutaneous fibrosis caused by hyperactive dermal fibroblasts. Since no established treatment for skin sclerosis in scleroderma is currently available. This study will test the safety and efficacy of imatinib in the treatment of patients with scleroderma and severe cutaneous involvement.

NCT ID: NCT00476801 Completed - Scleroderma Clinical Trials

UVA1 Light for Treatment of Scleroderma and Similar Conditions

Start date: July 2001
Phase: N/A
Study type: Interventional

The purpose of this investigation is to evaluate the effectiveness of an investigational device which is similar in appearance to a "tanning bed" but which emits ultraviolet irradiation of a specific wavelength known as UVA1. This device has not been approved by the FDA for general use in this country, as yet, but it has been used quite successfully in Europe for several years in treating such conditions as scleroderma, keloids, and other fibrosing conditions of the skin. Your participation in this study may yield important information regarding the safety and effectiveness of this form of light therapy for the treatment of these skin conditions which, at present, are difficult to treat.

NCT ID: NCT00442611 Completed - Clinical trials for Scleroderma, Systemic

A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options. We hypothesize that treatment with abatacept, a new therapy recently approved for the treatment of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people with scleroderma.

NCT ID: NCT00433186 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Mycophenolate Mofetil in Systemic Sclerosis

Start date: March 2006
Phase: Phase 1
Study type: Interventional

This is a research study of an investigational product called Mycophenolate mofetil (MMF). The study is designed to establish the safety and potential benefit of MMF. MMF has proven one of the most effective medications to date for SLE and associated nephritis. It also appears to be active in polymyositis and dermatomyositis. This medication inhibits inosine monophosphate dehydrogenase, the rate-limiting enzyme in synthesis of guanosine nucleotides. It blocks the type II isoform found in activated lymphocytes more potently than the type I isoform inhibiting both T- and B-lymphocytes. In SSc, MMF has been tried after anti-thymocyte globulin in one small open label study with efficacy with a significant improvement in skin score. We will test the safety and efficacy of MMF in SSc. All study patients will receive the study medication. The effect of the study medication will be examined in two subgroups of patients: those with early or progressive skin disease (skin substudy) and those with muscle disease (muscle substudy). The change in modified Rodnan skin score (MRSS) and creatinine phosphokinase (CK) for, respectively, the skin and muscle substudies at 6 months after treatment will be compared to baseline values.

NCT ID: NCT00379431 Completed - Clinical trials for Early and Severe Systemic Sclerosis

A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab

Start date: November 27, 2006
Phase: Phase 2
Study type: Interventional

Rituximab 1000 mg i.v. will be given on day 1 and 15, week 26 - 28, together with a corticosteroid regimen consisting of methylprednisolone 100 mg i.v. 30 minutes prior to both infusions.

NCT ID: NCT00378521 Completed - Raynaud's Disease Clinical Trials

Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon

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

The Purpose of this study is to determine the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.

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.