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Scleroderma, Systemic clinical trials

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NCT ID: NCT00853788 Completed - Systemic Sclerosis Clinical Trials

Skin Biopsy Specimens as Biomarkers of Systemic Sclerosis and Response to Mycophenolate Mofetil

Start date: November 2008
Phase: N/A
Study type: Observational

The purpose of this study is to assess whether skin biopsy specimens from patients with diffuse cutaneous systemic sclerosis (dcSSc) can be used as biomarkers (measures of activity and type) of disease to predict response to various experimental treatments. There are various experimental treatments being used in the treatment of slceroderma, but there is no way to predict response to any given therapy. The investigators will use DNA microarray to analyze the changes in gene expression in skin biopsies in response to various treatments. Our hypothesis is that the investigators will see changes in gene expression in response to various treatments that will give us insight into the cause of scleroderma. The investigators predict that they will be able to use this information to predict which experimental treatments will be beneficial to individual patients

NCT ID: NCT00849745 Terminated - Clinical trials for Systemic Lupus Erythematosus

Nonmyeloablative Allo Stem Cell Transplant for Severe Autoimmune Diseases

Start date: January 2003
Phase: Phase 1
Study type: Interventional

Autoimmune diseases present a special challenge to clinicians and the aim of this protocol is to serve as a last-line effort for patients with unmanageable disease. The primary purpose of this study is to assess feasibility in terms of toxicity and engraftment of a less toxic, nonablative conditioning regimen of Campath-1H, moderate dose fludarabine, and cyclophosphamide for patients with severe autoimmune diseases.

NCT ID: NCT00848939 Completed - Systemic Sclerosis Clinical Trials

Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis

DISTOL-PK
Start date: December 2008
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of treprostinil diethanolamine SR up to a target dose of 4 mg BID.

NCT ID: NCT00848107 Terminated - Systemic Sclerosis Clinical Trials

Open-Label Study of Oral Treprostinil in Digital Ulcers

DISTOL-EXT
Start date: September 2009
Phase: Phase 2
Study type: Interventional

This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.

NCT ID: NCT00843102 Completed - Systemic Sclerosis Clinical Trials

Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis

Start date: December 2007
Phase: N/A
Study type: Observational

Aim: Determination of frequency and nature of coronary involvement (including epicardial and microvascular) among scleroderma patients referred for right heart catheterization.

NCT ID: NCT00775463 Completed - Systemic Sclerosis Clinical Trials

Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

DISTOL-1
Start date: May 2009
Phase: Phase 2
Study type: Interventional

This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally occuring substance produced by the cells of blood vessels that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation. Improvement in blood flow in lower limbs and fingers would be anticipated to result in a reduction in ischemic pain, Raynaud's phenomenon and promote healing of digital ulcers and other ischemic wounds.

NCT ID: NCT00769028 Active, not recruiting - Systemic Sclerosis Clinical Trials

AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis

Start date: December 2008
Phase: Phase 2
Study type: Interventional

To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation. The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score.

NCT ID: NCT00764309 Completed - Scleroderma Clinical Trials

Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis

Start date: January 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.

NCT ID: NCT00740285 Completed - Scleroderma Clinical Trials

Effectiveness and Safety of Lidocaine for Scleroderma

Start date: April 2004
Phase: Phase 2/Phase 3
Study type: Interventional

Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The disease is characterized by thickening and fibrosis skin, affecting vessels and many organs such as the esophagus, stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still unknown, but scientists and medical investigators in a wide variety of fields are working hard to make those determinations. It is known that scleroderma involves overproduction of collagen. FLICKMAN et al, in 1973 published an article about the role of lidocaine at prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production. Until now, there is only a case series showing the improvement of thickening skin (75%) and esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a RCT to prove these findings.

NCT ID: NCT00725361 Completed - Clinical trials for Scleroderma, Systemic

A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).

Start date: June 2008
Phase: N/A
Study type: Interventional

This is a research study of an investigational drug called ambrisentan (Letairis) in the treatment and prevention of digital ulcers in patients with systemic sclerosis.