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Scleroderma, Systemic clinical trials

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NCT ID: NCT00707187 Completed - Systemic Sclerosis Clinical Trials

Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction

Start date: July 2001
Phase: Phase 2
Study type: Interventional

Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma

NCT ID: NCT00706082 Terminated - Clinical trials for Pulmonary Hypertension

Early, Simple and Reliable Detection of Pulmonary Arterial Hypertension (PAH) in Systemic Sclerosis (SSc)

DETECT
Start date: October 2008
Phase: N/A
Study type: Observational

A two-stage prospective observational cohort study in scleroderma patients to evaluate screening tests and the incidence of pulmonary arterial hypertension and pulmonary hypertension

NCT ID: NCT00704665 Completed - Systemic Sclerosis Clinical Trials

Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Start date: December 1998
Phase: Phase 3
Study type: Interventional

Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.

NCT ID: NCT00697736 Completed - Clinical trials for Systemic Scleroderma

Cardiac Repercussion of Systemic Sclerodermias

HTAP-SCLERO
Start date: March 2007
Phase: N/A
Study type: Interventional

Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT). In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the other hand, the tracking and the analysis of its effects on the right ventricular function are difficult with the conventional techniques. So, the analysis of the right ventricular function appears capital, because: - it is recognized like an essential determinant of the symptoms and effort capacity, - its prevalence, physiopathology and prognostic values remain unknown in this pathology, - its interest in the starting of the treatment remains to be specified. The aim of this trial is to identify in a population of 150 patients presenting a systemic scleroderma without PAHT: - the incidence of a right ventricular dysfonction, evaluated by the analysis of the myocardic regional function with myocardial tissular Doppler mode, - the physiopathology of this damage by correlation with the tests of respiratory function and the not invasive hemodynamic datas at rest and exercise. - the prognosis value of the abnormalities of the right ventricular function by a follow-up of these patients over a 5 years period. This trial should allowed to define the place of the new right ventricular function markers in the evaluation of the functional consequences, the forecast and perhaps the care of systemic sclerodermic patients.

NCT ID: NCT00684255 Terminated - Clinical trials for Systemic Lupus Erythematosus

Reduced Intensity Transplant in Medically Refractory Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc)

Start date: August 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.

NCT ID: NCT00668473 Completed - Systemic Sclerosis Clinical Trials

Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

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

We propose to examine several angiogenic/angiostatic mediators in the skin and serum of subjects with SSc and compare it to levels found in the skin and serum of healthy subjects.

NCT ID: NCT00667134 Completed - Systemic Sclerosis Clinical Trials

Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis

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

This study is to determine if subjects with .systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening

NCT ID: NCT00628797 Terminated - Systemic Sclerosis Clinical Trials

Effectiveness of UVA1-irradiation in the Treatment of Early Skin Fibrosis in Patients Suffering From Systemic Sclerosis

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

Systemic scleroderma (SSc) is a rare chronic inflammatory diseae of the connective tissue involving the skin and internal organs. To date there is no proven therapy for the skin fibrosis available. A number of case reports and small uncontrolled cohort studies suggest that UVA1 therapy may improve skin fibrosis. The aim of this study is therefore to investigate whether treatment UVA1 in deed is effective in treating skin fibrosis in SSc using a randomized, intraindividual half body irradiation protocol.

NCT ID: NCT00626665 Completed - Raynaud Disease Clinical Trials

Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

Start date: December 2007
Phase: Phase 3
Study type: Interventional

In this double-blinded, placebo-controlled, fixed-dose, study patients will be randomly assigned to take placebo or 20 mg tadalafil thrice weekly for 6 weeks. After 6 weeks a wash out period of 2 week will be observed and then the two groups will be switched over to receive the other drug. We planned a priori to include 20 patients. The concomitant medication for treatment of rheumatic disease remained unchanged during the whole study. Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO heart will be done at base line to assess the PAH and LV function and repeated at the end of the study. Blood pressure will be recorded at each visit. A physician unaware of the treatment group will record skin score and appearance of new cutaneous ulcers. The primary outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated dilatation of the brachial artery will be done at baseline 6 and 12 weeks.

NCT ID: NCT00624273 Completed - Clinical trials for Active Digital Ulcers

Sildenafil for Treatment of Digital Ulcers in Patients With Systemic Sclerosis

Sildenafil
Start date: February 2004
Phase: Phase 2
Study type: Interventional

This is a pilot study analyzing the effect of sildenafil therapy on digital ulcers in systemic sclerosis. We want to analyze ulcer healing by measuring the size of digital ulcers and their count and analyze the effect of sildenafil on angiography.