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Scleroderma, Diffuse clinical trials

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NCT ID: NCT02290613 Completed - Clinical trials for Pulmonary Hypertension

Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH)

EDITA
Start date: July 1, 2014
Phase: Phase 2
Study type: Interventional

Trial Design Patients with borderline PAH indicated by borderline mPAP values will be included in this single centre study. This clinical investigation is performed as a Proof-of-Concept (PoC) investigator initiated trial (IIT) using a prospective, randomized, double-blind, parallel group, placebo-controlled, phase IIA clinical study design. On their first visit their medical history will be obtained and physical examination will be conducted. Moreover, an electrocardiogram (ECG), laboratory testing (NT-proBNP, uric acid and other laboratory tests), echocardiography at rest and right heart catheterization will be carried out. If patients have been identified within the last 6 months before screening investigations by right heart catheterization, the measurements are considered valid as baseline investigations and will not be repeated. If patients fulfill the inclusion criteria and still suffer from borderline mPAP values they will be invited to join the study. The clinical investigations will begin within 28 days. The prospective study will comprise a 6 months study period (180 ±2 weeks) plus the screening phase up to 28 days and a follow-up phase of 30 ±7 days.

NCT ID: NCT02283762 Completed - Clinical trials for Scleroderma, Systemic

Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis

Start date: January 15, 2015
Phase: Phase 2
Study type: Interventional

To investigate if Riociguat is effective in the treatment of systemic sclerosis

NCT ID: NCT02278445 Withdrawn - Clinical trials for Pulmonary Hypertension

Evaluation of Pulmonary Doppler Signals in Patients With Systemic Sclerosis(SSc)

Start date: November 2014
Phase: N/A
Study type: Interventional

Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.

NCT ID: NCT02264405 Recruiting - Autoimmune Diseases Clinical Trials

Autologous SCT for Progressive Systemic Sclerosis: a Prospective NIS Study

NISSC
Start date: December 2012
Phase: N/A
Study type: Observational

To assess the effectiveness of Autologous Hematopoietic Stem Cell transplantation (AHSCT) for early severe or rapidly progressive Systemic Sclerosis (SSc) as currently performed by different study protocols used across Europe in various EBMT centres through the careful recording and analysis of routinely collected clinical and biological data.

NCT ID: NCT02260557 Completed - Clinical trials for Raynaud's Phenomenon Secondary to Systemic Sclerosis

Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis

Start date: October 2014
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to determine the activity of selexipag on Raynaud attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc).

NCT ID: NCT02246348 Terminated - Clinical trials for Pulmonary Hypertension

Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)

Start date: September 2014
Phase: N/A
Study type: Interventional

Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.

NCT ID: NCT02243111 Terminated - Clinical trials for Pulmonary Hypertension

Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound

Start date: September 2014
Phase: N/A
Study type: Interventional

Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.

NCT ID: NCT02228850 Completed - Clinical trials for Raynaud's Phenomenon Secondary to Systemic Sclerosis

Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

Start date: November 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).

NCT ID: NCT02213705 Completed - ADULT Clinical Trials

Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells

MSC
Start date: May 6, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment will be given to patients with a rapidly evolutive disease or refractory to cyclophosphamide.

NCT ID: NCT02212249 Completed - Systemic Sclerosis Clinical Trials

Soluble VE-cadherin and VE-cadherin Antibody in Sclerodermic Sclerosis

Sclerocadh1
Start date: May 2014
Phase: N/A
Study type: Interventional

Ve-cadherin is expressed in endothelial cells. Systemic slerosis is a rare auto-immune disease with a endothelial dysfunction. This study is to evaluated the level of soluble VE-cadherin and VE-cadherin antibody in patients with systemic slerosis.