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Scleroderma, Systemic clinical trials

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NCT ID: NCT02733978 Completed - Scleroderma Clinical Trials

Ozone Therapy in the Treatment of Digital Ulcers in Patients With Systemic Sclerosis

Start date: June 2016
Phase: N/A
Study type: Interventional

Digital ulcers (DUs) in scleroderma result from recurrent Raynaud's phenomenon (RP) and microtrauma with high impact on quality of life, management of DUs is a great challenge for clinicians. Medical use of ozone (triatomic oxygen) was initiated in the 19th century. Ozone has multiple therapeutic effects in wound healing due to the property of releasing nascent oxygen, which has been shown to stimulate antioxidant enzymes.

NCT ID: NCT02682511 Recruiting - Autoimmune Diseases Clinical Trials

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).

NCT ID: NCT02663895 Completed - Systemic Sclerosis Clinical Trials

Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis

Start date: October 2016
Phase: Phase 2
Study type: Interventional

This is a prospective open-label trial that will enroll 12 patients with systemic sclerosis (SSc) and at least one calcinotic lesion of the hands that is palpable on physical examination and also measureable on hand radiographs, at one single center. Each subject will receive treprostinil orally for 12 months, and follow-up evaluations will be performed every 3 months. Our main objective is to determine whether oral treprostinil is safe, and effective in reducing calcinosis in patients with SSc. We hypothesize that calcinosis is a result of microvascular injury and ischemic damage, and that therefore treprostinil may be beneficial in the treatment of calcinosis in patients with SSc.

NCT ID: NCT02655640 Completed - Clinical trials for Lupus Erythematosus, Systemic

The Impact of Illness Perceptions on Health Related Outcomes in Patients With Lupus and Systemic Sclerosis

Start date: October 2015
Phase: N/A
Study type: Observational

This research project has the overall objective to investigate the direction of the associations between illness perceptions, their influencing factors and health-related outcomes. Moreover, the investigators want to look at the direction of the associations between illness perceptions and health related outcomes such as psychological and physical functioning in patients with Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis (SSc). The investigators want to know whether the outcome variables anxiety, depression, physical (dis) functioning are influenced by illness perceptions or vice versa. Not only the patients' illness perceptions but also the illness perceptions of the General Practitioners (GP) and rheumatologists will be investigated. The researchers want to know if the doctors' perceptions have an impact on the physical and psychological functioning of the patient or vice versa. Much research in the field of illness perceptions is cross-sectional in nature which means that the direction of the relationships between variables is not known.

NCT ID: NCT02642146 Terminated - Systemic Sclerosis Clinical Trials

Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study

Start date: January 2015
Phase:
Study type: Observational [Patient Registry]

This study evaluates the efficacy and safety of routine medical treatments of digital ulcers in patients with systemic sclerosis in a prospective cohort study.

NCT ID: NCT02636127 Completed - Clinical trials for Scleroderma, Systemic

Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis

Start date: December 7, 2015
Phase: N/A
Study type: Interventional

Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage, cutaneous and visceral fibrosis and a dysimmune condition. Therapies in this disease remain insufficient and the complications resulting from organs involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved in the vascular damage of the SSc. However mechanisms at the onset of this endothelial cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune populations. The purpose of the project is to define the role displayed by cytotoxic, circulating immune populations of SSc patients in endothelial cytotoxicity as well as the role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune cytotoxic cells and the endothelium.

NCT ID: NCT02610842 Completed - Scleroderma Clinical Trials

Hands on - a Hand Care Guide in Systemic Sclerosis

Start date: January 2015
Phase: N/A
Study type: Interventional

Hands are commonly affected in Systemic Sclerosis (SS). The objective of this research is to apply a home based hand care guide in patients with SS and to evaluate its response regarding hand pain, function, strength and mobility.

NCT ID: NCT02597933 Completed - Clinical trials for Scleroderma, Systemic

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

Start date: November 12, 2015
Phase: Phase 3
Study type: Interventional

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

NCT ID: NCT02588625 Withdrawn - Scleroderma Clinical Trials

A Double-Blinded Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986020 Versus Placebo in Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Start date: February 2016
Phase: Phase 2
Study type: Interventional

This is a two part study. The purpose of Part A is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using one dose of BMS-986020. The purpose of Part B is to determine if BMS-986020 is effective in treatment of diffuse cutaneous systemic sclerosis using two different doses of BMS-986020.

NCT ID: NCT02562079 Completed - Systemic Sclerosis Clinical Trials

Vasculopathy, Inflammation and Systemic Sclerosis

VISS
Start date: March 2012
Phase: N/A
Study type: Interventional

It is a study of basic research with mechanistically objectives and including clinical biological samples.