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Scleroderma, Systemic clinical trials

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NCT ID: NCT05103553 Not yet recruiting - Systemic Sclerosis Clinical Trials

What is the Optimal Follow-up for Patients With Systemic Sclerosis?

PRASSc
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a complex multisystem rheumatic autoimmune disease. Currently, evidence based guidelines for frequency and intensity of follow-up of SSc patients are not available. Based on expert consensus annual extensive evaluation is recommended. To provide comprehensive multidisciplinary care integrated with evaluation of organ involvement and as such, reducing health care utilization while improving the quality of care for the patient, the "Leiden Combined Care in SSc (CCISS) pathway" was started in 2009. Data collected on disease progression in the patients that participate in this care pathway show that 50% of the patients have relatively mild disease, without any disease progression over time. Therefore there is a need for tailor made care in SSc patients in accordance to disease activity. To enable this, a prediction model was developed that can identify patients with low risk for disease progression.

NCT ID: NCT04996082 Not yet recruiting - Clinical trials for Validation of Raman Spectroscopy Usefulness in Systemic Sclerosis

Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis

RAMSES
Start date: October 2021
Phase:
Study type: Observational

Systemic sclerosis (SSc) is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis. Most of patients develop skin fibrosis gradually spreading. Two clinical distinct forms are described according to the extension of skin fibrosis: limited (lSSc) and diffuse (dSSc) SSc. It is now admitted that a spreading of skin fibrosis is associated with poor prognosis. This disease can be complicated by pulmonary arterial hypertension (PAH), interstitial lung disease (ILD) and scleroderma renal crisis (SRC) representing the main causes of death in SSc. Usually, PAH is associated with lSSc, and ILD and SRC are associated with dSSc. Prognosis is also different regarding skin phenotype with a higher mortality rate in dSSc. An easy score, called modified Rodnan skin score, is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis, but this score is hardly reproducible. Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score. Nevertheless, non-invasive analysis of fibrosis composition in different areas is not possible with these two technics. Thus, in this study we will investigate Raman spectroscopy, a non-invasive technic based on the interaction of a low-intensity laser with matter.

NCT ID: NCT04986605 Not yet recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess feasibility, safety and preliminary efficacy of Extracorporeal Photopheresis in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc). This pilot study will help to determine if further study (a RCT) is justified.

NCT ID: NCT04986514 Not yet recruiting - Systemic Sclerosis Clinical Trials

Implementation of a Biological Sample Collection in Systemic Sclerosis Patients

SCLERO-BIOBANK
Start date: April 2023
Phase:
Study type: Observational

Systemic sclerosis (SSc) is the most severe of the systemic autoimmune diseases. It is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). There are currently no validated prognostic biomarkers for the progression of SSc, yet it is crucial to better predict the progression of SSc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). Furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. The internal medicine department of the Lille University Hospital is a national and European reference center for the management of patients with SSc. Nearly 500 patients are followed annually in the internal medicine department. As part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the Lille University Hospital for a complete assessment of their SSc. This assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. The purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. The main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of SSc patients.

NCT ID: NCT04966416 Not yet recruiting - Systemic Sclerosis Clinical Trials

Calcinosis Reduction by Pyrophosphate in SSC

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.

NCT ID: NCT04563481 Not yet recruiting - Rehabilitation Clinical Trials

Effectiveness of Telerehabilitation on Scleroderma

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

The effects of exercises performed by telerehabilitation on individuals with hand-affected scleroderma on range of motion, grip strength, function, sensation, daily life activities and general health will be compared with the effects of traditional physiotherapy practices.

NCT ID: NCT04515706 Not yet recruiting - Clinical trials for Systemic Sclerosis, Diffuse

Iguratimod in Systemic Sclerosis

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.

NCT ID: NCT04303208 Not yet recruiting - Systemic Sclerosis Clinical Trials

Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis

Start date: September 2022
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.

NCT ID: NCT04223817 Not yet recruiting - Systemic Sclerosis Clinical Trials

7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis

PREM'S
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a rare systemic autoimmune disease with specific osteoarticular pattern of unknown mechanism. Ischemic phenomenon have been suggested to participate to the osteoarticular involvement in SSc. To date, osteoarticular pattern and hand vascular involvement have been few studied in magnetic resonance imaging in SSc, and most often with low resolution RMI. 7 Tesla RMI allows high resolution for morphology examination, together with dynamic and functional vascular study and sodium articular concentration. Indeed, the aim of the study is to describe hand osteoarticular and vascular involvement in SSc, as well as sodium articular concentration. Clinico-biological association will be also assessed.

NCT ID: NCT03858842 Not yet recruiting - Clinical trials for Lung Diseases, Interstitial

Non-interventional Study Describing Epidemiology, Prognosis and Patient Healthcare Costs in France, 2010-2017

PROGRESS
Start date: March 2019
Phase:
Study type: Observational

Interstitial lung diseases (ILDs) are a heterogeneous group of disorders, which encompass a wide range of conditions. In some patients with fibrosing ILDs, a progressive phenotype similar to that observed in idiopathic pulmonary fibrosis (IPF) may develop during the course of the disease (PF-ILD), including patients with systemic sclerosis (SSc)-related ILD. The aim of the study is to estimate the incidence and prevalence and to describe the characteristics of patients diagnosed with non-IPF PF-ILD and SSc-ILD, to describe the natural course of disease, and to explore the correlation between mortality and Forced Vital Capacity (FVC) of the patients with non-IPF PF-ILD. This study will be based on two data sources: the French national medico administrative database (SNDS) and the ILD cohort from the National French center for rare pulmonary diseases in Lyon, France.