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Scleroderma, Systemic clinical trials

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NCT ID: NCT05016804 Recruiting - Systemic Sclerosis Clinical Trials

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis

Start date: July 4, 2022
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Systemic Sclerosis

NCT ID: NCT05007340 Recruiting - Clinical trials for Systemic Lupus Erythematosus

ILD-SARDs Registry and Biorepository

ILD-SARDs
Start date: August 24, 2021
Phase:
Study type: Observational [Patient Registry]

A complex interaction between demographic, environmental and genetic mechanisms impact the onset, severity and outcome of ILD-SARDs through dysregulation of the immune system and lung pro-biotic pathways. Comorbidity and genetic risk indicate that there are overlapping pathogenic mechanisms among SARDs, some of which underlie ILD in different SARDs. The purpose of this biobank is to study the clinical, pathological, laboratory, and imaging characteristics of SARDs patients with lung involvement. This will help identify as unique features underlying lung involvement in SARDs. In addition, this may lead to the discovery of novel mechanisms of disease and potentially novel targets of treatment for SARDs patients with lung disease.

NCT ID: NCT04995588 Recruiting - Systemic Sclerosis Clinical Trials

Systemic Sclerosis and Innate T Cells

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

Innate T cells (ITC) are decreased in systemic sclerosis (SS) and an early lymphocyte innateness has been reported. In the other part, ITC are implicated on inflammatory process, including the IL-33/ST2 axis, which is also involved in ScS endotheliopathy. Data are however scarce and physiopathological mechanisms have not been assessed to date. The investigators hypothesize a global lymphocyte innateness in SSc, linked to a chronic ITC stimulation by innate signals leading to ITC exhaustion, and their potential role in endotheliopathy and fibroblast activation in SSc.

NCT ID: NCT04971018 Recruiting - Systemic Sclerosis Clinical Trials

Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis Systemic Sclerosis

AVADIS
Start date: November 9, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of transcutaneous auricular vagus nerve stimulation (ta-VNS) on gastrointestinal symptoms and quality of life in systemic sclerosis (SSc) patients.

NCT ID: NCT04917705 Recruiting - Systemic Sclerosis Clinical Trials

Search for Diagnostic and Prognostic Biomarkers in Systemic Sclerosis and Inflammatory Myopathies

SCLEROMYOMICS
Start date: November 25, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis and inflammatory myopathies, which sometimes combine (scleromyositis), have shared pathophysiological elements. In both diseases, many cell subtypes are involved in damage to organs such as T lymphocytes, B lymphocytes, and unconventional (non-B, non-T) lymphocytes called innate lymphoid cell (ILC). The increasing complexity of our understanding of the immune system (multiplication of recognized cell subtypes) also makes the strategies for analyzing pathophysiological mechanisms more complex. Currently, no biomarker perfectly predicts the phenotype and evolution of patients. Multi-OMIC analyzes will be performed (identification of cell populations as well as genomic, transcriptomic and proteomic characterization) in blood and tissue samples (skin and muscle biopsy) in patients with systemic sclerosis and inflammatory myopathies, with the objective of identifying discriminating molecular signatures (biomarkers) according to the characteristics of the disease and its evolution.

NCT ID: NCT04917146 Recruiting - Systemic Sclerosis Clinical Trials

Systemic Sclerosis' Relatives Reflex

RelativReflex
Start date: June 23, 2021
Phase:
Study type: Observational

Systemic sclerosis (SSc) is a rare, serious disease that is part of chronic inflammatory rheumatism. It requires multidisciplinary care and a specific therapeutic patient education program. SSc actually affects every member of the family, the patient as well as those close to him. It deeply affects each member of the family (increased fatigue, stress, social isolation, exhaustion, financial difficulties …) which gives rise to threats of vulnerability and modulates the balance of family relations. However, there are very few studies on family SSc caregivers. We have raised the question about the experience and needs of caregivers in order to better support them. The main purpose of this pilot study is to better understand the particularities of relatives (caregivers) of patients suffering from systemic sclerosis and will allow us to refine our knowledge about the assistance they provide for SSc patients and its impact on family caregivers : - lived experience of the relatives (caregivers); - physical, mental and socio-professional health of the relatives (caregiver); - relationship between the relative (caregiver) and the patient. The research will be carried out at Cochin Hospital, in collaboration with the French Scleroderma Association (ASF). It will be offered to relatives of SSc patients identified by health team in the rheumatology or internal medicine department, as well as during consultations and patient education activities. An information note and an informed consent will be given to each patient and his caregiver ; Self-questionnaires will then be offered to relatives. They can fill them out while they are in the hospital, or at home and return the completed questionnaire. Caregivers will be questioned about their quality of life, health, relationship with the patient and support situation. They will also be asked for personal socio-demographic information concerning the patient. The "caregiver reflex" project is part of the 2020-2022 mobilization and support strategy for caregivers "acting for the health of family caregivers", in which the establishment of a "caregiver reflex" among professionals health is put forward.

NCT ID: NCT04804930 Recruiting - Clinical trials for Scleroderma, Systemic

Trichoscopy and Systemic Scleroderma

TRICHLOSCLERO
Start date: November 8, 2021
Phase:
Study type: Observational

- Few data are available on scalp involvement in systemic scleroderma. - Few data are available on the association between scalp abnormalities and features of systemic scleroderma - Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice - There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma

NCT ID: NCT04797286 Recruiting - Scleroderma Clinical Trials

Sildenafil for Early Pulmonary Vascular Disease in Scleroderma

SEPVADIS
Start date: September 20, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase II randomized, double-blind, placebo-controlled trial of sildenafil in men and women with Scleroderma with mildly elevated pulmonary pressures (SSc-MEP) to determine whether sildenafil may be an effective treatment for SSc-MEP.

NCT ID: NCT04791280 Recruiting - Systemic Sclerosis Clinical Trials

Study of the Intestinal Microbiota of Patients With Systemic Sclerosis

SCLEROMICROBIO
Start date: March 31, 2021
Phase:
Study type: Observational

The term gut microbiota describes the entire intestinal microbial communities. Studies have established the important role played by the gut microbiome in modulating vital functions of the healthy host. The physiological effects of the microbiota for the host are, for the most part, beneficial. In several pathologies, an imbalance in the composition of the microbiota has been demonstrated. Systemic sclerosis is an autoimmune, disorder of the connective tissue, characterized by vascular lesions, immunological abnormalities, and fibrosis of skin and internal organs As in many inflammatory diseases, there are painful digestive manifestations in systemic scleroderma that affect up to 90% of patients. The exact pathophysiology of the digestive involvement in systemic sclerosis is uncertain. The digestive manifestations of systemic sclerosis are frequent and can affect the entire digestive system. However, there are few studies of the intestinal microbiota in this disease, which seems to be part of the same continuum of diseases with abnormalities of innate immunity. By analogy with chronic inflammatory bowel diseases, particularly Crohn's disease, we have raised the question of the existence of dysbiosis during scleroderma which could lead to episodes of acute, severe and recurrent inflammation of the peritoneum under the influence of triggering factors. The long-term prospects would be to look for ways to prevent attacks or to treat them more rapidly and effectively by using therapeutic targets in the intestinal microbiota. The study population will be seen in the usual care setting, identically to all patients with systemic sclerosis treated in the department. In case of an inflammatory disease outbreak, and depending on its severity, the patient will be seen again in consultation or hospitalized. Appropriate complementary examinations (biology, imaging, endoscopy) will be carried out and the treatment adapted.

NCT ID: NCT04789850 Recruiting - Systemic Sclerosis Clinical Trials

Safety and Efficacy of Itacitinib in Adults With Systemic Sclerosis

SCLERITA
Start date: February 2, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether itacitinib is safe and effective in the treatment of systemic sclerosis in adults.