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Scleroderma, Diffuse clinical trials

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NCT ID: NCT04132206 Recruiting - Systemic Sclerosis Clinical Trials

Longitudinal Characterization of Microbial Signature in Systemic Sclerosis Patients

ScleroBiotique
Start date: October 8, 2019
Phase:
Study type: Observational

Today, the study of gut microbiota has taken a prominent place in several fields of medical research. Numerous experimental data in humans and animals suggest that an imbalance in the composition of the microbiota could contribute to the pathophysiology of systemic autoimmune diseases such as Systemic Sclerosis (SCS). A future exploration of the microbiota, a source of diagnostic and/or prognostic biomarkers, may be very useful for tomorrow's medicine by proposing therapeutic interventions based on the correction of possible imbalances in the intestinal flora. Studies of the human gut microbiota in patients with ScS are limited to low-impact investigations, due to the lack of data on the clinical and biological characterization of the patients studied, and to the absence of longitudinal studies in the same patient. For this reason, we are interested in exploring the intestinal microbiota of ScS patients in a comprehensive and longitudinal way.

NCT ID: NCT04118725 Completed - Systemic Sclerosis Clinical Trials

Muscular Respiratory Involvement and Systemic Sclerosis

SIROCO
Start date: October 21, 2019
Phase: N/A
Study type: Interventional

Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability. Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors. Diffuse fibrosing myopathy of bad prognosis have been reported in ScS.To now, muscular respiratory involvement has not been evaluated in ScS. Therefore, ScS patients (with or without dyspnea) could have underlying respiratory muscular involvement not detected by current standard of care with pulmonary function tests (PFT). This project is the first, to the best of our knowledge, to assess frequency of respiratory muscular involvement in ScS and to evaluate a screening strategy of this involvement.

NCT ID: NCT04095351 Recruiting - Systemic Sclerosis Clinical Trials

Connective Tissue Diseases and Lung Manifestations

Colipris
Start date: December 9, 2019
Phase:
Study type: Observational [Patient Registry]

Despite a number of prospective studies already initiated in the past years, the current epidemiology and course of interstitial lung disease (ILD) and pulmonary hypertension (PH) in patients with connective tissue disease (CTD) is still not well defined, particularly regarding its prevalence, incidence and the management of a broad spectrum of disease presentations. Major challenges include the identification of patients with progressive disease, the appropriate time point of therapeutic intervention and the underlying driver of disease (inflammatory or pro-fibrotic stimulus or both?). To address these issues in Western Austria, a progressive registry of patients with CTD exploring routine clinical and pathophysiological characteristics of ILD and PH will be conducted. This multidisciplinary, prospective and observational registry aims to collect comprehensive clinical data on incidence, prevalence and course of disease regarding all PH and ILD presentations in a real-world setting.

NCT ID: NCT04066842 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D in Systemic Sclerosis Patients With Periodontitis

Start date: November 1, 2015
Phase:
Study type: Observational

Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

NCT ID: NCT04045743 Completed - Clinical trials for Scleroderma, Systemic

The Benefit of Bermekimab in Patients With Systemic Sclerosis

Start date: July 19, 2019
Phase: Phase 2
Study type: Interventional

This is a proof-of concept RCT trying to generate evidence that inhibition of IL-1α through the administration of bermekimab may inhibit progression of SSc.

NCT ID: NCT04040322 Completed - Clinical trials for Raynaud's Phenomenon Secondary to Systemic Sclerosis

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)

Start date: October 14, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with systemic sclerosis.

NCT ID: NCT04001556 Completed - Systemic Sclerosis Clinical Trials

RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)

REUSSI-SSc
Start date: December 2, 2019
Phase: N/A
Study type: Interventional

As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential alterations of echostructure of major salivary glands and the fibrosis of Salivary Glands in this disease.

NCT ID: NCT03976648 Terminated - Systemic Sclerosis Clinical Trials

A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis

Start date: July 18, 2019
Phase: Phase 2
Study type: Interventional

This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period.

NCT ID: NCT03965780 Completed - Clinical trials for Scleroderma, Systemic

The SPIN - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)

SPIN-SSLED
Start date: September 23, 2019
Phase: N/A
Study type: Interventional

Many people living with scleroderma, a rare autoimmune connective tissue disease, attend support groups to help them cope with the disease. Support groups provide a safe environment where people facing a similar challenge can come together to share disease-related experiences and exchange practical and emotional support. This is especially important for rare diseases such as scleroderma as organized support services can be limited. However, many people with scleroderma do not have access to scleroderma support groups, and many support groups that are initiated are not sustained due to a number of obstacles. Leaders of these support groups play a particularly important role. They are responsible for a wide range of tasks including administrative details that go into planning meetings, facilitating effective and meaningful discussions, managing any issues that may arise in group dynamics, balancing their own needs with the needs of the group and many more. The Scleroderma Patient-centered Intervention Network (SPIN) team has worked with patient organizations and an advisory team of scleroderma support group leaders to develop the Support group Leader EDucation (SPIN-SSLED) Program for scleroderma support group leaders with the goals of (1) providing information and resources to leaders to help them feel more comfortable, confident and supported in their roles and (2) to provide people with the skills they need to establish scleroderma support groups where none exist. The SPIN-SSLED Trial will be used to evaluate the effectiveness of the SPIN-SSLED Program on scleroderma support group leaders' self-efficacy (primary outcome) in carrying out their leader tasks (which is defined as their perceived ability to carry out actions needed to be successful in support group leadership), burnout and emotional well-being.

NCT ID: NCT03957681 Active, not recruiting - Clinical trials for Moderate to Severe Systemic Sclerosis

A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis

Start date: May 23, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening