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Scleroderma, Systemic clinical trials

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NCT ID: NCT04325217 Active, not recruiting - Clinical trials for Lung Diseases, Interstitial

Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Start date: April 15, 2020
Phase:
Study type: Observational

The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.

NCT ID: NCT04219592 Active, not recruiting - Systemic Sclerosis Clinical Trials

IgG-4 Levels in Systemic Sclerosis

SSc-IgG4
Start date: May 30, 2019
Phase:
Study type: Observational

This is an observational - non interventional study. The investigators will compare IgG4 levels of 80 healthy donors (from Israel blood bank - MDA) and 80 Systemic Sclerosis patients from Meir Medical Center.

NCT ID: NCT04206644 Active, not recruiting - Systemic Sclerosis Clinical Trials

Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages

SCLERO JAK
Start date: January 21, 2021
Phase:
Study type: Observational

The Sclero-JAK project aims to assess the impact of a JAK1/2 inhibitor (ruxolitinib) on activation states of monocytes-derived macrophages (MDM) from systemic sclerosis (SSc) patients

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

NCT ID: NCT03831438 Active, not recruiting - Clinical trials for Scleroderma, Diffuse

Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis

Start date: January 1, 2019
Phase: Phase 1
Study type: Interventional

Several lines of evidence place TGF-β, a potent pro-fibrotic cytokine, at the centre of the pathogenesis of Systemic Sclerosis (SSC). AVID200 is a novel inhibitor of TGF-β ligands. This Phase 1 trial is designed to evaluate the safety, tolerability and preliminary efficacy of AVID200 in SSc patients in order delineate doses to be further evaluated in Phase 2. Approximately 9 to 24 male and female patients with documented SSc (i.e., score ≥ 9 according to the American College of Rheumatology/European League Against Rheumatism classification criteria), and classified as having the diffuse cutaneous SSs (dcSSc) subset (i.e., according to the LeRoy and Medsger Classification), will be entered into this Phase 1a, multicentre, open-label, dose-escalation, cohort study of AVID200.

NCT ID: NCT03816189 Active, not recruiting - Systemic Sclerosis Clinical Trials

Role of Eosinophil in Fibrogenesis of Systemic Sclerosis

EOFIB-SSC
Start date: October 3, 2018
Phase:
Study type: Observational

Eosinophils are involved in tissue remodeling and fibrosis in many inflammatory diseases. Systemic sclerosis (SSc) is an autoimmune disease with fibrotic skin and lung complications. The profibrosing properties and data from the SSc literature suggest a possible role of the eosinophils in the process of fibrogenesis of SSc.

NCT ID: NCT03340194 Active, not recruiting - Systemic Sclerosis Clinical Trials

Evaluation of Calcinosis in Systemic Sclerosis

CALCIDERMIS
Start date: November 30, 2017
Phase:
Study type: Observational

Systemic sclerosis is a rare pathology characterized by fibrosis and vascular lesion with skin, pulmonary, digestive and cardiac localisation. Calcinosis cutis is commonly described, but its prevalence and appear few documented in literature. Moreover, this studies used clinical observation to determine presence or absence of calcification, and rarely radiography, in particular for feet localisation. In the same way, skin calcification and organ injury association appear unclear. The aim of the study is firstly to determine prevalence of calcinosis cutis, with hand and feet radiography realisation in a cohort of systemic sclerosis patient. Secondly, will be determine the correlation between calcinosis and organ injury.

NCT ID: NCT02165111 Active, not recruiting - Scleroderma Clinical Trials

Efficacy of Botulinum Toxin In Scleroderma-Associated Raynaud's Syndrome

Start date: January 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in one randomly-selected hand, and the contralateral hand will be injected with sterile saline (placebo) to serve as a control. Study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging to assess blood flow. After this initial assessment, the patients will undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline solution (placebo) in the other, in a randomized, blinded manner. Patient will report the severity of their Raynaud's symptoms weekly over the four month study period. At one month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. At four months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition, patient will be given the option of one week post-injection visit, at which point the same assessment will be performed. At the conclusion of the study, unblinding will occur.

NCT ID: NCT01895244 Active, not recruiting - Scleroderma Clinical Trials

Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis

AST-MOMA
Start date: September 2012
Phase: Phase 2
Study type: Interventional

Autologous stem cell therapy has been shown to be effective in patients with systemic sclerosis. Nevertheless treatment is associated with treatment related mortality and patients die during follow up despite successful transplantation. Intention of this trial is to improve overall survival by modifying the existing protocol used for the ASTIS trial. To reduce treatment toxicity we reduce the dose of Cyclophosphamide (CYC) for mobilisation to 2x1g. Especially in patients with cardiac manifestations we also modify the conditioning regimen by adding thiotepa and reducing CYC; as CYC has known cardiotoxic side effects.

NCT ID: NCT01804959 Active, not recruiting - Systemic Sclerosis Clinical Trials

Clinical Trial of Probiotics in Systemic Sclerosis Associated Gastrointestinal Disease

Start date: May 2013
Phase: Phase 2
Study type: Interventional

SSc-associated gastrointestinal (GI) involvement is common, with no effective treatment. Probiotics may have beneficial effects on symptoms as supported by one small open-label study (n=10) that demonstrated decreased bloating symptoms in SSc patients after 2 months of probiotics. This study aims to determine (i) whether 60 days of Vivomixx probiotics result in greater GI symptom improvement than placebo in SSc outpatients, assessed using an interview-administered 34-item Gastrointestinal Tract (GIT) questionnaire and (ii) whether 60 days versus 120 days of probiotics result in greater GI symptom improvement in SSc outpatients, assessed using the GIT questionnaire.