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Scleroderma, Systemic clinical trials

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NCT ID: NCT03867097 Completed - Clinical trials for Raynaud Phenomenon Secondary to Systemic Sclerosis

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 2)

Start date: March 4, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, double-blind, randomized, placebo-controlled study to evaluate the effect of iloprost on the symptomatic relief of Raynaud's Phenomenon attacks in subjects with symptomatic Raynaud's Phenomenon secondary to Systemic Sclerosis.

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.

NCT ID: NCT03856853 Recruiting - Clinical trials for Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)

Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the eEfficacy and safety of pirfenidone in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

NCT ID: NCT03844061 Recruiting - Systemic Sclerosis Clinical Trials

Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Start date: July 29, 2019
Phase: Phase 2
Study type: Interventional

This is a 52 week, single center, randomized, double-blind, placebo-controlled study. After patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month, they will be randomized to treatment with either Belimumab & Rituximab or placebo.Patients in both groups will be on background MMF for the entirety of the study. Belimumab will be administered subcutaneously and Rituximab intravenously. Placebo injections and infusions will be of normal saline. Randomization will be done in a 2:1 manner to favor the treatment group. It is hypothesized that that Rituximab and Belimumab combination therapy with Mycophenolate Mofetil background therapy will improve fibrosis in SSc skin when compared to treatment with placebo and Mycophenolate Mofetil in a group of patients with early dcSSc.

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: NCT03819777 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Volatile Organic Compounds (VOCs) as a Biomarker in Immune-mediated Pulmonary Arterial Hypertension (PAH)

VOC-PAH
Start date: March 1, 2018
Phase:
Study type: Observational

Aim: to investigate the role of inflammation and auto-immunity in pulmonary arterial hypertension by using the profile of volatile organic compounds. Hypothesis: first, the investigators hypothesize that at time of diagnosis the VOC profiles will discriminate patients with PAH-CTD and idiopathic PAH (IPAH) from patients with systemic sclerosis or systemic lupus erythematosus (CTD) without PAH, supporting the contention that there is a overlapping inflammatory and auto-immune pathway in PAH. During follow-up, the investigators will measure the VOC profiles of patients in all three groups who will be treated according standard clinical care. The hypothesis is that VOC profiles are affected by therapy.

NCT ID: NCT03817424 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

Start date: December 13, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis.

NCT ID: NCT03816345 Recruiting - Clinical trials for Rheumatoid Arthritis

Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

Start date: July 16, 2019
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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: NCT03798366 Completed - Systemic Sclerosis Clinical Trials

A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis

NOVESA
Start date: January 14, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of the study is to see if GLPG1690 helps (together with the standard of care treatment) in the treatment of the skin and other areas affected by systemic sclerosis. Another aim is to find out how safe/well tolerated GLPG1690 will be and whether there are any side effects. The study will also look at other things, including whether the study drug affects disease progression and also if it changes any aspect of the quality of life.