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Scleroderma, Localized clinical trials

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NCT ID: NCT04610788 Recruiting - Scleroderma Clinical Trials

Cardiac Assessment by PV Loop in IPAH and Scleroderma PAH

CALIPSO
Start date: April 15, 2019
Phase:
Study type: Observational

This observational study is being done to understand why people with scleroderma can develop pulmonary arterial hypertension (high blood pressure in the lungs, abbreviated PAH) and a weak heart muscle (heart failure). The study will also help the investigators understand why people with PAH from an unknown cause (called idiopathic PAH, or IPAH) can also develop a weakened heart muscle. The response of the right side of the heart or right ventricle (RV) to standard PAH therapy in scleroderma-associated PAH and in IPAH will be assessed. Blood and tissue samples will be collected from research participants during participants' normal standard of care procedures. People with scleroderma-associated PAH or idiopathic cause (IPAH) who need a right heart catheterization may join this study.

NCT ID: NCT04535245 Recruiting - Scleroderma Clinical Trials

Lung Clearance Index to Identify Scleroderma Patients at Risk for ILD

Start date: January 4, 2021
Phase:
Study type: Observational

This National Jewish Health (NJH) Investigator Initiated pilot study funded by the Shah Foundation will prospectively perform a non invasive lung function test called Lung Clearance Index (LCI) to determine if 50 scleroderma patients without evidence of lung disease who have evidence of small airway inflammation or impairment to airflow are more likely to develop ILD than those with normal vales.50 subjects will be enrolled from the Rheumatology practice at NJH and followed with phone interviews or Electronic Medical Record (EMR) record review yearly times 5 to determine if they have subsequently developed evidence of ILD or pulmonary artery hypertension.

NCT ID: NCT04464434 Recruiting - Systemic Sclerosis Clinical Trials

Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis

UPSIDE
Start date: September 17, 2020
Phase: Phase 4
Study type: Interventional

HSCT has been implemented in (inter)national treatment guidelines for diffuse cutaneous systemic sclerosis (dcSSc) and is offered in clinical care and reimbursed by national health insurance in several European countries. However, data and specific guidelines on the best timing of HSCT in the course of dcSSc are lacking. In particular, it is unclear whether HSCT should be positioned as upfront therapy or as rescue treatment for patients not responding to conventional immunosuppressive therapy. This multicentre, randomized, open label trial aims to compare two treatment strategies used in usual care: upfront autologous HSCT versus usual care with (intravenous (i.v.) cyclophosphamide (CYC) pulse therapy followed by mycophenolate mofetil (MMF) and HSCT as rescue option).

NCT ID: NCT04319120 Recruiting - Clinical trials for Scleroderma, Systemic

Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma

POPSUD
Start date: December 17, 2020
Phase:
Study type: Observational

To make an updated inventory of digital ulcer care protocols in scleroderma patients and to specify the French data on monthly healing rates and local care with patients in care centers experience, and thus to know the impact of ulcers in different dimensions To evaluate the rate of healed digital ulcers at the end of the study

NCT ID: NCT04264728 Recruiting - Generalized Morphea Clinical Trials

Adult-onset Generalized Morphea

MORPHEA
Start date: December 1, 2019
Phase:
Study type: Observational

This study aimed to describe the demographical and clinical characteristics of a retrospective cohort of adult-onset GM and to investigate whether these findings differ between patients with an isomorphic and a symmetric pattern of lesion distribution.

NCT ID: NCT04200755 Recruiting - Clinical trials for Localized Scleroderma

Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma

DupiMorph
Start date: May 19, 2020
Phase: Phase 2
Study type: Interventional

The DupiMorph study evaluates the efficacy of Dupilumab in localized scleroderma patients. Dupilumab is approved in the US and EU for the treatment of moderate/severe atopic dermatitis and since 2018 in the US for severe asthma therapy.

NCT ID: NCT04148716 Recruiting - Clinical trials for Scleroderma, Systemic

microRNAs in Systemic Scleroderma

Dig-ScS
Start date: January 11, 2021
Phase:
Study type: Observational

No studies have investigated the expression of miRNAs in Dig-ScS tissues. In the absence of specific treatment for this frequent impairment in this connectivity, the team proposes to study miRNA profiles in the esophagus and duodenum to identify new therapeutic targets. The team is studying the involvement of pro-fibrotic "key" miRNAs called "FibromiRs", including 3 miRNAs from the DNM3os locus (miR-199a-3p, miR-199a-5p and miR-214 - characterized by the host laboratory) associated with monitoring the response to TGF-β in fibroblasts and their potential interaction with pharmacological treatments such as nintedanib and/or PPARγ agonists. The approach is part of a pilot study that can lead to a larger project after validation of the hypotheses. It also seems interesting to make a precise anatomopathological description with a gradation of the digestive fibrotic damage in view of the paucity of medical literature in this field

NCT ID: NCT03726398 Recruiting - Clinical trials for Pulmonary Hypertension

CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH

CRUSADE
Start date: September 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Patients with interstitial lung disease (ILD) and scleroderma who develop pulmonary hypertension (PH) do not fit well into the current classification system and treatments for pulmonary hypertension. This study aims to better understand patients with ILD-PH and scleroderma and to determine if treatment with Macitentan is beneficial.

NCT ID: NCT02682511 Recruiting - Autoimmune Diseases Clinical Trials

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).

NCT ID: NCT01808937 Recruiting - Morphea Clinical Trials

Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository

MAC
Start date: May 2007
Phase:
Study type: Observational [Patient Registry]

The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically: - How morphea behaves over time - How frequently specific problems occur along with morphea (for example, arthritis) - Whether morphea has an autoimmune background