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Scleroderma, Systemic clinical trials

View clinical trials related to Scleroderma, Systemic.

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NCT ID: NCT03294616 Completed - Gastroparesis Clinical Trials

Transcutaneous Electroacupuncture for Gastric Complications of Scleroderma

Start date: February 6, 2017
Phase: N/A
Study type: Interventional

An innovative method of needleless transcutaneous electroacupuncture (TEA) using a newly developed watch-size stimulator is proposed. Weak electrical current will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions. The stimulator can be attached to the skin near the acupuncture points and therefore daily activity of the patient does not need to be altered. Two experiments are designed to prove the feasibility of the proposed therapy for gastric complications of Scleroderma .

NCT ID: NCT03274076 Completed - Systemic Sclerosis Clinical Trials

Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)

TOFA-SSc
Start date: September 25, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This Phase I/II placebo controlled trial will evaluate tofacitinib in subjects with diffuse cutaneous systemic scleroderma (dcSSc). This trial is intended to provide safety, and tolerability data in participants with dcSSc when dosed to target exposures similar to that used in adult participants with rheumatoid arthritis.

NCT ID: NCT03271320 Completed - Systemic Sclerosis Clinical Trials

Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis

SCLERO-ESTHET
Start date: December 19, 2016
Phase:
Study type: Observational

The primary objective is to assess the burden of aesthetic complication in systemic sclerosis. Systemic sclerosis is associated with changes in skin aspect which can impact the appearance. Aesthetic burden will be assessed through several scales and compared to a control group of health subjects.

NCT ID: NCT03262922 Completed - Clinical trials for Systemic Scleroderma

Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment

PRESSY
Start date: July 29, 2016
Phase:
Study type: Observational

The aim of the study is to compare the exposure to environmental and professional toxics by patients with systemic scleroderma and by patients not achieved by this pathology.

NCT ID: NCT03222492 Completed - Scleroderma Clinical Trials

Brentuximab Vedotin for Systemic Sclerosis

BRAVOS
Start date: September 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on activated immune cells There is evidence for CD30 involvement in SSc. This study represents the first step in determining safety and tolerability of brentuximab vedotin in SSc.

NCT ID: NCT03221257 Completed - Clinical trials for Interstitial Lung Disease

Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

SLSIII
Start date: November 28, 2017
Phase: Phase 2
Study type: Interventional

A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD).

NCT ID: NCT03207997 Completed - Scleroderma Clinical Trials

MRI Quantification of Pulmonary Fibrosis in Scleroderma Patients

IRMSCLERO
Start date: September 18, 2017
Phase: N/A
Study type: Interventional

Assessment of pulmonary fibrosis is currently based on high-resolution CT (HRCT) and pulmonary function tests (PFT) such as forced vital capacity, (FVC) and carbon monoxide diffusion (DLCO). These techniques allow a semi-quantitative analysis of the pulmonary disease but are imperfect. The mains weaknesses are the lack of reproducibility, the limited sensitivity and for CT the resulting radiation dose. Recent advances in MRI sequences allow exploring the lung parenchyma with millimeter slice thickness. Development of computer-assisted post-processing such as elastic registration opens new perspectives in the functional study of the lung parenchyma, especially the analysis of its deformation during the respiratory cycle and therefore of its elasticity. Pulmonary involvement in scleroderma is present in 70 to 100% of patients and is the leading cause of death. Initial assessment of pulmonary involvement and follow-up are important for therapeutic decisions and patient prognosis. Quantitative analysis should be developed to reliably evaluate pulmonary fibrosis and increase the reproducibility. The purpose of our study is to evaluate the feasibility of quantifying pulmonary fibrosis by successively performing full inspiration then full expiration volumetric MR acquisitions using a VIBE - Volumetric Interpolated Breath-hold examination sequence. Post processing of the 2 volumes using elastic registration is performed to evaluate pulmonary deformation in the normal and fibrotic lung areas, hypothesizing that it would be different.

NCT ID: NCT03198689 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis

Start date: May 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess feasibility, safety and preliminary efficacy of Brentuximab vedotin (Adcetris), a CD30-directed antibody-drug conjugate, in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc).

NCT ID: NCT03141125 Completed - Scleroderma Clinical Trials

The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy

Start date: January 2016
Phase: N/A
Study type: Interventional

Study about the effect of ethanol extract physalis angulate in scleroderma patients with standard therapy to reduce skin fibrosis based on modified Rodnan Skin Score, reduce inflammation, immunological response and fibrosis: A Randomized Clinical Placebo ControlledTrial with a prospective cohort study on scleroderma outpatient clinic in Cipto Mangunkusumo Hospital in Jakarta and Hasan Sadikin Hospital in Bandung, from January 2016 to July 2017

NCT ID: NCT03120533 Completed - Clinical trials for Scleroderma, Systemic

Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study

TISSUE-PoC
Start date: June 20, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The study is conducted to confirm the good tolerance of a continuous cathodal iontophoresis of the treprostinil hydrogel administered during 10 days on the pulp of the finger of healthy volunteer and on the ischemic digital ulcerations of Systemic Sclerosis patients, particularly to estimate the cutaneous tolerance of the procedure and the effect on the blood pressure.