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Scleroderma, Diffuse clinical trials

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NCT ID: NCT06044844 Recruiting - Clinical trials for Efficacy of Tofacitinib in the Systemic Sclerosis

Effectiveness of Tofacitinib in Systemic Sclerosis

Start date: November 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare efficacy of tofacitinib with cyclophosphamide in skin thickening in early diffuse cutaneous systemic sclerosis .

NCT ID: NCT06037577 Completed - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects

Start date: March 5, 2019
Phase: Phase 1
Study type: Interventional

CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male volunteers.

NCT ID: NCT06032754 Completed - Clinical trials for PSVD With or Without SSc

PortoSinusoidal Vascular Diseases and Systemic Sclerosis

Start date: February 1, 2023
Phase:
Study type: Observational

Porto-Sinusoidal Vascular Disorders (PSVD) is a heterogeneous clinico-pathological entity characterized by alterations in small liver vessels. "Nodular regenerative hyperplasia (NRH)" is the most common PSVD. The most frequent liver disease associated with Systemic sclerosis (SSc) is primary biliary cholangitis reported in 2 to 22% of cases. NRH prevalence estimated to 1.4%, may be underestimated as NRH diagnosis is histologic and usually suspected in case of complications due to portal hypertension. Few data are available about NRH associated with SSc resulting in a lack of knowledge of the characteristics and outcome of these patients.

NCT ID: NCT06029335 Active, not recruiting - Healthy Clinical Trials

Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Start date: September 1, 2020
Phase:
Study type: Observational

Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases. Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.

NCT ID: NCT06019234 Recruiting - Clinical trials for Juvenile Systemic Sclerosis

Juvenile Systemic Sclerosis, a Retrospective Epidemiological Study on a French Cohort

JSSc
Start date: March 3, 2023
Phase:
Study type: Observational

Scleroderma is an inflammatory attack of the vessels leading to localized or multisystemic sclerosis. It is a rare autoimmune pathology in pediatrics. The incidence in pediatrics is very low (about 4 per million according to an American) and therefore the data on the pathology very poor, especially on the therapeutic level. The proposed immunosuppressive treatments are extrapolated from data in adults. The evolution of connectivity does not seem quite identical to the evolution of adult scleroderma, adaptation of treatments seems judicious. However, data on the evolution under therapy in children are still poor. Complications related to the pathology, iatrogeny and diagnostic delay are the first causes of mortality from this pathology and deserve to be studied and if possible avoided. The main hypothesis of the research being to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with systemic sclerosis.

NCT ID: NCT05995626 Recruiting - Scleroderma Clinical Trials

Hyaluronidase Via LADD Scleroderma-induced Microstomia

Start date: March 1, 2024
Phase: Early Phase 1
Study type: Interventional

Two treatment methods, ablative carbon dioxide (CO2) laser and intradermal hyaluronidase, will be combined to maximize the beneficial potential of each. Laser-assisted drug delivery (LADD) has been shown to be effective for the administration of medications in diverse skin diseases but not previously reported for the treatment of scleroderma-induced microstomia. By using this laser technique, the investigator can reduce the pain of typical hyaluronidase injections and reap the therapeutic benefit of the laser treatment itself. The investigator's goal is to create greater mouth mobility for chewing and speaking as well as improved oral hygiene, self-esteem, and overall quality of life. Each participant will undergo three separate laser sessions at 4 to 8-week intervals. Participants will also complete a follow-up visit three months after the last laser session to evaluate the response.

NCT ID: NCT05989763 Recruiting - Constipation Clinical Trials

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

TEA in SSc
Start date: February 17, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.

NCT ID: NCT05963048 Completed - Clinical trials for Interstitial Lung Disease

Rituxmab Versus IL-6 in Treating ILD

Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

All SSc patients should know if they have been diagnosed with interstitial lung disease, or pulmonary hypertension and keep results from his/her last pulmonary function test, chest imaging, echocardiogram and stress test

NCT ID: NCT05961267 Recruiting - Clinical trials for Arthritis, Rheumatoid

Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism

MARIGYN
Start date: July 24, 2023
Phase:
Study type: Observational

Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40. Inflammatory rheumatism, such as spondyloarthritis or rheumatoid arthritis, is less prevalent in women, but also affects young people, and is particularly common. Several disease-modifying treatments exist, depending on the severity and evolutivitý of the disease. Some are contraindicated or not recommended during pregnancy and therefore require supervision of pregnancy plans. In addition, some treatments have an immunosuppressive activitý, which implies an annual screening of cervical lesions by cervico-uterine smear. In this context, an adapted gynecological follow-up seems indispensable. The rheumatologist and the internist physician have a crucial role in advising and referring patients to their gynecological colleagues. Studying the qualitý of this gynecological follow-up in a cohort of patients with autoimmune disease or inflammatory rheumatism is of major interest.

NCT ID: NCT05960058 Not yet recruiting - Systemic Sclerosis Clinical Trials

Acceptance and Effectiveness of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) Vaccination in Systemic Sclerosis Patients Treated by Autologous Hematopoietic Stem Cell Transplantation

COV2-VACCinSSc
Start date: July 2023
Phase:
Study type: Observational

On December 27th 2020, the implementation of SARS-CoV-2 vaccination in France first became available amongst all immunosuppressed patients at very high risk of severe Coronavirus Disease (COVID-19) infection, specifically for Hematopoietic Stem Cell Transplant recipients or other fragile immunosuppressed patients. Systemic sclerosis (SSc) is an autoimmune disease characterized by dysregulation of the immune system, vascular damage and progressive fibrosis of the skin and internal organs (heart, lung and kidney) which may lead to severe comorbidities and SSc-related mortality. In severe rapidly progressive SSc, we and others demonstrated that autologous hematopoietic stem cell transplantation (AHSCT) is the only treatment so far allowing improvement in overall and event free survival up to 7 years after AHSCT. As soon as vaccines were available on January 1st, 2021 and following the French Haute Autorité de Santé (HAS) and Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) good clinical practices (GCP) guidelines, the ad hoc COVID19 vaccinations were proposed to all SSc patients in France, including those previously treated by AHSCT and followed at Maladies Auto Immunes et Thérapie Cellulaire (MATHEC) Center of Reference for stem cell therapy at St-Louis hospital. In July 2021, the Autoimmune Diseases Working Party (ADWP) and the European society for Blood and Marrow Transplantation (EBMT) guidelines recommended vaccination against SARS-CoV2 as early as 3 months after HSCT for autoimmune diseases. Only one Israeli study so far has analyzed the efficacy of SARS-CoV-2 vaccination after autologous HSCT (AHSCT) in SSc patients.. We therefore designed the present case control study retrospective study to assess the acceptance and effectiveness of this vaccination program in SSc patients treated by AHSCT as compared to other fragile SSc individuals. The Primary objective is to evaluate the effectiveness of implementing the anti-SARS-CoV2 vaccination program according to the French GCP for COVID-19 prophylaxis in SSc fragile patients, in terms of risk of asymptomatic or symptomatic COVID-19 infection, among SSc patients treated by AHSCT compared to 1:1 matched non transplant SSc controls.