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Scleroderma, Diffuse clinical trials

View clinical trials related to Scleroderma, Diffuse.

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NCT ID: NCT06152172 Not yet recruiting - Clinical trials for Idiopathic Inflammatory Myopathies

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

CARTIMMUNE
Start date: June 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.

NCT ID: NCT06149260 Recruiting - Fibrosis Clinical Trials

Subcutaneous Semaglutide in Systemic Scleroderma

Start date: February 29, 2024
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis

NCT ID: NCT06133244 Not yet recruiting - Systemic Sclerosis Clinical Trials

Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)

Start date: January 2024
Phase:
Study type: Observational

Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.

NCT ID: NCT06105073 Recruiting - Clinical trials for Systemic Sclerosis Associated Interstitial Lung Disease

"Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis"

Start date: March 1, 2022
Phase:
Study type: Observational [Patient Registry]

Interstitial Lung Disease associated with Systemic Sclerosis currently represents the main cause of death in this disease, it is also the cause of significant morbidity, which is why pulmonary rehabilitation strategies can be of great benefit in this group of patients. The aim of this study is to determine the effect of a 36-session supervised pulmonary rehabilitation program compared before and after, on oxygen consumption, functionality, and quality of life in Interstitial Lung The main question it aims to answer are: What effect will have with a 36-session supervised pulmonary rehabilitation program, compared before and after, on oxygen consumption, functionality and quality of life in Interstitial Lung Disease associated with Systemic Sclerosis, estimated by Cardiopulmonary Exercise Test, the questionnaire self-administered SySQ (systemic sclerosis functionality questionnaire) and the self-administered questionnaire SF-36. Disease associated with Systemic Sclerosis. Study design: Quasi-experimental, longitudinal, comparative before and after study. Methods: Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Systemic Sclerosis, at the Speciality Hospital of the National Medical Center La raza IMSS (Mexican Institute of Social Security), all those patients who wish to participate in the study will be asked to sign the informed consent letter, subsequently the Goldberg anxiety and depression questionnaire will be applied, as well as the SF-36 questionnaire to evaluate quality of life and SySQ to evaluate functionality, all participants will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test, the Pulmonary Function laboratory of the General Hospital National Medical Center La Raza IMSS . Subsequently, they will be sent to the Pulmonary Rehabilitation service, where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions (12 weeks). After the end of the program, respiratory function tests and tests will be performed again questionnaires, pulmonary function tests and cardiopulmonary exercise test.

NCT ID: NCT06095921 Completed - Systemic Sclerosis Clinical Trials

The Effect of a Self-Management Program on Individuals With Scleroderma

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Introduction: Individuals with systemic sclerosis (SSc) have problems with perceived occupational performance and satisfaction in daily life activities due to many symptoms caused by the disease. Purpose: This study will plan to examine the effect of a self-management program for individuals with SSc on perceived occupational performance and satisfaction. Materials and Methods : Twenty-nine individuals with SSC, 28 females and 1 male will participate in the study. Perceived occupational performance and satisfaction levels before and after the program will evaluate with the Canadian Ocupational Performance Measure (COPM). The training programme will design according to the activities of COPM, the needs of the patients, and the literature. The programme consists of 8 sessions for 8 weeks, 1 day a week for 45 minutes.

NCT ID: NCT06058091 Recruiting - Systemic Sclerosis Clinical Trials

RY_SW01 Cell Injection Therapy in Systemic Sclerosis

Start date: September 22, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.

NCT ID: NCT06056921 Recruiting - Sjogren's Syndrome Clinical Trials

Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease

Start date: August 31, 2023
Phase: Phase 1
Study type: Interventional

This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease

NCT ID: NCT06051773 Not yet recruiting - Systemic Sclerosis Clinical Trials

Evaluation of Muscle Involvement in Systemic Sclerosis

MUSSc
Start date: January 1, 2024
Phase:
Study type: Observational

Muscle involvement is poorly described in patients with systemic sclerosis (SSc) . The prevalence of muscle damage is evaluated at 5-95 % of SSc patients, particularly due to variable definitions depending on the series in the scientific litterature. Muscle clinicobiological and histological presentation an response to immunosuppressive treatments are highly variable. Muscle involvement defined by creatinine kinase (CK) elevation, the presence of electromyography (EMG) abnormalities and/or muscle magnetic resonance imaging (MRI) hyperintensities and/or muscle biopsy inflammation appears to be associated with diffuse SSc, the presence of cardiac damage, and anti-PM-Scl antibodies. The main objective is to describe muscular manifestations associated with SSc. Secondary objectives are: - to compare characteristics between SSc patients with and without muscle involvement - to determine homogeneous groups of SSc patients with muscle involvement

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.