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Scleroderma, Diffuse clinical trials

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NCT ID: NCT05149768 Recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.

NCT ID: NCT05148598 Not yet recruiting - Clinical trials for Scleroderma, Diffuse

ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

STAR-II
Start date: February 28, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

NCT ID: NCT05108857 Enrolling by invitation - Systemic Sclerosis Clinical Trials

PET Imaging of Systemic Sclerosis Using FDG and 68Ga-DOTA-Siglec-9 9

SYSPET
Start date: November 29, 2021
Phase:
Study type: Observational

This study evaluates the potential of positron emission tomography (PET)/computed tomography (CT) imaging to monitor disease activity in patients with systemic sclerosis (SSc). PET/CT imaging will focus on two pathological features of SSc, i.e. metabolic activity evaluated by glucose analog 18F-FDG, and expression of inflammation-inducible vascular adhesion protein 1 (VAP-1) evaluated by 68Ga-DOTA-Siglec-9 tracer.

NCT ID: NCT05105217 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Evaluation of Slit2 in Systemic Lupus Erythematosus and Systemic Sclerosis Patients

Start date: December 1, 2021
Phase:
Study type: Observational

1.Assessment of slit2 level in SLE patients and its correlation with disease activity. 2-Assessment of slit2 level in SSC patients and its correlation with disease activity

NCT ID: NCT05103553 Not yet recruiting - Systemic Sclerosis Clinical Trials

What is the Optimal Follow-up for Patients With Systemic Sclerosis?

PRASSc
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a complex multisystem rheumatic autoimmune disease. Currently, evidence based guidelines for frequency and intensity of follow-up of SSc patients are not available. Based on expert consensus annual extensive evaluation is recommended. To provide comprehensive multidisciplinary care integrated with evaluation of organ involvement and as such, reducing health care utilization while improving the quality of care for the patient, the "Leiden Combined Care in SSc (CCISS) pathway" was started in 2009. Data collected on disease progression in the patients that participate in this care pathway show that 50% of the patients have relatively mild disease, without any disease progression over time. Therefore there is a need for tailor made care in SSc patients in accordance to disease activity. To enable this, a prediction model was developed that can identify patients with low risk for disease progression.

NCT ID: NCT05098704 Recruiting - Systemic Sclerosis Clinical Trials

Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk

PSSIT
Start date: June 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. The association of Raynaud phenomenon and SSc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. The aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.

NCT ID: NCT05098145 Withdrawn - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis

FREEDOM-3
Start date: November 24, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) at risk for organ failure.

NCT ID: NCT05085444 Recruiting - Autoimmune Diseases Clinical Trials

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

Start date: October 8, 2021
Phase: Early Phase 1
Study type: Interventional

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma

NCT ID: NCT05080738 Completed - Scleroderma Clinical Trials

Upper Extremity Home Exercises in Patients With Scleroderma

Start date: September 10, 2021
Phase: N/A
Study type: Interventional

Hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. The vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. Literature indicate that more work is needed to continue to develop and evaluate rehabilitation interventions in this population. This study is a randomized controlled study examining the effects of 8 weeks of upper extremity home exercises on grip strength, normal joint movement, activity performance and functionality in patients with scleroderma. In our study, it is aimed to contribute to the standardization of upper extremity exercise protocols for scleroderma patients, to increase the quality of life of patients and to increase their independence in daily living activities.

NCT ID: NCT05078749 Recruiting - Systemic Sclerosis Clinical Trials

The Effects of Telerehabilitation Based Exercise Program in Patients With Systemic Sclerosis

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the musculoskeletal, cardiac, pulmonary, and gastrointestinal systems. Patients may experience many symptoms such as pain, fatigue, dyspnea, impaired hand function, dry mouth, and difficulty sleeping. As a result of these symptoms, these patients may experience a decrease in activities of daily living, physical activity level and quality of life, while psychological problems such as anxiety and depression may increase. In addition to medical treatment, rehabilitation programs for the patient are an important part of treatment to eliminate or reduce these symptoms and their consequences. Many problems such as time and resource constraints, transportation problems prevent access and compliance with the rehabilitation program. Also; For the coronavirus disease 2019 (COVID-19) epidemic that emerged in Wuhan, China in 2019, many countries have implemented many practices such as social distance, mandatory quarantine and transportation restrictions in order to better control the spread of the virus. Many people with SSc are at risk of serious complications from COVID-19 if infected due to lung involvement (>40% have interstitial lung disease) and widespread use of immunosuppressant drugs. Most countries have recommended that people with medical conditions such as SSc undergo strict isolation during the COVID-19 pandemic. As a result, patients' access to the rehabilitation program became more difficult in this process. In addition, social isolation due to the COVID-19 outbreak may increase physical inactivity and cause complications that may develop accordingly. When the literature was examined, no studies were found showing the effect of telerehabilitation program on anxiety depression, physical activity, sleep, fatigue and quality of life in patients with SSc.