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Scleroderma, Systemic clinical trials

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NCT ID: NCT06316076 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases

Start date: October 30, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases

NCT ID: NCT06297096 Not yet recruiting - Systemic Sclerosis Clinical Trials

Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease

NINTOC-TU
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.

NCT ID: NCT06291142 Enrolling by invitation - Systemic Sclerosis Clinical Trials

Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot

Start date: November 22, 2023
Phase:
Study type: Observational

The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are: - Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report? - Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report - Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content. Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system. Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report.

NCT ID: NCT06287125 Not yet recruiting - Clinical trials for Systemic Sclerosis and Systemic Lupus Erythematous

Renal Assessment for Early Detection of Renal Impairment in Systemic Sclerosis and Systemic Lupus Erythematosus Patients

Start date: March 1, 2024
Phase:
Study type: Observational

- Evaluate renal resistive index in SSc and SLE patients for early detection of renal impairment. - Evaluate renal multi-parametric MRI in SSc and SLE patients for early detection of renal impairment. - Measure the serum levels of CD147 in SSc and SLE patients and its correlation with renal impairment. - Correlation between detected markers and other assessment tools.

NCT ID: NCT06264492 Not yet recruiting - Scleroderma Clinical Trials

Delving Into Participation Trends of Scleroderma Clinical Trials

Start date: March 2025
Phase:
Study type: Observational

Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics. The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma.

NCT ID: NCT06256575 Not yet recruiting - Clinical trials for Scleroderma, Systemic

Study of Diosmin-Diosmetin for the Treatment of Digital Ulcers in Systemic Sclerosis

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

This study is performed to consider the safety and healing ability of diosmin-diosmetin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). . The study will include 21-45 patients who will randomly be given either active product or inactive product (placebo). Two (2) out of every three (3) patients enrolled will receive active product. The patients will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle. Diosmin-Diosmetin is a naturally occurring compound found in citrus fruits and vegetables known as flavonoids. This product has been used to treat poor blood circulation in a variety of countries.

NCT ID: NCT06231433 Completed - Systemic Sclerosis Clinical Trials

Effects of Fractional CO2 Laser Treatment on Vaginal Symptoms and Sexual Dysfunction in Women With Systemic Sclerosis

SCLERDERMCO2
Start date: May 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Women affected by Systemic Sclerosis and Vulvovaginal Atrophy will be submitted to a cycle composed of five vaginal CO2 laser treatment (SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy - Hi Scan V2LR con sonda vaginale a 360 °, dot power 30 watt, dwell time 1000 μs, dot spacing 1000 μm smart stack 1-3, emission mode deka pulse) every 30-40 days. At 1-month follow up from the last vaginal laser treatment (6 months from baseline) vagina and sexual health will be assessed by a 1-5 Likert scale, a 0-10 Visual Analogue Scale for vulvovaginal symptoms and the Female Sexual Function Index.

NCT ID: NCT06210945 Suspended - Systemic Sclerosis Clinical Trials

Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis

ABATE
Start date: September 2024
Phase: Phase 2
Study type: Interventional

This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo.

NCT ID: NCT06195072 Not yet recruiting - Scleroderma Clinical Trials

Platform Clinical Study for Conquering Scleroderma

CONQUEST
Start date: April 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

NCT ID: NCT06189495 Not yet recruiting - Clinical trials for Systemic Sclerosis Associated Interstitial Lung Disease

A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile of Genakumab Injection in Patients With Connective Tissue Disease-associated Interstitial Lung Disease

Start date: December 30, 2023
Phase: Phase 2
Study type: Interventional

This study was conducted in a randomized, double-blind, placebo-controlled design to evaluate the efficacy and safety of Genakumab injection in the treatment of CTD-ILD including Rheumatoid Arthritis associated Interstitial Lung Disease (RA-ILD) and Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)