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Scleroderma, Systemic clinical trials

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NCT ID: NCT05215431 Active, not recruiting - Periodontitis Clinical Trials

Antioxidant Profile in Patients With Systemic Sclerosis and Periodontitis

Start date: February 5, 2019
Phase:
Study type: Observational

The aim of the research will be to compare periodontal status and level of antioxidants in unstimulated saliva of systemic sclerosis patients with periodontitis and systemically healthy periodontitis patients. Twenty systemic sclerosis patients with periodontitis (SS group) and twenty systemically healthy periodontitis patients (P group) will be enrolled in the present study. The results may indicate higher periodontal destruction and antioxidant perturbations in unstimulated saliva of systemic sclerosis patients with periodontitis compared to systemically healthy periodontitis patients.

NCT ID: NCT05214794 Active, not recruiting - Systemic Sclerosis Clinical Trials

An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

Start date: April 20, 2022
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.

NCT ID: NCT05214014 Enrolling by invitation - Systemic Sclerosis Clinical Trials

Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells

Start date: September 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Treatment of patients with systemic sclerosis with autologous regulatory Т-cells

NCT ID: NCT05204784 Recruiting - Systemic Sclerosis Clinical Trials

Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

RHEACT
Start date: February 28, 2022
Phase: N/A
Study type: Interventional

In this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with some success in observational studies, nevertheless, the optimal treatment modality, duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of yet.

NCT ID: NCT05204355 Recruiting - Scleroderma Clinical Trials

MRI for Screening and Monitoring Scleroderma ILD

Start date: May 1, 2022
Phase:
Study type: Observational

The purpose of this study is to test MRI methods for evaluating patients with Scleroderma-associated interstitial lung disease.

NCT ID: NCT05198557 Recruiting - Systemic Sclerosis Clinical Trials

A Study of MT-0551 in Patients With Systemic Sclerosis

Start date: July 20, 2022
Phase: Phase 3
Study type: Interventional

The study will verify the superiority of MT-0551 to placebo at 26 weeks after treatment initiation in systemic sclerosis (SSc) patients using the modified Rodnan Total Skin thickness Score (mRTSS) as a measure of skin thickening. The safety and pharmacokinetics will also be investigated.

NCT ID: NCT05181644 Terminated - Scleroderma Clinical Trials

Effectiveness of the EmoLED Medical Device in the Healing of Digital Ulcers in Patients With Scleroderma.

SUITABLE
Start date: April 22, 2022
Phase: N/A
Study type: Interventional

The present clinical study aims to compare, in the two groups of patients with acral ulcers, the reparative process of the injured area, the evaluation of the healing time (with "healing" interpreted as the complete re-epithelization of the wound) and the perception of pain through NRS scale.

NCT ID: NCT05177471 Recruiting - Systemic Sclerosis Clinical Trials

Efficacy and Safety of JAK Inhibitors in Systemic Sclerosis-associated Interstitial Lung Disease

SCLEROJAKI
Start date: January 19, 2022
Phase:
Study type: Observational

Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality. Janus kinases (JAK) inhibitors are recent therapies in the field of systemic autoimmune diseases, already approved in patients with rheumatoid arthritis. Use of JAK inhibitors in systemic sclerosis is based on their anti-inflammatory and anti-fibrotic properties. Several preclinical murine models of systemic sclerosis demonstrated the efficacy of ruxolitinib and tofacitinib on cutaneous and pulmonary fibrosis. Recently, tofacitinib was evaluated in SSc patients in two clinical studies and showed significant improvement on skin fibrosis. The objective of this study is to evaluate efficacy and safety of JAK inhibitors in SSc patients with ILD.

NCT ID: NCT05177380 Not yet recruiting - Rehabilitation Clinical Trials

Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis

PREVISS
Start date: September 2022
Phase: N/A
Study type: Interventional

Systemic sclerosis is a rare autoimmune disorder characterized by microangiopathy, activation of the immune system, and sclerosis of tissues including the skin. Facial involvement is frequent and disabling. It causes significant functional and aesthetic discomfort, and a major deterioration in quality of life. It results in a loss of suppleness of the skin and subcutaneous tissues, dysfunction of the temporomandibular joint, peribuccal rhagades, microstomia, and dry mouth causing difficulties in mouth opening, feeding, dental care, and weight loss. Facial involvement in systemic sclerosis can be assessed using the Mouth Handicap in Systemic Sclerosis (MHISS) score, a validated patient questionnaire assessing the functional and aesthetic consequences of systemic sclerosis on the face. Although common and disabling, facial involvement is underestimated and poorly managed. Immunosuppressive and/or anti-fibrosis drugs are not very effective. Facial rehabilitation could significantly improve the mouth handicap but facial rehabilitation is not currently performed in standard care in systemic sclerosis patients. The aim of the study is to evaluate the efficacy of a personalized rehabilitation program vs standard care in facial involvement of systemic sclerosis patients.

NCT ID: NCT05171114 Completed - Clinical trials for Scleroderma, Systemic

Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

SCLERO-HAND
Start date: December 28, 2021
Phase: N/A
Study type: Interventional

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.