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Scleroderma, Systemic clinical trials

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NCT ID: NCT04212247 Completed - Systemic Sclerosis Clinical Trials

Trial on Outpatients With Systemic Sclerosis Treated With Well-Being Therapy or With a Control Therapy

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is a rare and potentially life-threatening autoimmune disorder with a significant impact on health and quality of life. The non-pharmacological interventions address to psychological sequalae currently available are limited and have poor efficacy. Well-Being Therapy (WBT) is a brief psychotherapy which has shown efficacy in decreasing the relapse rates of depression in adults, in generalized anxiety disorder and in cyclothymia. WBT has never been tested in SSc and it might represent a useful complementary therapeutic option to improve SSc patients' well-being. The aim of the present study is to evaluate the psychological status of the SSc patients and to test the efficacy of WBT in a sample of SSc patients if compared to a control condition.

NCT ID: NCT04179292 Completed - Rehabilitation Clinical Trials

The Effect of Physiotherapy Program in Scleroderma Patients

Start date: November 21, 2019
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effectiveness of physiotherapy and rehabilitation program on hand involvement of patients with scleroderma and to compare the effects of home rehabilitation program and rehabilitation program under physiotherapist supervision. At the end of the study, the rehabilitation program under the supervision of physiotherapist and home exercise program will be compared with the effects of these applications on range of motion, grip strength, function and sensation. Since there are a limited number of randomized controlled studies in the literature on this subject and there is no randomized controlled clinical study on the superiority of physiotherapist supervision and home program, it will contribute to the information regarding the rehabilitation of scleroderma patients.

NCT ID: NCT04137224 Completed - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)

Start date: September 19, 2019
Phase: Phase 2
Study type: Interventional

This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc). The pharmacokinetic study aims to evaluate the relative bioavailability of IgPro20, and characterize pharmacokinetics of IgPro20 and IgPro10, respectively, in participants with dcSSc. Safety, tolerability, and pharmacokinetics of IgPro10 will also be evaluated.

NCT ID: NCT04118725 Completed - Systemic Sclerosis Clinical Trials

Muscular Respiratory Involvement and Systemic Sclerosis

SIROCO
Start date: October 21, 2019
Phase: N/A
Study type: Interventional

Dyspnea in systemic sclerosis (ScS) constitute a major factor of functional disability. Intensity of dyspnea is sometimes discordant with objectives data from cardiopulmonary involvements, suggesting unknown additional factors. Diffuse fibrosing myopathy of bad prognosis have been reported in ScS.To now, muscular respiratory involvement has not been evaluated in ScS. Therefore, ScS patients (with or without dyspnea) could have underlying respiratory muscular involvement not detected by current standard of care with pulmonary function tests (PFT). This project is the first, to the best of our knowledge, to assess frequency of respiratory muscular involvement in ScS and to evaluate a screening strategy of this involvement.

NCT ID: NCT04066842 Completed - Clinical trials for Vitamin D Deficiency

Vitamin D in Systemic Sclerosis Patients With Periodontitis

Start date: November 1, 2015
Phase:
Study type: Observational

Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.

NCT ID: NCT04045743 Completed - Clinical trials for Scleroderma, Systemic

The Benefit of Bermekimab in Patients With Systemic Sclerosis

Start date: July 19, 2019
Phase: Phase 2
Study type: Interventional

This is a proof-of concept RCT trying to generate evidence that inhibition of IL-1α through the administration of bermekimab may inhibit progression of SSc.

NCT ID: NCT04040322 Completed - Clinical trials for Raynaud's Phenomenon Secondary to Systemic Sclerosis

Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)

Start date: October 14, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with systemic sclerosis.

NCT ID: NCT04001556 Completed - Systemic Sclerosis Clinical Trials

RElevance of UltraSonography for Assessing Salivary Gland Involvement in Systemic Sclerosis (SSc)

REUSSI-SSc
Start date: December 2, 2019
Phase: N/A
Study type: Interventional

As fibrosis of salivary glands is supposed to be the main mechanism involved in Systemic sclerosis (SSc)-associated sicca syndrome, Ultrasonography , biopsy and measuring gland elasticity (by ARFI (Acoustic Radiation Force Impulse)) in SSc patients could also constitute a relevant method to assess the potential alterations of echostructure of major salivary glands and the fibrosis of Salivary Glands in this disease.

NCT ID: NCT03965780 Completed - Clinical trials for Scleroderma, Systemic

The SPIN - Scleroderma Support Group Leader EDucation Program Trial (SPIN-SSLED)

SPIN-SSLED
Start date: September 23, 2019
Phase: N/A
Study type: Interventional

Many people living with scleroderma, a rare autoimmune connective tissue disease, attend support groups to help them cope with the disease. Support groups provide a safe environment where people facing a similar challenge can come together to share disease-related experiences and exchange practical and emotional support. This is especially important for rare diseases such as scleroderma as organized support services can be limited. However, many people with scleroderma do not have access to scleroderma support groups, and many support groups that are initiated are not sustained due to a number of obstacles. Leaders of these support groups play a particularly important role. They are responsible for a wide range of tasks including administrative details that go into planning meetings, facilitating effective and meaningful discussions, managing any issues that may arise in group dynamics, balancing their own needs with the needs of the group and many more. The Scleroderma Patient-centered Intervention Network (SPIN) team has worked with patient organizations and an advisory team of scleroderma support group leaders to develop the Support group Leader EDucation (SPIN-SSLED) Program for scleroderma support group leaders with the goals of (1) providing information and resources to leaders to help them feel more comfortable, confident and supported in their roles and (2) to provide people with the skills they need to establish scleroderma support groups where none exist. The SPIN-SSLED Trial will be used to evaluate the effectiveness of the SPIN-SSLED Program on scleroderma support group leaders' self-efficacy (primary outcome) in carrying out their leader tasks (which is defined as their perceived ability to carry out actions needed to be successful in support group leadership), burnout and emotional well-being.

NCT ID: NCT03941184 Completed - Clinical trials for Rheumatoid Arthritis

Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity

Start date: January 1, 1995
Phase:
Study type: Observational

This case control study aims to determine whether spontaneous coronary artery dissection (SCAD) is associated with autoimmune diseases and to update the incidence of SCAD in a population-based cohort.