Active clinical trials for "Scleroderma, Diffuse"

systemic sclerosis women usually report problems such as stress/depression, fatigue, not deep sleep. complementary therapies may improve the reported problems in those patients

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.

Primary Objectives: The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life. The aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.

150 patients of legal age will participate in this project, diagnosed with systemic sclerosis. Patients will be randomly assigned, as will be detailed later, to one of the following three groups: Therapy Group (GT): This group will be made up of 50 patients who will receive cognitive behavioral therapy of coping with stress (online modality) in groups of 10-12 people during twelve sessions Consecutive weekly courses of 1.5 to 2 hours duration taught by psychology professionals. of this mode 4 subgroups will be made. Psychological Support Group (AP): This group will be made up of 50 patients who will receive psychoeducation about stress and its consequences and the specific stress suffered by people with a autoimmune disease such as scleroderma. It will have a duration of twelve weekly sessions. Consecutive sessions of 1.5 to 2 hours in length taught by professional psychologists. In this way they will 4 subgroups. Usual Care Group (CG): This group will be made up of 50 patients who will follow their usual care. Later, once the study is over, they will be offered to participate in coping with stress to the person who is interested.

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

The purpose of this study is to assess the degree of improvement seen patient reported outcomes after 30 sessions of UVA-1 therapy in treating systemic scleroderma, morphea, and sclerodermatous Graft-Versus-Host Disease. While patients have verbally reported improvement of their sclerosing skin disease with UVA-1, patient reported outcomes have not been rigorously studied. In sclerosing skin diseases where clinical change is difficult to measure, patient reported outcomes may offer a better way to study the impact of treatments like UVA-1. This will be a non-blinded, non-randomized prospective trial using UVA-1 phototherapy in patients with established sclerosing skin disease. Patients will report the severity of their condition using multiple patient reported outcomes and will also be analyzed using multiple clinical investigator assessments at the beginning and end of 30 treatment sessions.

Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently imprecise and subjective methods that varies amongst different doctors for the same patient are available to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients. This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients.

The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma (systemic sclerosis; SSc) from Canada, the United States, Mexico, Australia, France, Spain, and the United Kingdom. The objectives of SPIN are (1) to assemble a large cohort of SSc patients who complete outcome assessments regularly in order to learn more about important problems faced by people living with SSc and (2) to develop and test a series of internet-based interventions to help patients manage problems related to SSc, including a self-management program (SPIN-SELF Program). The SPIN-SELF Program was designed by SPIN members based on key tenets of behaviour change that have been successfully incorporated in programs for more common diseases and on patient input. It utilizes social modelling through educational videos of SSc patients describing their challenges and what they have done to cope with SSc, as well as videos teaching key self-management techniques. After an introduction to self-management and instructions on how to navigate the program, patients will have access to modules that are most relevant to their symptoms and disease management challenges. The program's modules address (1) pain; (2) skin care, finger ulcers, and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal symptoms; (6) itch; (7) emotions and stress; (8) body image concerns due to disfigurement; and (9) effective communication with healthcare providers. The proposed study is a feasibility trial with progression to full-scale randomized controlled trial (RCT), depending on whether stoppage criteria are met, of the SPIN Self-Management Program. The SPIN-SELF Program was previously feasibility tested as an online only, self-help intervention. However, uptake was low, thus the investigators have moved to a group-based format. SPIN-SELF participants randomized to intervention will access and use online self-management material, and this will be supported by videoconference group sessions, led by trained peer facilitators. In the SPIN-SELF feasibility trial with progression to full-scale trial, the investigators will evaluate the disease management self-efficacy of participants who use SPIN-SELF compared to usual care. Eligible SPIN Cohort participants and externally recruited participants, with low disease-management self-efficacy, will be randomized to the SPIN-SELF Program or to usual care only. In the feasibility portion, 40 eligible participants will be randomized. Unless the trial team determines, based on stoppage criteria, that trial procedures need important modifications thereby re-setting the full scale trial as a new trial, the outcome data of the participants in the feasibility portion will be utilized in the analyses of the full-scale trial. In the full-scale RCT, 524 participants will be randomized.

The purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (SSc).