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Scleroderma clinical trials

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NCT ID: NCT04837131 Terminated - Systemic Sclerosis Clinical Trials

A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients

Start date: April 28, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to learn about the effects of the medication ixazomib in participants with scleroderma/systemic sclerosis including its safety and tolerability, its effects on skin, lungs and other organs, and its effects on overall health and quality of life.

NCT ID: NCT04178616 Terminated - Scleroderma Clinical Trials

Assessment of the Prevalence of Olfactory Disorders in Systemic Scleroderma

SCLEROLF
Start date: December 31, 2019
Phase: N/A
Study type: Interventional

Prospective monocentric study of patients with systemic sclerosis disease. The primary outcome is to define the prevalence of olfactory disorders (hyposmia and anosmia) in systemic sclerosis disease. The secondary outcomes are: - To assess the correlation of olfaction disorders with clinical and biological and factors related to systemic sclerosis patients. - To estimate the frequency of sinonasal disorders in patients with systemic sclerosis disease

NCT ID: NCT03937856 Terminated - Clinical trials for Systemic Lupus Erythematosus

Smartphone Mindfulness Meditation for Patients With Rheumatic Diseases

Start date: May 7, 2019
Phase: N/A
Study type: Interventional

This study will assess the effect of a mindfulness meditation program administered via a smartphone application on health-related quality of life for patients with rheumatic disease.

NCT ID: NCT03740724 Terminated - Scleroderma Clinical Trials

A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)

Start date: December 18, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A two-component therapeutic consisting of FCX-013 and veledimex for the treatment of localized scleroderma (or morphea). The first component, FCX-013, is autologous human fibroblasts genetically-modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1), a protein responsible for breaking down collagen. FCX-013 is designed to be injected under the skin at the location of the fibrotic lesions where the genetically-modified fibroblast cells will produce MMP-1 to break down excess collagen accumulation. With the FCX-013 therapy, the patient will take an oral compound (Veledimex) to induce MMP-1 protein expression from the injected cells. Once the fibrosis is resolved, the patient will stop taking the oral compound which will stop further MMP-1 production from the injected cells. FCX-013 plus veledimex is being developed in anticipation of improving skin function in patients by resolving fibrotic lesions and normalizing dermal collagen production

NCT ID: NCT03593902 Terminated - Systemic Sclerosis Clinical Trials

Cardiac Safe Transplants for Systemic Sclerosis

CAST
Start date: May 17, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study is designed to treat systemic sclerosis (scleroderma) patients with an autologous stem cell transplant using a regimen of immune suppressant drugs and chemotherapy that is less toxic to your heart.

NCT ID: NCT03411057 Terminated - Clinical trials for Rheumatoid Arthritis

Mindfulness Based Stress Reduction in Rheumatic Diseases

MBSR
Start date: January 18, 2018
Phase:
Study type: Observational

This study will assess the mental health and clinical benefits of Mindfulness Based Stress Reduction (MBSR) in patients with rheumatic disease who have anxiety or depression. MBSR, an interactive form of meditation that includes gentle yoga, will be taught by a certified instructor over an eight-week period. Mental health surveys will be conducted within one month of the study start and end as well as mid-course. Clinical assessments will be conducted within one-month of the study start and end.

NCT ID: NCT02851875 Terminated - Systemic Sclerosis Clinical Trials

Duke Scleroderma Clinic Patient Registry

Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of the Duke Scleroderma Registry (DSScR) is to obtain information about scleroderma. This information could be used in future research to increase the understanding of disease mechanisms, treatments, and outcomes. This research may also help develop new therapies, novel measures of disease assessment or identify previously unknown manifestations of the diseases. A prospectively followed cohort is an integral component of future translational and clinical research programs. A registry for scleroderma would allow for information to be gleaned about patients in "real-world situations" in an effort to improve the reality, generalizability and applicability of information gathered.

NCT ID: NCT01545427 Terminated - Scleroderma Clinical Trials

Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma

Start date: April 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of the drug Gleevec (imatinib) as a new treatment for patients with active diffuse scleroderma. This drug has not been used previously to treat scleroderma, but it has been found to advance the treatment and life span of patients with a type of leukemia called chronic myeloid leukemia or CML. Gleevec acts on chemical signals in the cells that may decrease fibrosis (the hardening of the skin that occurs in scleroderma). It works by interfering in the process that activates many molecules that cause fibrosis, including TGFbeta (which may be a key part of disease activity in scleroderma). This study proposes to treat patients that have significant diffuse scleroderma with Gleevec for 6 months and investigate several measures of scleroderma disease activity before, during and at the end of treatment (0, 3 months and 6 months). This is a randomized, double blind, placebo-controlled trial: 20 patients will be divided into two groups in a 4:1 ratio, with 16 patients taking 400mg of Gleevec per day and 4 taking a placebo. The differences between the groups that will be measured include safety, Modified Rodnan skin score (mRSS), Health Assessment Questionnaire (HAQ), global assessments (100mm VAS) and changes in biomarkers in blood and skin biopsies.

NCT ID: NCT00476697 Terminated - Scleroderma Clinical Trials

UVA1 Light for Scleroderma and Similar Conditions

Start date: January 1997
Phase: N/A
Study type: Interventional

The purpose of this investigation is to evaluate the effectiveness of high-dose UVA1 irradiation in the treatment of fibrosing conditions of the skin, e.g., keloid (a thick scar from growth of fibrous tissue), scleroderma (deposits of fibrous tissue in the skin) and acne keloidalis nuchae (keloids on the back of the neck or hairline) old burn scars, granuloma annulare or other similar skin conditions. This UVA1 dosing schedule has been used successfully in Germany for various skin diseases, such as the above mentioned scleroderma.

NCT ID: NCT00282425 Terminated - Scleroderma Clinical Trials

Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis

Start date: May 2005
Phase: Phase 1
Study type: Interventional

Scleroderma is disease believed to be due to immune cells, cells which normally protect the body but are now causing damage to the body. There has not been any treatment that has been effective in treating this disease. The likelihood of progression of the disease to severe disability and death is high. This study is designed to examine whether treating patients with high dose Cyclophosphamide and Fludarabine (drugs which reduce the function of your immune system) and CAMPATH-1H (a protein that kills the immune cells that are thought to be causing the disease), followed by return of blood stem cells that have been previously collected from patients brother or sister will stop or reverse the disease. The purpose of the Cyclophosphamide, Fludarabine and CAMPATH-1H is to decrease immune system. The purpose of the stem cell infusion is to restore blood production, which will be severely impaired by the Cyclophosphamide, Fludarabine and CAMPATH-1H, and to produce a normal immune system that will no longer attack the body.