Popular Trials
Alkylating agents
Stem Cell Transplant for Scleroderma
This trial tests a treatment for systemic scleroderma involving stem cell collection, high-dose chemotherapy, and immune suppression, followed by returning the patient's own stem cells and using a maintenance drug to prevent disease recurrence. The treatment has shown a satisfactory risk-benefit ratio in earlier studies.
Enzyme
Hyaluronidase + CO2 Laser for Small Mouth
This trial explores combining two treatments to improve mouth mobility, hygiene, self-esteem, and quality of life for people with scleroderma-induced microstomia. Laser-assisted drug delivery used to reduce pain of injections. 3 laser sessions at 4-8 week intervals, followed by 3mo follow-up.
Phototherapy
UVA-1 Phototherapy for Scleroderma
This trial will use a single-blind, prospective, randomized (dominant/non-dominant hand) comparator design to assess the effect of high dose (80-120 J/cm2) UVA1 therapy on hand function in scleroderma in a paired t-test design. This study will be placebo-controlled (with a UV-blocking gloved hand), cross-over, randomized clinical trial.
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Trials for SSc Patients
Monoclonal Antibodies
Brentuximab Vedotin for Systemic Sclerosis
This trial aims to test the safety and effectiveness of Brentuximab vedotin in patients with a certain type of skin disease called diffuse cutaneous systemic sclerosis who have not responded well to previous treatment
Procedure
Extracorporeal Photopheresis for Systemic Sclerosis
This trial is testing a treatment called Extracorporeal Photopheresis for patients with a severe form of scleroderma. The treatment involves taking blood out, treating it with light and a drug, and then putting it back in. The goal is to see if this can safely reduce skin thickening and improve symptoms. Extracorporeal photopheresis (ECP) has been used for over 30 years, initially for cutaneous T-cell lymphoma and later for other diseases including scleroderma.
Skin involvement for Systemic Sclerosis
Systemic Sclerosis (SSc) is an autoimmune connective tissue disease characterized by autoantibodies, fibrosis and microvascular injury and endothelial cell activation that results in vascular damage. Vascular injury induces both innate and acquired immune responses resulting in fibroblast activation and organ fibrosis. SSc may target multiple organs, including: skin, lungs, heart, vascularization, kidneys, the gastrointestinal tract and musculoskeletal structures. Mortality among scleroderma patients is significant, with a 3.5 standardized mortality ratio (SMR) in studies of prevalent cases. This mortality may be increased in the early years of the disease, reaching a SMR of 4 in a multinational inception cohort. In general, treatment strategies target involved organs as early as possible to avoid damage. Many treatment options are available for each manifestation, but evidence with respect to the order of treatment is scarce. Financial costs, the lack of proper outcome measures, difficulty to recruit patients as a rare disease, all prevent the development of new big clinical trials, oppositely to other common diseases such as stroke or cancer. The heterogeneous features of SSc may make trials challenging. The current guidelines available are the British guidelines (2017) , and the updated European League Against Rheumatism (EULAR) guidelines, published in 2017. Management guidelines have some gaps regarding second-line treatment, combinations and there are no proposed algorithms. With the pragmatic trials, the investigators intend to fill the gap between the complicated randomized clinical trials and the observational studies. Using the treatments that have already been proved useful in SSc, in an open-label randomized way and based on some refined expert-made algorithms, will allow the investigators to establish the order in how to use them. Patients will be offered to participate with the collection of their clinical data and, if they give their consent, they will be randomized according to the algorithms. There will be an optional part of the study consisting in the collection of blood samples and skin samples for future research.
Thromboxane A2 Receptor Antagonist
Oral Ifetroban for Scleroderma
This trial is testing ifetroban, an oral medication, in patients with severe forms of systemic sclerosis. The goal is to see if it can reduce inflammation and improve blood flow, potentially helping to manage their condition better.
Trials for Systemic Sclerosis Patients
Monoclonal Antibodies
Brentuximab Vedotin for Systemic Sclerosis
This trial aims to test the safety and effectiveness of Brentuximab vedotin in patients with a certain type of skin disease called diffuse cutaneous systemic sclerosis who have not responded well to previous treatment
Procedure
Extracorporeal Photopheresis for Systemic Sclerosis
This trial is testing a treatment called Extracorporeal Photopheresis for patients with a severe form of scleroderma. The treatment involves taking blood out, treating it with light and a drug, and then putting it back in. The goal is to see if this can safely reduce skin thickening and improve symptoms. Extracorporeal photopheresis (ECP) has been used for over 30 years, initially for cutaneous T-cell lymphoma and later for other diseases including scleroderma.
Skin involvement for Systemic Sclerosis
Systemic Sclerosis (SSc) is an autoimmune connective tissue disease characterized by autoantibodies, fibrosis and microvascular injury and endothelial cell activation that results in vascular damage. Vascular injury induces both innate and acquired immune responses resulting in fibroblast activation and organ fibrosis. SSc may target multiple organs, including: skin, lungs, heart, vascularization, kidneys, the gastrointestinal tract and musculoskeletal structures. Mortality among scleroderma patients is significant, with a 3.5 standardized mortality ratio (SMR) in studies of prevalent cases. This mortality may be increased in the early years of the disease, reaching a SMR of 4 in a multinational inception cohort. In general, treatment strategies target involved organs as early as possible to avoid damage. Many treatment options are available for each manifestation, but evidence with respect to the order of treatment is scarce. Financial costs, the lack of proper outcome measures, difficulty to recruit patients as a rare disease, all prevent the development of new big clinical trials, oppositely to other common diseases such as stroke or cancer. The heterogeneous features of SSc may make trials challenging. The current guidelines available are the British guidelines (2017) , and the updated European League Against Rheumatism (EULAR) guidelines, published in 2017. Management guidelines have some gaps regarding second-line treatment, combinations and there are no proposed algorithms. With the pragmatic trials, the investigators intend to fill the gap between the complicated randomized clinical trials and the observational studies. Using the treatments that have already been proved useful in SSc, in an open-label randomized way and based on some refined expert-made algorithms, will allow the investigators to establish the order in how to use them. Patients will be offered to participate with the collection of their clinical data and, if they give their consent, they will be randomized according to the algorithms. There will be an optional part of the study consisting in the collection of blood samples and skin samples for future research.
Thromboxane A2 Receptor Antagonist
Oral Ifetroban for Scleroderma
This trial is testing ifetroban, an oral medication, in patients with severe forms of systemic sclerosis. The goal is to see if it can reduce inflammation and improve blood flow, potentially helping to manage their condition better.
Trials With No Placebo
Monoclonal Antibodies
Brentuximab Vedotin for Systemic Sclerosis
This trial aims to test the safety and effectiveness of Brentuximab vedotin in patients with a certain type of skin disease called diffuse cutaneous systemic sclerosis who have not responded well to previous treatment
Procedure
Extracorporeal Photopheresis for Systemic Sclerosis
This trial is testing a treatment called Extracorporeal Photopheresis for patients with a severe form of scleroderma. The treatment involves taking blood out, treating it with light and a drug, and then putting it back in. The goal is to see if this can safely reduce skin thickening and improve symptoms. Extracorporeal photopheresis (ECP) has been used for over 30 years, initially for cutaneous T-cell lymphoma and later for other diseases including scleroderma.
Endothelin Receptor Antagonist
Macitentan for Interstitial Lung Disease
This trial is testing Macitentan, a drug that helps relax and widen blood vessels, on patients with interstitial lung disease (ILD) and scleroderma who also have pulmonary hypertension (PH). These patients often do not respond well to existing treatments. The goal is to see if Macitentan can improve heart function, exercise capacity, and symptoms in these patients. Macitentan is a novel, dual endothelin receptor antagonist recently approved for the treatment of WHO Group I pulmonary arterial hypertension.
Skin involvement for Systemic Sclerosis
Systemic Sclerosis (SSc) is an autoimmune connective tissue disease characterized by autoantibodies, fibrosis and microvascular injury and endothelial cell activation that results in vascular damage. Vascular injury induces both innate and acquired immune responses resulting in fibroblast activation and organ fibrosis. SSc may target multiple organs, including: skin, lungs, heart, vascularization, kidneys, the gastrointestinal tract and musculoskeletal structures. Mortality among scleroderma patients is significant, with a 3.5 standardized mortality ratio (SMR) in studies of prevalent cases. This mortality may be increased in the early years of the disease, reaching a SMR of 4 in a multinational inception cohort. In general, treatment strategies target involved organs as early as possible to avoid damage. Many treatment options are available for each manifestation, but evidence with respect to the order of treatment is scarce. Financial costs, the lack of proper outcome measures, difficulty to recruit patients as a rare disease, all prevent the development of new big clinical trials, oppositely to other common diseases such as stroke or cancer. The heterogeneous features of SSc may make trials challenging. The current guidelines available are the British guidelines (2017) , and the updated European League Against Rheumatism (EULAR) guidelines, published in 2017. Management guidelines have some gaps regarding second-line treatment, combinations and there are no proposed algorithms. With the pragmatic trials, the investigators intend to fill the gap between the complicated randomized clinical trials and the observational studies. Using the treatments that have already been proved useful in SSc, in an open-label randomized way and based on some refined expert-made algorithms, will allow the investigators to establish the order in how to use them. Patients will be offered to participate with the collection of their clinical data and, if they give their consent, they will be randomized according to the algorithms. There will be an optional part of the study consisting in the collection of blood samples and skin samples for future research.
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Frequently Asked Questions
Introduction to scleroderma
What are the top hospitals conducting scleroderma research?
When it comes to conducting clinical trials for the complex autoimmune disease known as scleroderma, several top hospitals are leading the charge. In London, Canada, the Rheumatology Clinic at St. Joseph's Health Care is actively engaged in two ongoing scleroderma trials and has a total of three recorded trials dedicated to this condition. This clinic embarked on their first scleroderma trial in 2018, demonstrating their commitment to advancing knowledge and treatment options for patients suffering from this challenging disease.
Across the Atlantic Ocean in Omaha, Nebraska, two prominent medical centers are making significant contributions. The Lauritzen Outpatient Center at the University of Nebraska Medical Center is currently focused on one active scleroderma trial while having previously conducted one study since recording their inaugural trial in 2023. Simultaneously, Nebraska Medicine's Dermatology Westroads facility also engages in one active scleroderma trial alongside its one historical investigation that commenced during the same year.
In Murray, Utah, the University of Utah MidValley Dermatology plays a crucial role by conducting an ongoing clinical trial for patients with scleroderma. Having initiated their first recorded study in 2020 showcases their dedication towards finding innovative solutions and improving outcomes for individuals affected by this rare condition.
Finally highlighting Mayo Clinic located amidst Arizona’s serene Scottsdale region; they not only contribute significantly to patient care but also engage actively in research endeavors against various diseases including Scleroderma.They presently have an active clinical test aimed towards tackling Sclerodermic conditions along with two previous investigations which occured respectivelyin 2011.These efforts exemplify Mayo Clinic's unwavering commitment towards providing cutting-edge treatments and improving the lives of those living with sclerosis
These leading hospitals serve as beacons of hope within the field of scleroderma research, striving tirelessly to bring about advancements that will ultimately enhance both understanding and management strategies surrounding this enigmatic disease. Each trial undertaken represents a step closer to unraveling the complexities of scleroderma and ultimately providing better outcomes for patients around the world.
Which are the best cities for scleroderma clinical trials?
When it comes to scleroderma clinical trials, several cities emerge as key players in advancing research and treatment options. Boston, Massachusetts leads the way with four active trials focusing on various interventions such as Peripheral Blood Stem Cell Transplantation, Oral Ifetroban, and Scleroderma. London, Ontario follows closely behind with three ongoing studies investigating Extracorporeal Photopheresis (ECP), Brentuximab Vedotin, and Skin involvement. Additionally, Baltimore, Maryland joins the ranks with three active trials exploring treatments like Sildenafil and Anifrolumab (subcutaneous weekly injection). These locations offer individuals diagnosed with scleroderma access to cutting-edge clinical trials that hold promise for improved care outcomes.
Which are the top treatments for scleroderma being explored in clinical trials?
Scleroderma, a challenging autoimmune condition, is currently the focus of several innovative treatments being explored in clinical trials. Extracorporeal Photopheresis (ECP) has caught researchers' attention with its potential benefits and is undergoing one active trial since its recent listing in 2023. Ixazomib, another promising treatment option for scleroderma patients, is also under investigation with one ongoing trial initiated in 2021. Sildenafil, known for its use in other conditions like erectile dysfunction, shows promise as well and has been evaluated in two all-time scleroderma trials since it was first listed back in 2010. These pioneering treatments offer hope to individuals battling this complex disease and may pave the way for improved outcomes and quality of life.
What are the most recent clinical trials for scleroderma?
Exciting advancements in scleroderma research bring hope to those affected by this challenging condition. Recently, a Phase 3 clinical trial introduced anifrolumab—a subcutaneous weekly injection—as a potential treatment for scleroderma. This promising therapy aims to address the underlying mechanisms of the disease and provide relief for patients. Additionally, studies exploring the use of COVID-19 vaccines in individuals with scleroderma have progressed into Phase 2 and Phase 3 trials, highlighting efforts towards protecting this vulnerable population during the pandemic. Another notable investigation examined sildenafil's efficacy in managing scleroderma symptoms through a Phase 2 trial conducted last September. With these groundbreaking initiatives pushing boundaries, there is renewed optimism within the field regarding improved treatment options for individuals living with scleroderma.
What scleroderma clinical trials were recently completed?
Recent advancements in the field of scleroderma have seen the completion of notable clinical trials, bringing hope for improved treatments. In November 2017, Michael Roth sponsored a trial investigating Pirfenidone (PFD) and its potential benefits in managing this complex disease. Additionally, the National Institute of Allergy and Infectious Diseases (NIAID) completed a study involving Brentuximab Vedotin therapy back in September 2017. These significant milestones reflect ongoing efforts to explore innovative approaches towards addressing scleroderma and improving patient outcomes.