An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent...
DermatomyositisThe purpose of this research study is to evaluate the long-term safety, and tolerability of PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying study.
High-intensity Strength Training in Myositis
MyositisDermatomyositis2 moreThis study evaluates the effects of a high-intensity strength training in patients with myositis with the primary outcome being quality of life (SF-36). The study is designed as a parallel group randomised controlled trial with an intervention group and a control group.
Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis...
DermatomyositisIdiopathic Inflammatory MyopathiesBackground: Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers want to learn more about calcinosis to find treatments for it. Objective: To test if sodium thiosulfate (STS) can treat people with DM with calcinosis. Eligibility: People ages 7 and older who have moderate or severe calcinosis. They must have stable DM and calcium deposits in the torso or at least 2 limbs. Design: Participants will be screened with: Medical history Physical exam Muscle strength and function tests Blood and urine tests Participants will have several visits: 7-day pre-treatment visit about 10 weeks before starting STS Treatment visits over 10 weeks. They will get STS 3 times a week through IV infusion. They may be hospitalized the whole time. If they tolerate the drug, they may be discharged at certain times. During these times, they will return for the infusions. 3- to 5-day post-treatment visits 24 weeks and 62 weeks after starting STS. Visits may include repeats of screening tests and: Questionnaires Scans: They lie in a machine that takes pictures of the body. They may be injected with a radioactive agent. Durometry: A small instrument applies pressure on the skin or exposed calcinosis. Measurements of blood flow in the arms and fingernail blood vessels Photographs of the skin Kidney ultrasound Tests of kidney function Calcinosis aspiration: A needle placed into areas of calcinosis removes liquid.
Exercise Capacity of Patients With Dermatomyosis
DermatomyositisDermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains unknown. The investigators hypothesize that mitochondria functioning is impaired in DM muscle and links with exercise capacities.
Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM)
PolymyositisDermatomyositisThis study will investigate Umbilical Cord Lining Stem Cells (ULSC) as an investigational medicinal product and its use in patients with polymyositis (PM) or dermatomyositis (DM) to see if a single intravenous (IV) infusion of allogeneic umbilical cord lining stem cells (ULSC) safe, tolerable, and feasible to administer.
Exercise, Creatine and Coenzyme Q10 for Childhood Myositis
MyositisJuvenileChildren with JDM are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about their lives compared to children without the disease. There are two nutritional supplements that help muscles use energy and recover after exercise: creatine and coenzyme Q10. If the muscle has more energy, it may not be as weak and may not feel as tired or sore after exercise. Because of this we want to see if having children with JDM take creatine and coenzyme Q10 can make them stronger and less tired. If this works, we hope it will let them be able to do the things that healthy children can do, and make them feel better about their lives.
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
Rheumatoid Arthritis (RA)Systemic Lupus Erythematosus (SLE)7 moreThis is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications. All study participants will have negative serologic or suboptimal responses (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result ≤200 U/mL) or a low immune response (defined as a Roche Elecsys® Anti-SARS-CoV-2 S result >200 U/ml and ≤2500 U/mL) to their previous doses of COVID-19 vaccine. The study will focus on 5 autoimmune diseases in adults: Systemic Lupus Erythematosus (SLE) Rheumatoid Arthritis (RA) Multiple Sclerosis (MS) Systemic Sclerosis (SSc), and Pemphigus. This study will focus on 4 autoimmune diseases in pediatric participants: Systemic Lupus Erythematosus (SLE) Juvenile Idiopathic Arthritis (JIA) Pediatric-Onset Multiple Sclerosis (POMS) Juvenile Dermatomyositis (JDM)
Lenalidomide in the Treatment of Refractory Cutaneous Dermatomyositis
DermatomyositisThe goal of this study is to evaluate the efficacy and safety of lenalidomide in the treatment of patients with active cutaneous DM.
Safety and Preliminary Clinical Activity of Itolizumab in Dermatomyositis
DermatomyositisAdult TypeTo evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of Itolizumab in subjects with Dermatomyositis.
Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity...
DermatomyositisThe Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), established in 2008, is a one-site database study conducted at the University of Pennsylvania. The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. The CDASI database incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis. The CDASI database has led to publication of comparison studies of CDASI and other clinical instruments and the effect of dermatomyositis on Quality of Life (QoL). The CDASI database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. Data will be analysed over a 5 years.