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Myositis clinical trials

View clinical trials related to Myositis.

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NCT ID: NCT05799755 Recruiting - Clinical trials for Myositis Associated Interstitial Lund Disease (MA-ILD)

Myositis Interstitial Lung Disease Nintedanib Trial

MINT
Start date: August 1, 2023
Phase: Phase 4
Study type: Interventional

This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD). Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in thickening, stiffness and scarring of the tissues of the lung. This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices. The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine).

NCT ID: NCT05738824 Recruiting - Clinical trials for Inflammation In Skeletal Muscle

Natural History of Inflammatory Muscle Diseases

Start date: June 1, 2023
Phase:
Study type: Observational

Objective: To collect information and biospecimens (such as blood, muscle, and skin samples) that will be used to research causes and treatments of inflammatory muscle diseases. Eligibility: People aged 12 years and older with suspected or confirmed inflammatory muscle disease. Healthy volunteers aged 18 years and older are also needed. Design: Participants will have at least 1 clinic visit. Each visit will last 4 to 8 hours. Some may return for additional visits. All participants will undergo these procedures (unless they are unable to): - Physical exam, including blood and urine tests. - Magnetic resonance imaging (MRI) scan of the thigh. Participants will lie still on a table with padding around 1 thigh. The table will slide into a tube. The scan will last for approximately 40 minutes. Some procedures are optional: - Muscle biopsy. An area of skin will be numbed. A quarter-inch cut will be made. Several pieces of muscle tissue, about the size of grains of rice, will be removed. - Skin biopsy. An area of skin will be numbed. A piece of skin about a quarter inch in diameter will be removed. - Genetic testing. Some of the samples collected may be used for genetic testing.

NCT ID: NCT05738590 Not yet recruiting - Clinical trials for Inflammatory Muscle Disease

Inflammatory and Degenerative Muscle Disease

Start date: April 1, 2023
Phase:
Study type: Observational

Correlation between clinical , ultrasonographical, neurophysiological and histopathological findings in muscle diseases of different etiologies.

NCT ID: NCT05721573 Active, not recruiting - Clinical trials for Inclusion Body Myositis

A Study to Evaluate the Efficacy and Safety of ABC008 for Inclusion Body Myositis

Start date: February 28, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Efficacy and Safety of ABC008 in the Treatment of Subjects with Inclusion Body Myositis

NCT ID: NCT05692349 Not yet recruiting - Myositis Clinical Trials

Magnetic Resonance Imaging and Ultrasonography in Evaluation of Muscle Diseases

Start date: January 2023
Phase:
Study type: Observational

This study aims to determine the association between the pathological changes detected by ultrasound and those detected in MRI in muscle diseases of different etiologies.

NCT ID: NCT05691725 Completed - Clinical trials for Antisynthetase Syndrome

Evaluation of Peripheral Neutrophils in Antisynthetase Syndrome

NEUTROSAS
Start date: February 1, 2023
Phase:
Study type: Observational

Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. A pathogenic role of neutrophils was described during inflammatory myopathies, with increased netosis correlated with disease activity and muscle damage. Higher number of alveolar neutrophils was observed in patients with rapidly progressive forms of interstitial lung disease. Peripheral neutrophils could represent a simple biomarker of severity and activity in patients with antisynthetase syndrome. The main objective is to compare circulating neutrophils between severe and non severe patients with antisynthetase syndrome. Secondary objectives are: 1) to evaluate correlation between circulating neutrophils and organ-specific severity, 2) to compare circulating neutrophils at time of diagnosis and circulating neutrophils after 6 months of treatment in patients with antisynthetase syndrome.

NCT ID: NCT05669014 Recruiting - Clinical trials for Idiopathic Inflammatory Myositis

A Phase 2 Proof of Concept Study to Evaluate the Efficacy and Safety of Daxdilimab in Participants With Dermatomyositis (DM) or Anti-synthetase Inflammatory Myositis (ASIM)

Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

The primary efficacy objective: To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. The secondary efficacy objectives include: 1. To evaluate the effect of daxdilimab compared with placebo in reducing disease activity at Week 24. 2. To evaluate the effect of daxdilimab compared with placebo on skin symptoms at Week 24. 3. To evaluate the effect of daxdilimab on decreasing the use of corticosteroid at Week 24. Other secondary objectives include: 1. To characterize the pharmacokinetics (PK) and immunogenicity of daxdilimab in participants. 2. To evaluate the safety and tolerability of daxdilimab in participants.

NCT ID: NCT05627089 Withdrawn - Clinical trials for Rheumatoid Arthritis

Rheumatoid Arthritis and Myositis Cohort

Start date: July 1, 2023
Phase:
Study type: Observational

The primary objective of this research is to establish a well characterized clinical and longitudinal cohort for individuals with Rheumatoid Arthritis (RA) and Myositis to create a place to maintain blood, urine, stool specimens, excess tissue from procedures, and clinical data, which may be accessed for future research purposes. Specific research objectives of this cohort include: 1. Observe the response that immunosuppressive medications have on the immune cell population and cytokines in individuals with RA or Myositis. 2. Observe the role that the intestinal microbiome has on the immune cell population and cytokines in individuals with RA or Myositis. 3. Observe the connection between intestinal inflammation has on the immune cell population and cytokines in individuals with RA or Myositis.

NCT ID: NCT05523167 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

ALKIVIA
Start date: October 12, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

NCT ID: NCT05454527 Recruiting - Clinical trials for Inflammatory Myositis

Follow-up of Patients With Inflammatory Myopathies Associated With a Biobank

MASC2
Start date: October 26, 2022
Phase:
Study type: Observational

Myositis are rare diseases for which the development of a cohort associated with a bank of biological samples (biobank) will allow for the conduct of researches to better delineate the underlying pathophysiology and find cures. This prospective cohort of patients with myositis will allow for identification of factors favouring the occurrence of myositis, whether they are constitutional (genetic) or acquired (environmental or drug). Different subgroups of myositis used for prognostication will be identified based on clinico-demographical variables, the nature of the organs involved beyond peripheral muscles (cardiac, diaphragm) and biomarkers abnormalities