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Myositis clinical trials

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NCT ID: NCT06154252 Recruiting - Dermatomyositis Clinical Trials

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy

Start date: December 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy

NCT ID: NCT06153108 Recruiting - Clinical trials for Inclusion Body Myositis

Monitoring Biomarker for Detecting Change in Physical Activity and Limb Function in Inclusion Body Myositis Over Time

Start date: November 16, 2023
Phase:
Study type: Observational

Inclusion-Body Myositis (IBM) results in weakness and the deterioration of distal arm muscles, the symptoms of which are currently assessed through expert examination at clinical visits. Such in-clinic assessments are time-consuming, subjective, of limited sensitivity, and only provide a snapshot of a patient's disease. In this project, we will conduct clinical validation of monitoring digital biomarkers of upper limb function during activities of daily living using a wearable sensor platform that enables frequent, at-home monitoring of upper limb function health in IBM and could be incorporated into IBM trials.

NCT ID: NCT06152172 Not yet recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

CARTIMMUNE
Start date: June 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.

NCT ID: NCT06133751 Completed - Clinical trials for Permeability; Increased

Effect of 8-week Supplementation With Black Chokeberry on Recovery in Highly Trained Rowers

Start date: April 1, 2023
Phase: Phase 4
Study type: Interventional

Purpose: To analyze the effects of 8-week supplementation with anthocyanin compounds contained in black chokeberry (Aronia melanocarpa) on indicators of inflammation and oxidative stress. Hypothesis: Supplementation with anti-inflammatory and antioxidant anthocyanin compounds improves recovery from intense exercise by reducing inflammation and oxidative stress in highly trained rowers The study consisted of a nutritional intervention (supplementation) - with compounds of natural origin - chokeberry extract (capsules) - 18% standardized for anthocyanin content (dose 3 x 200 mg per day) - that is, 107 mg of pure anthocyanins per day, or a placebo product that was made from chokeberry fiber Study plan I term of the study 1. Conduct a body composition analysis, body height, food diary, self reported gastrointestinal scale 2. Collection of blood samples before the exercise test for biochemical determinations. 3. Exercise test of 2000m on a rowing ergometer. 4. Collection of blood immediately after exercise and 1 hours after 5. Collection of blood for biochemical determinations 24 hours after the end of the exercise test 6. Supplementation for 8 weeks 2nd test date Repeat the measurements from the 1st test date. Participants: Youth National Rowing Team of Poland Experimental procedure: Observation of the effect of black chokeberry consumption on parameters of inflammation, oxidative stress and intestinal parameters during the immediate start preparation period in highly skilled rowers.

NCT ID: NCT06029335 Active, not recruiting - Healthy Clinical Trials

Clinical Risk Assessment of Cognitive Function in Systemic Autoimmune Diseases

Start date: September 1, 2020
Phase:
Study type: Observational

Objectives: Systemic autoimmune diseases are chronic diseases characterized by chronic inflammation, vasculopathy, and autoimmune phenomena. Several organ involvements are typical, including the central nervous system. Formerly published investigations emphasize a mild cognitive impairment affecting attention, memory, and complicated solution tasks. However, these symptoms significantly impact patients' routines and quality of life. The study examined the associations between cognitive impairment and clinical parameters regarding systemic autoimmune diseases. Methods: General clinical data, some serum biomarkers including CCl-18, YKL-40, COMP, VEGF, Galectin-3, and Pentraxin as well as results of functional, quality of life, and neuropsychological measures, the Mini-Mental State Examination (MMSE), the Digit Span Forward-Backward, the Trail making A, B and the Digit Symbol tests all were administered.

NCT ID: NCT05989399 Not yet recruiting - Clinical trials for Antisynthetase Syndrome

Evaluation of Circulating Neutrophils in Antisynthetase Syndrome

NEUTROSAS2
Start date: January 1, 2024
Phase:
Study type: Observational

Antisynthetase syndrome (ASyS) is a rare and heteregeneous overlapping connective tissue disease, characterized by myositis, interstitial lung disease (ILD), joint involvement, Raynaud's phenomenon and cutaneous manifestations ("mechanic's hands"). Over 50% of patients develop ILD, which is the leading cause of death. The role of neutrophils - innate immune cells involved in inflammatory processes and induced in particular by cytokines of the Th17 pathway - during AS is unknown. Direct pathogenic role of neutrophils has been described during idiopathic inflammatory myopathies, with an increase of netosis correlated with disease activity and muscle damage. During ASyS, a higher number of alveolar neutrophils has been observed in patients with rapidly progressive ILD. There are few data on the specific evaluation of circulating neutrophils in ASyS. Investigators suppose that circulating neutrophils level could represent a simple and accessible severity biomarker in patients with ASyS. The main objective is to evaluate the diagnostic performance of the circulating neutrophils level (> 7000/mm3) at diagnosis on ASyS severity. The secondary objectives are: - to define a threshold for circulating neutrophils levels at diagnosis allowing to predict ASyS severity and to assess the diagnostic performance of this threshold. - to study the correlation between the level of circulating neutrophils and ASyS severity at diagnosis of the disease. - to compare the circulating neutrophils level at ASyS diagnosis and after 1 year of treatment. - to compare patients characteristics according to ASyS severity at diagnosis. - to compare BAL fluid neutrophils level according to ILD severity at ASyS diagnosis in patients with ILD.

NCT ID: NCT05984394 Not yet recruiting - Clinical trials for Antisynthetase Syndrome

Evaluation of Antigen-specific T Cells in Patients With Antisynthetase Syndrome and Interstitial Lung Disease

CYTILDASS
Start date: October 31, 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. Intesrtitial lung disease (ILD) is a leading cause of mortality in antisynthetase syndrome. Recently, antigen-specific IFN-γ+ CD4+ T cells have been identified in bronchoalveolar fluid (BAL) of patients with antisynthetase syndrome and ILD. Elevated levels of IL1β, IL12, IL18, TNFα, IL17A, IL22 have also been detected in peripheral blood of AS patients, especially those with progressive ILD. Implication of innate lymphoid cells (ILC) and mucosal-associated invariant T cells (MAIT) have not yet been studied in patients with AS. Targeted therapies against Th1 and Th17 cells may represent a promising treatment in patients AS patients with ILD. Investigators suppose that antigen-specific Th1 and Th17 cells, ILC and MAIT at ILD diagnosis are associated with ILD severity at diagnosis and could predict treatment response at 6 months. The main objective is to study the correlation between BAL antigen-specific Th1 and Th17 cells at ILD diagnosis and clinical evolution after 6 months of treatment according to initial ILD severity.

NCT ID: NCT05982041 Not yet recruiting - Cardiac Disease Clinical Trials

Adult Idiopathic Inflammatory Myopathy With Cardiac Injury

Start date: January 1, 2024
Phase:
Study type: Observational [Patient Registry]

Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be collected for research purposes to measure a number of biomarkers for the assessment of diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR) muscle protocol will also be performed as per usual clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6-12 months. An existing electronic database entry system will be used for data entry and capture on an anonymised basis.

NCT ID: NCT05979441 Recruiting - Dermatomyositis Clinical Trials

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

ALKIVIA+
Start date: September 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM who previously participated in ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.

NCT ID: NCT05952531 Recruiting - Myositis Clinical Trials

Characterizing Myositis With 68Ga-FAPI PET/CT

Start date: July 1, 2023
Phase: Early Phase 1
Study type: Interventional

To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis and evaluation of systemic involvement in idiopathic inflammatory myopathies (IIM)/myositis, and compared the results with those of 18F-FDG PET/CT.