View clinical trials related to Arthritis.
Filter by:The goal of this clinical study is to determine if a single injection of 1 or more dose levels of adeno-associated virus (AAV) gene therapy (GNSC-001) is safe and tolerated compared to placebo in participants with painful osteoarthritis (OA) of the knee.
A randomised controlled trial comparing a recently introduced femoral stem with an established stem for total hip arthroplasty (THA). 60 patients will be randomised into one of the two groups 1. Polarstem uncemented femoral stem (Smith & Nephew) 2. Corail uncemented femoral stem (De Puy) All patients will receive a 32mm cobalt-chromium (CoCr) femoral head and an R3 acetabular cup with a 10 Mrad highly cross-linked polyethylene (XLPE) liner (Smith & Nephew). Radiostereometric analysis (RSA) will be used to measure stem migration. Dual-energy x-ray absorptiometry (DXA) measurements will be used to measure bone mineral density. Clinical outcome will be assessed at different time point to evaluate satisfaction and function. Data from the Norwegian Arthroplasty Register will be used to investigate the risk of revision.
This is a two-stage study of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of various doses of levilimab when administered intravenously and subcutaneously to healthy subjects and subjects with active rheumatoid arthritis resistant to methotrexate monotherapy. Aim of the Stage 1 is to study the tolerability, safety, immunogenicity, and main pharmacokinetic and pharmacodynamic parameters of levilimab after its single subcutaneous or intravenous administration at ascending doses to healthy subjects. Aim of the Stage 2 is to confirm the efficacy and safety of levilimab 648 mg IV Q4W in combination with methotrexate and levilimab 324 mg SC Q2W in combination with methotrexate in subjects with active rheumatoid arthritis, resistant to methotrexate monotherapy.
Cardiovascular performance and overall fitness can be improved by high-intensity aerobic activity, and these benefits may be achievable by persons with rheumatic diseases. The investigators hypothesize that a 12-week high-intensity interval exercise program will provide substantial improvements in cardiovascular function, inflammation and symptoms affecting quality of life.
Flares of immune-mediated inflammatory diseases, as Rheumatoid Arthritis (RA), are a major burden for patients in routine care. They occur unpredictably, adding to the physical and psychological burden of the condition. In this study we will deeply dissect the synovial tissue and peripheral blood signature of RA in sustained remission eligible to treatment discontinuation to better understand the individualized factors determining disease flare once biological treatment is discontinued. We expect that the combined study of synovial tissue, imaging and peripheral blood derived biomarkers, associated with disease flare after treatment discontinuation in RA in remission, will provide a tool for the routine assessment of RA eligible to treatment discontinuation reducing the relapse rate and increasing the optimization of the use of expensive pharmacological treatments only for patients still needing them.
Rheumatoid Arthritis (RA) is a chronic autoimmune disease that affects nearly 1% of the general population worldwide leading to joint inflammation, disability and increate mortality. Several factors are associated with disease activity and treatment outcomes. Among them, overweight/obesity status was demonstrated to be associated with higher risk of RA development and most importantly to different treatment response to biological DMARDs. Moreover, overweight/obese RA patients do show higher degree of synovial inflammation compared to lean RA patients. In this context, adipose tissue accumulation is associated with higher inflammatory burden through the secretion by activated mature adipocytes of adipokines with pro-inflammatory properties on innate and adaptive immune cells. Among them, Leptin is an important adipokine, released by mature adipocytes with multiple activating properties on immune cells as monocytes, macrophages, dendritic cells, T and B lymphocytes acting through the activation of its receptor LEPR via JAK/STAT pathway. In particular, leptin exerts its effects on macrophages populations through the promotion of M1 differentiation with pro-inflammatory phenotype. In our research hypothesis we expect that leptin levels does correlate with immunohistochemical scores of synovial inflammatory cells (CD68+, CD21+, CD20+ and CD3+) and CD31+ synovial vessels. Moreover, we expect that the inhibition of JAK/STAT signal using Tofacitinib may interfere with leptin activation action on resident synovial inflammatory cells expressing LEPR (as CD68+, CD20+ and CD3+) in particular restoring the M1/M2 phenotype ratio within resident macrophages populations. Finally, we expect that the inhibition of JAK/STAT signaling pathway by Tofacitinib will result in a significant reduction of synovitis degree in patients with higher leptin expression due to adipose tissue activation.
Biotherapy present specifics risks that patients must know and learn to manage. A national survey has been carried in this study to evaluate patients safety skills. (wording: " cross study of safety skills of 677 patients treat by biopharmaceuticals for an inflammatory rheumatism). This survey has allowed showcasing patients difficulties in managing their treatment, including for those under subcutaneous biotherapy. More than 60% patients interviewed doesn't know symptoms to bring them to consult and mainly postpone to their injection. The aim of this study is to prove that nursing consultation can allow the patient to become independent in treatment management and thus avoid occurrence of adverse event.
This study is to assess the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis (JIA) patients in routine clinical practice in Korea. JIA patients experience persistent joint pain, swelling and stiffness. This is a prospective observational study. Xeljanz is a JAK inhibitor. It was first approved in 2014 for rheumatoid arthritis patients in Korea. The ministry of Food and Drug Safety in Korea mandates for a drug manufacturer to report the post-marketing surveillance after drug's approval or indication extension. This study is to see the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis patients in routine clinical practice in Korea. This study is seeking patients who: - Are 2 to less than 18 years of age; - Are given Xeljanz for the treatment of JIA. The study sponsor will monitor patients' treatment experience for up to 44 weeks. This will help assess the safety and effects of this study medicine.
The goal of this prospective cohort study is to investigate cardiac comorbidity in a random sample of approximately 1200 patients from a population of outpatients with rheumatoid arthritis and axial spondyloarthritis referred to collectively as inflammatory arthritis (IA). The main questions it aims to answer are: - Using conventional echocardiography, the investigators aim to determine the prevalence of overt and asymptomatic cardiac dysfunction in a large random sample of outpatients with IA. Cardiac dysfunction will be evaluated by echocardiography and cardiac biomarkers (NT-pro-BNP, hs-TNT and hs-CRP). - In patients without known heart disease: Using 2, 5 and 10 year follow-up, the investigators aim to examine if advanced echocardiography can be used to detect early signs of heart disease by investigating the clinical significance of adding deformation measures - alone and in combination with selected biomarkers - to conventional risk factors in the cardiac risk assessment of patients with IA Participants will undergo an echocardiographic examination in combination with a general health assessment including obtainment of cardiac biomarkers and a electrocardiogram. Using advanced echocardiography - Tissue Doppler Imaging, 2- dimensional speckle tracking echocardiography, 3D-echocardiography and 3-dimensional speckle tracking echocardiography - the investigators also aim to compare myocardial deformation parameters of patients with IA to a gender and age matched control group without IA from the Copenhagen City Heart Study.
This double-blind, randomized, placebo-controlled study will assess the safety and pharmacokinetics of ZB002 in healthy participants and in participants with rheumatoid arthritis (RA). The study consists of 2 parts. Part A: Single Ascending Dose (SAD), which will include only healthy volunteers. Part B: Multiple Ascending Dose (MAD), will commence after completion of the SAD study and will include RA participants.