View clinical trials related to Gout.
Filter by:To evaluate the safety, tolerability, PK and preliminary PD of SSS11 for injection in chinese healthy adult volunteers.
Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.
SSS11 is pegsiticase consisting of a recombinant uricase conjugated to multiple 20kDa PEG molecules. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose SSS11 administered intravenously in healthy volunteers.
Introduction: The medical treatment of inflammatory rheumatic diseases has improved dramatically during the last decades primarily due to the introduction of biological disease modifying anti-rheumatic drugs (bDMARDs). However, bDMARD treatment failure occurs in 30-40% of patients due to lack of effectiveness or side effects. The tools to predict treatment outcomes in the individual patient are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to 1) diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity, 2) improve prognostication or 3) predict treatment effectiveness and tolerability for the individual patient. Methods and analysis: Observational and translational open cohort study with prospective collection of clinical data and biological materials in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute one cross-sectional blood sample (i.e. whole blood, serum, EDTA-plasma and -buffy coat, and blood in PAXgene RNA tubes) and/or are enrolled for longitudinal follow-up upon start of new DMARD (blood sampling after 0/3/6/12/24/36/48/60 months' treatment). Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (June 2017) >5,000 samples from ≈3,000 patients have been collected. Data will be analysed using appropriate statistical analyses. Ethics and dissemination: The protocol is approved by the Danish Ethics Committee and The Danish Data Protection Agency. All participants give written informed consent. Biomarkers will be evaluated and published according to REMARK, STROBE and STARD guidelines. Results will be published in peer-reviewed medical journals and presented at international conferences.
Rationale: Gout is a disease with growing incidence and complexity due to increased life expectancy, co-morbidity and medication. The disease can be diagnosed by microscopy, demonstrating monosodium uric acid (MSU) in synovial fluid of the affected joint or in tophi (subcutaneous or peritendinous MSU depositions). In daily practice, however, the diagnosis is difficult to ascertain due to sampling error (no synovial fluid acquired because the needle was not exactly placed in the affected joint, or the location of the gout might have been extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g. infection, reactive arthritis). Recently, Dual Energy CT scan has become available. This technique allows the visualization and quantification of MSU. Although imaging modalities such as DECT show promise in the classification of gout, the studies to date have been small and have primarily involved people with established disease. A study with cross-sectional design in which patients for whom the clinical questions "does this patient have gout?" are referred for participation may contribute to assess the value of DECT scan in diagnosing acute arthritis caused by gout. Objective: Assessment of value of DECT scan in diagnosing acute arthritis, caused by gout. Study design: Prospective Study population: Patients with acute mono or oligo arthritis without prior diagnosis, the rheumatologist has an indication for diagnostic needle aspiration. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In current daily practice, patients with acute mono- or oligo-arthritis without prior diagnosis undergo a diagnostic aspiration of the affected joint. This can be done by blind aspiration or ultra sound guided aspiration depending on the judgement of the rheumatologist. The aspirated synovial fluid is then assessed by polarized microscopy to detect MSU crystals. The diagnostic value of DECT in acute gout attacks had not yet been established and is therefore not used in daily practice. In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy
The RISE Registry is an enhanced version of the ACR's Rheumatology Clinical Registry (RCR) and allows for a simplified entry process, while establishing a best-in-class resource to manage your patient population and improve patient care. RISE provides participants with an infrastructure for robust quality improvement activities leading to improved patient outcomes, patient population management and quality reporting related to rheumatic diseases and drug safety. RISE gives physicians and researchers the information they need to optimize patient outcomes, meet reporting requirements, and make discoveries that advance rheumatology.
Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, the investigators will analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. The investigators expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.
B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans.
The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout.
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20