Assessment of Anxiety, Depression, Sleep Quality and Quality of Life in Rheumatoid Arthritis Patients...
Rheumatoid ArthritisThe goal of this case control observational study is to asses anxiety, sleep, depression and quality of life in rheumatoid arthritis patients The main aims are: asses anxiety, sleep, depression and quality of life in rheumatoid arthritis patients their relation to disease activity we will compare rheumatoid arthritis patients to healthy subjects.
An Observational Study to Evaluate Safety and Efficacy of Remsima™ in Patients With RA
Rheumatoid ArthritisAn Observational, Prospective Cohort Study to Evaluate Safety and Efficacy of RemsimaTM in Patients with Rheumatoid Arthritis.
Juvenile Arthritis Quantitative Imaging
ArthritisJuvenile Idiopathic2 moreThis observational study aims to develop and validate quantitative magnetic resonance imaging biomarkers as measures of disease activity in juvenile idiopathic arthritis (JIA). This includes patients with enthesitis-related arthritis (ERA).
Basal Joint Arthritis Prospective
Osteoarthrosis of the Carpometacarpal Joint of the ThumbThe study hypothesizes that there exist effective non-operative and operative treatments for certain patient populations with basal joint arthritis of the thumb. There also exists a functionally superior, cost effective, and low risk non-operative or minimally invasive operative treatment regime to alleviate pain and slow the progression of disease in those with less advanced disease. Likewise, there is significant functional, health utility, and economic advantage to surgically treating advanced basal joint arthritis with one of the popularized procedures currently in practice. Arthritis at the base of the thumb is a common condition associated with considerable patient discomfort. Many non-operative and operative treatments have been described, but few prospective studies involving multiple centers comparing these treatments have been done. By following patients from the start of their arthritis treatment and assessing their progress at certain time points using questionnaires and radiographs the investigators believe patient outcomes and satisfaction can improve. This study will include patients who are treated non-operatively and operatively and will not change patients' standard of care. By establishing standardized outcome measures and collecting data prospectively from the time of initial presentation through all treatment interventions it will be possible to directly compare treatments during the conservative and operative care of basal joint arthritis of the thumb. This multi-center study will identify those specific procedures or conservative treatments that have the greatest potential to be studied in subsequent focused and well-designed randomized control trials.
Atherosclerosis in Rheumatoid Arthritis and Lupus: Restoring Cholesterol Balance
Rheumatoid ArthritisHypothesis: SLE and RA increase risk of myocardial infarction (MI, heart attack). Immune reactants in the circulation of SLE patients downregulate cholesterol efflux proteins 27-hydroxylase and ABCA1 and upregulate scavenger receptor CD36, thus encouraging cholesterol accumulation. Adenosine A2A receptor agonist or statin treatment of cells exposed to SLE plasma (or immune complexes or cytokine-enriched plasma fractions from SLE patients) may ameliorate inflammatory properties of their plasma, lessening its atherogenic potency. Rationale: SLE and RA plasma contain components not present in significant levels in normal plasma that could, individually or acting together, affect 27-hydroxylase, ABCA1 and CD36 expression. Candidate components include autoantibodies, immune complexes, and various cytokines. Statins reduce major cardiovascular events and death. Modulation of adenosine signaling participates in regulation of 27-hydroxylase and ABCA1. As a potential preventative and therapeutic approach to atherosclerotic cardiovascular disease, the investigators evaluate the effect of A2A receptor agonists and statins on atherogenic parameters in SLE and RA plasma. Experimental Plan: Quantitate 27-hydroxylase and several other proteins involved in cellular cholesterol uptake and excretion in THP-1 monocytes/macrophages and HAEC after exposure to plasma and plasma components from SLE patients (and controls) ± lipid loading with acetylated LDL with/without addition of A2AR agonist, statin, or both. Determine relative impact of immune complexes and cytokines on expression of proteins involved in cholesterol flux. Determine levels of proteins involved in cellular cholesterol influx/efflux in peripheral blood mononuclear cells isolated from RA, SLE and psoriatic arthritis patients and normal controls at baseline, then following incubation in culture media alone or with statin, adenosine A2A agonist or both statin + A2AR agonist.
Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment
Rheumatoid ArthritisThis multicenter, prospective Phase I study is aimed at testing the safety of F8IL10 via i.a. administration once every 4 weeks over 8 weeks in patients with RA who, despite treatment with stable doses (at least 3 months) of DMARDs (conventional, biologic and/or targeted synthetic), present arthritis flare(s) suitable for i.a. injections.
Exactech Shoulder Post Market Clinical Follow-up Study
Osteo Arthritis ShouldersOsteonecrosis7 moreThe objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.
The Clinical Features and Pregnancy Outcomes of RA Patients
Rheumatoid ArthritisPregnancy RelatedThis study includes RA patients in pregnancy, who are using different treatment regimens,including prednisone, hydroxychloroquine, and/or TNF inhibitors. The maternal disease activity, pregnancy outcomes, maternal and fetal safety are assessing during the trimester of pregnancy. The effects of different therapies and risk factors for adverse pregnancy outcomes will be analysis.
Cortisol Circadian Rhythm in Patients With RA
Rheumatoid ArthritisThe European League Against Rheumatism (EULAR), acknowledging the critical issue of the complications, of long term treatment with glucocorticoids in the most recent update of the management guidelines for Rheumatoid arthritis, recommends tapering (on sustained clinical remission) of oral glucocorticoids treatment at the earliest feasible time point of therapeutic course and to the lowest daily dose, preferably <7.5mg/day (prednisone equivalent), until the final target of withdrawal is succeeded. In clinical practice, these guidelines are often difficult to follow due to the high risk of disease flares after tapering or stopping glucocorticoids administration. This inability of tapering oral glucocorticoids below 7.5mg/day of prednisone or an equivalent synthetic glucocorticoid is included in the recent definition of difficult-to-treat Rheumatoid arthritis. SΕΜΙRΑ (Steroid EliMination In Rheumatoid Arthritis) study, a double-blind, multicentre, randomised controlled trial, compared oral glucocorticoids tapering with the continuation of low dose oral glucocorticoids. The population study consisted of 259 RA patients with low disease activity on treatment with 5mg per day prednisone and tocilizumab, an anti-interleukin (IL)-6 receptor antibody. The study demonstrated that the continued-prednisone regimen provided better maintenance of disease remission than did the tapered-prednisone regimen for the study period of 24 weeks with no symptoms suggestive of AI. However, the study protocol did not include biochemical assessment of adrenocortical function. Experimental and clinical data have suggested that inadequate production of endogenous cortisol relative to enhanced clinical needs associated with the systemic inflammatory response, coined as the 'disproportion principle', may operate in Rheumatoid arthritis. Although the underlying molecular mechanisms remain unknown, both chronic overexpression of proinflammatory cytokines and chronic stress may contribute in the hyporesponsiveness of the hypothalamic-pituitary-adrenal axis and the target tissue glucocorticoid resistance that have been described, but not systematically studied. Thus, a precise longitudinal assessment of endogenous cortisol production may be needed for optimal management of patients with Rheumatoid arthritis. Based on the above, the investigators seek to investigate the hypothesis that an impaired functional reserve of adrenal cortex, due to chronic over-expression of pro-inflammatory cytokines and/or chronic stress may contribute to the development of Rheumatoid arthritis and/or associate with difficult-to treat RA. If this is the case, then a disturbed cortisol circadian rhythm reflecting this impairment may serve as a predictor of difficult-to-treat RA during the first diagnosis. In order to address this issue, the investigators designed a prospective cohort study including adult patients with Rheumatoid arthritis who require drug treatment for the first time or escalation of existing treatment due to active disease. Patients will be treated as per clinician's judgement with any kind or combination of DMARDs with or without corticosteroids (corticosteroid regimens when started will not exceed 15 mg/day, and will be given for at least 3 months), following EULAR recommendations for RA treatment. Patients will be monitored at baseline, 3 months, 6 months and 12 months, assessing disease response to treatment, the need for continuing glucocorticoid treatment, inflammatory indexes, and diurnal salivary cortisol levels. Patients' classification will be based on EULAR response to treatment criteria for RA and cortisol circadian rhythm will be comparatively assessed (at baseline and at 3/6/12 months) between groups based on treatment response (EULAR guidelines).
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Rheumatoid ArthritisArthritis of Ankle2 moreThe objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.