View clinical trials related to Arthritis.
Filter by:The study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of multiple orally administered TCK-276 in both males and females with Rheumatoid Arthritis (RA).
The purpose of this study is to validate whether the use of a self-reported diary for orthosis use is accurate and valid. We will insert a temperature gauge into the orthosis during fabrication that measures temperature to an accuracy of one degree Celcius. This sensor is about the size of a watch battery, and patients will be told that it is measuring the force of stretch applied to the elbow, while in fact, it is measuring the amount of time that the orthosis is being worn. The temperature of the skin while wearing the orthosis heats up the sensor, and we can accurately predict (within 5 minutes of accuracy) how long the orthosis is worn each day. We will have patients also fill out a self-report diary outlining how long they are wearing the orthosis each day, and compare these times to the measurements taken by the sensor. As secondary outcomes, we will look at whether the orthoses improve elbow range of motion (ROM), patient satisfaction, and improvement over time on patient reported outcome measures. This study will provide important information about the validity and reliability of using diaries to measure adherence to orthoses, and will be the first to provide objective data regarding the actual use of these orthoses and whether they help to decrease elbow stiffness.
Perception of chronic pain and related disability; occurs through the interaction of physiological and psychological processes. Pain catastrophizing is a cognitive attribution style characterized by a negative mindset and magnification of pain. Catastrophizing in children has been associated with poor functioning and higher levels of pain. Catastrophizing during the transition to adulthood is defined as an important predictor of persistent pain and central sensitivity. The number of scales assessing pain and attitudes related to pain in children is quite low. In recent years, with the adaptation of the assessment scales used for adults to children or the development of new scales, the assessment of pain and pain-related attitudes in children has begun to be provided. Pain catastrophizing scale (PCS), in 1995 Sullivan et al. for the purpose of comprehensive assessment in adults experiencing pain-related disasters. In 2003, Crombez et al. showed the validity and reliability of the scale in school-age children. For predictive validity, the scale was administered to children with chronic pain, and it was reported to predict the severity of pain and pain-related disability. Pain Catastrophizing Scale-Child (PCS-C) scale; It is a self-report measure adapted from the Adult Pain Catastrophizing Scale used to assess negative thinking associated with pain. It contains 13 items rated on a 5-point scale ranging from 0 = "not at all true" to 4 = "very true". Substances; rumination (4 items, e.g. "When [my child] has pain, I can't get him out of my mind"), magnification (3 items, e.g. the child has pain], thinking about other painful events"), and helplessness (6 items, e.g. "[My child's]] When I have pain, I feel that I cannot continue"). Items are aggregated across subscales to obtain a total score ranging from 0 to 52; higher scores are related to higher catastrophizing attitude. The pain catastrophizing scale was originally developed in German and later validity and reliability studies were conducted in different languages. The aim of this study is to question the Turkish validity and reliability of the "Pain Catastrophizing Scale-Child (PCS-C)" scale.
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological DMARD (TNF inhibitors, anti-Interleukin 6 (anti-IL6)), abatacept, or rituximab) or a targeted synthetic (ts) DMARD (JAK inhibitors) is considered. Current practice is to start a bDMARD (biologic Disease Modifying Antirheumatic Drugs) and especially TNF inhibitors (etanercept or monoclonal anti-TNF antibodies) with the benefit of hindsight. However, abatacept and TNF inhibitors have demonstrated similar efficacy in patients with insufficient response to csDMARD (AMPLE trial). Although abatacept has shown a very good tolerance profile that might be superior to other bDMARDs rheumatologists might be reluctant to use it as a first line bDMARD as there is a belief of a slower efficacy compared to other bDMARDs or JAK inhibitors. Indeed, in real world study, compared to TNF inhibitors it seems that discontinuation of abatacept is more related to lack of effectiveness than safety issues. Investigators have hypothesized that first rapidly controlling the inflammation phase, using TNF inhibitors followed by abatacept to induce an immunological remission would optimize response and tolerance of ACPA positive patients with RA. To demonstrate our hypothesis, the investigaors propose a randomized controlled trial with one arm receiving an induction therapy for 12 weeks with a TNF inhibitor followed by a cell-targeted bDMARD (abatacept) and the other arm, receiving TNF inhibitors.
Patient preference and experience can impact patients' adherence and persistence regarding a treatment, especially when switching. A number of factors contribute to this, including their beliefs, fears, expectations, and overall knowledge. This is compounded by the fact that many switched patients are not trained on how to use the new injection device. Specifically, some patients report a degraded experience with current adalimumab biosimilars (40mg/0.8mL) as compared to the originator: injections appear more painful and seem to cause more bruising. Indeed, treatment-related factors such as treatment volume or the presence of citrate have the potential to negatively impact patient experience and contribute to local reactions at or around the injection site, such as pain and swelling. Yuflyma® (CT-P17 adalimumab), developed by Celltrion Inc., is a biosimilar of the anti-TNF treatment adalimumab, having obtained a marketing authorisation from the European Commission on 11th February 2021 (addressed to Celltrion Healthcare). Yuflyma® is the first high-concentration adalimumab biosimilar (40mg/0.4mL) available in France, which makes the product similar to the currently available adalimumab originator formula in terms of drug concentration. Studying patient experience over the course of a switch involves querying patients at the time of prescription, while they are still under the previous treatment, and for the following 3 months, during which they have been able to pick up their prescribed medication from a pharmacy and have started using the new treatment. Describing patient experience over the course of a switch from another adalimumab (originator or biosimilar) to Yuflyma® would contribute to identifying significant factors which contribute to patient experience and satisfaction. Our primary objective is to assess patients' overall satisfaction with the injection after the switch to the high-concentration adalimumab biosimilar Yuflyma®, at 3 months following the initiation, compared to their experience with the previous adalimumab. - Overall satisfaction with the injection (7-level likert) before initiation - Overall satisfaction with the injection (7-level likert) 3 months after initiation
Based on recent guidelines, the investigators have developed a parallel (patient and physician) educational web-based tool. To prove its effectiveness, the investigators have designed a cluster clinical trial of a 6-month duration in which 15 centres will be randomised to receive access and instruction on the strategy or to continue standard care. The trial endpoint is adherence at the patient level, for which each centre will recruit 15 consecutive patients and measure adherence (medication, physical activity, Mediterranean diet) and disease activity as of baseline and 6 months after.
TNFα inhibitors have revolutionized the management of patients suffering from inflammatory diseases in the field of rheumatology. Infliximab remains widely used in France, and infliximab biosimilars have been routinely used since 2015 in Cochin Hospital with an interchangeability strategy validated by two real life studies. REMSIMA® 120 mg is the first authorized subcutaneous (SC) form of infliximab to be administered at a fixed dose of 120 mg every 2 weeks. Scarce information is available regarding the safety and efficacy of proposing a switch from IV infliximab to SC REMSIMA® in the subsets of patients suffering from different rheumatic diseases in daily care. The primary objective of the SIC2 study will be determine the retention rate of Remsima SC at 6 months. The investigators will recruit adult patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis.
Through real-world observation, understanding clinical efficacy and safety of treatment with YISAIPU (etanercept biosimilar) for RA patients of Fujian Province for three years
Rheumatoid arthritis (RA) is an autoimmune disease in which a symmetrical Synovial inflammation, bone destruction occur in both small and big Joints. If left untreated, this illness does not generally cause death, but it does drastically affect the quality of life and life expectancy of patients. Although there is no cure for RA, patients are generally on long-term long-acting disease-modifying anti-rheumatic medications (DMARDs) to control joint inflammation, reduce joint damage, maintain joint function, and keep the illness in remission. RA disease activity could be detected be DAS28 score. The DAS28 is a four-item scale that gives an absolute number reflecting disease activity. It includes the number of swollen and tender joints (SJC, TJC), the visual analogue scale of patients' assessment of their general health (VAS-GH), and the erythrocyte sedimentation rate (ESR) in the first hour. In the pathophysiology of RA, cytokine networks play a crucial role. Rheumatoid inflammation has been linked to the generation of proinflammatory cytokines throughout time. Increased cytokine levels, such as tumour necrosis factor (TNF) and interleukin-6 (IL-6), represent rheumatoid synovial inflammation and have been linked to RA disease activity and anti-cytokine therapeutic response. The relationship between circulating cytokine levels and the phenotype of RA illness is, however, poorly understood. Anti-citrullinated peptide antibodies (ACPA) are effective in the diagnosis of RA and have been linked to joint destruction progression and therapy response in RA patients. However, the relationship between ACPA status and proinflammatory cytokines during the course of RA illness is yet unknown. Galectins are lectins with carbohydrate recognition domains (CRDs) that are extremely similar in sequence and exclusively bind to β--galactoside carbs. There are at least 15 galectins found in mammals, each having one or two CRDs comprising roughly 130 amino acids. Galectins have a wide range of activities due to their ubiquitous distribution, including mRNA splicing, programmed cell death, cell cycle control, activation, adhesion, migration, and cell differentiation. Galectin-9 (Gal-9) is abundantly present in lymph nodes, bone marrow, liver, thymus, and spleen. It is expressed by immune cells, endothelial cells, and fibroblasts and plays an important role in regulating inflammation and immune reactions. Gal-9 is a ligand for T cell immunoglobulin and mucin-containing-moleculte-3 (Tim-3) that is expressed on CD4+ T helper (Th) 1 and Th17 and sends inhibitory signals to Tim-3. As a result of its interaction with Tim-3, Gal-9 suppresses pro-inflammatory T cell responses, and the Gal-9/Tim-3 pathway causes apoptosis of CD4+ Th1 or Th17 cells. Considering that RA is a Th1-polarized autoimmune illness, dysregulated Gal-9 levels may induce an innate/adaptive immunity imbalance, resulting in pathological rheumatoid inflammation. Gal-9 has been demonstrated to mediate angiogenesis and inflammatory cell infiltration in inflammatory arthritis. These findings show that Gal-9 may have a role in the inflammatory processes of rheumatoid arthritis. As a result, we concentrated on Gal-9 and postulated that it could be involved in the pathogenesis of RA. The levels of serum Gal-9 in individuals with RA were studied in this study, and the results were compared to clinical indicators
The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).