Clinical Research Directory

Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases

The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age. The main questions it aims to answer are: Does the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs? Researchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles. All participants will: * receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection; * undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses; * attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests; * report any symptoms or adverse events using a standardized diary for 42 days; * be followed for up to one year for long-term safety and immunogenicity assessments. * wear a device for 14 consecutive days to assess current and habitual physical activity levels. * answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status. * collect blood samples one-year after vaccination to access immunogenicity and cellular response. Researcher will also perform subgroups analysis in: A viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration. An immunogenicity subgroup (\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.

Tofacitinib in Juvenile Idiopathic Arthritis

This study aims to evaluate, using real-world clinical practice data, the efficacy of tofacitinib in improving the clinical control of juvenile idiopathic arthritis (JIA) after 12 months of treatment.

Structured vs. Exergaming-Based Core Stabilization in Children With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA) is the most common inflammatory, autoimmune, and chronic rheumatic disease of childhood (1). In individuals diagnosed with JIA, increased inflammation leads to joint swelling, tenderness, restricted range of motion, and pain (2,3). Over time, these symptoms may result in impaired movement and proprioception, reduced muscle strength, and gait abnormalities (2,3). Although ongoing medical treatment has been demonstrated to be highly effective in suppressing inflammation in children with rheumatic diseases, persistent pain despite treatment may limit mobility and contribute to the development of kinesiophobia. This condition may lead to the adoption of a sedentary lifestyle (4). A sedentary lifestyle may subsequently result in reduced functional capacity and physical fitness, increased risk of social isolation, and a decline in overall quality of life (5). According to the literature, physical activity in children with rheumatologic diseases has been shown to reduce inflammation, increase muscle strength, improve functional capacity and mental health, reduce fatigue, and enhance quality of life (6,7). Non-pharmacological therapeutic exercise interventions have been found effective in alleviating chronic disease-related symptoms in children and in preventing secondary complications (8). The effectiveness of exercise therapy in children with JIA has been demonstrated in several studies, with commonly used programs including balance, proprioception, resistance, and range of motion exercises (9). However, only a limited number of studies have incorporated core-focused stabilization exercises into treatment protocols for children with JIA. Although Core Stabilization Training (CST) initially gained popularity among athletes, it has since been integrated into rehabilitation programs and applied across various patient populations (10,11). CST is defined as the ability to control muscle activation in the lumbo-pelvic region, which is necessary for spinal stabilization and for transferring core strength from the trunk to the extremities. CST has been shown to positively affect standing, sitting, balance, postural stability, and gait (12). A review of the literature confirms that Core Stabilization Training (CST) has beneficial effects on quality of life, pain, cardiorespiratory fitness, and functional ability (13). In studies involving children with Juvenile Idiopathic Arthritis (JIA), CST interventions were typically applied over a period of 12 weeks, with 2-3 sessions per week. The outcomes observed in this population were consistent with findings in the broader literature, supporting the effectiveness of CST in children with JIA (14). Exergaming has emerged as an innovative approach to integrating physical activity into daily life (15). In the literature, exercise programs utilizing exergaming across various populations are frequently encountered. These studies have demonstrated multiple benefits of exergaming, including promoting physical activity, reducing perceived exertion, adapting physical activity to individual needs, and improving physical fitness (16). In children diagnosed with JIA, exergaming programs have shown improvements in physical performance and exercise skills, as well as significantly enhanced patient satisfaction (17). However, to date, no study has been identified in the literature that investigates the use of exergaming-based core stabilization training specifically in children with JIA. The aim of the study is to compare the effects of an exergaming-based core stabilization training program and a structured core stabilization training program on physical fitness and functional capacity in children with Juvenile Idiopathic Arthritis (JIA). The study is designed as a randomized controlled trial. Children diagnosed with JIA will be included and randomly assigned to one of two groups. One group will receive structured core stabilization training, while the other will receive core stabilization training through exergaming. Both interventions will be administered over a 12-week period, with sessions held twice per week, each lasting 45 minutes. To the best of available knowledge, this will be the first study to investigate the effectiveness of a core stabilization exercise program using exergaming in this population. This study is expected to contribute valuable insights to the literature on improving physical fitness and functional capacity in children with Juvenile Idiopathic Arthritis (JIA). Furthermore, it will provide the first clinical and scientific evidence regarding the innovative use of exergaming as a method for delivering core stabilization exercises.

Investigation of Catastrophizing of Pain Reported by Parents in JIA Patients

Juvenile idiopathic arthritis (JIA) is the primary rheumatic disease reported to affect the pediatric population. Research suggests that parents' thoughts and feelings about their child's pain, specifically with JIA diagnosis, may influence treatment compliance. Considering that this situation may also affect children's adherence to treatment, the identification and management of parents' catastrophizing of pain is emphasized as important in improving treatment outcomes. This study aimed to examine the biopsychosocial characteristics of parents of children diagnosed with JIA according to their reported catastrophizing of pain.

Angiogenic Biomarkers in Juvenile Idiopathic Arthritis

The aim of the study is to determine whether serum inflammatory angiogenic markers (eg, semaphorins, CCN1) predict severity of juvenile idiopathic arthritis defined by structural progression and/or therapeutic escalation.

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.

Quantification & Classification of Inflammatory Cells in Uveitis Using OCT

The goal of this study is to determine if it's possible to use a high resolution imaging device called optical coherence tomography (OCT) to develop an unbiased, standard method of counting and categorizing the various types of cells and proteins found in an eye condition called anterior uveitis. Anterior uveitis is a type of inflammation in the eye that can be caused by many different diseases of the body.

CAPRI National Juvenile Idiopathic Arthritis Registry

Juvenile Idiopathic Arthritis (JIA) is a disorder of unknown cause characterized by chronic inflammation of the joints and other organs. It affects about 1 in a 1000 Canadian children and if untreated it can produce lifelong disability. The Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) includes most pediatric rheumatologists in Canada. They have successfully collaborated for the past 20 years producing groundbreaking research on the modern course and outcomes of JIA. The CAPRI JIA Registry is an ongoing universal registry of Canadian children with JIA that collects longitudinal data on disease course, outcomes and adverse events to inform healthcare decisions and to gain new insights into the disease and its treatment.

Reliability and Validity of the Glittre Activities of Daily Living Test in Children and Adolescents With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA) is children's most common inflammatory rheumatic disease. The International League of Associations for Rheumatology (ILAR) defines it as a chronic arthritis condition that begins before the age of 16 lasts for six weeks or more, and has an unknown cause. Despite the gains made in the management of the disease of individuals with JIA with modern medical treatment methods, the physical and psychosocial problems caused by chronic inflammation negatively affect the daily living activities of individuals with JIA. On the other hand, in the JIA Core Set created by Outcome Measures in Rheumatology (OMERACT) in 2018, activities of daily living were included as a "mandatory area that should be evaluated in all studies." Therefore, to ensure that individuals with JIA reach a state of complete well-being, multi-interdisciplinary health professionals are expected to address the activities of daily living, identify the factors that limit these activities, and create intervention plans for the factors to be determined. The literature shows that the daily living activities of patients with JIA are addressed with a limited number of subjective measurement tools. However, these methods have disadvantages due to their subjectivity. In this case, objective measurement methods are needed to quantify the physical performance of patients with JIA in terms of their daily living activities. The Glittre Activities of Daily Living Test, initially developed by selecting activities similar to daily living activities to evaluate functional capacity in pulmonary diseases, has the potential to address this gap. Since the activities in the test require using both the lower and upper extremities, it has the advantage of reflecting functional capacity and providing information about performance in daily life activities. Although it has potential, the Glittre Activities of Daily Living Test needs appropriate psychometric properties for clinical settings and research for JIA patients. To our knowledge, no studies have been conducted in the current literature on the validity and reliability of the Glittre Activities of Daily Living Test in JIA patients. Therefore, this study aimed to evaluate the test-retest reliability, construct validity, and minimum detectable change of the Glittre Activities of Daily Living Test in assessing activities of daily living in children and adolescents with JIA.

Evaluation of the Efficacy and Tolerability of an Exclusion Diet in Patients With Juvenile Idiopathic Arthritis

The JIA-ED study is a pilot project. Based on experience in another inflammatory disease, a 4-week period was extrapolated as sufficient to assess the effectiveness of the experimental intervention. This observation is supported by literature data showing that, halfway through phase I of the CDED (Crohn Diseasse Exclusion Diet), it is already possible to identify a subset of patients with Crohn's disease who are responsive to the dietary treatment and who also have a higher likelihood of achieving clinical remission by the end of the first phase of the diet itself.

Study on Eating Habits and Association with "omic" Profiles in Families with a Subject Affected by a Chronic Immune-mediated Inflammatory Pathology. Observational Multicenter Study.

The proposed study is part of a PNRR 2022 project (call "Non-Communicable Chronic Diseases (NCDs) with high impact on healthcare and social assistance systems," currently awaiting funding response) and represents the continuation of an observational clinical study named TRANSMIC, approved by the pediatric ethics committee of the Tuscany region. TRANSMIC was an integral part of a European research project within the joint programming initiative (JPI), under the HDHL-INTIMIC theme: "A Healthy Diet for a Healthy Life," aimed at understanding the cause-effect relationships between diet, gut microbiome, and human health. Understanding the role of diet in inflammatory bowel diseases (IBD) and exploring its role in autoimmune inflammatory conditions with joint manifestations, such as JIA, provides additional insights into the development, progression, and management of these conditions, opening new horizons for the use of dietary treatments in preventing these inflammatory conditions.

Gait Profile and Variables in Pediatric Rheumatic Disease Using a Smart Insole System

In pediatric rheumatic diseases, joint swelling, effusion, tenderness, and painful restriction of joint movement, particularly in weight-bearing joints, frequently alter walking function. These changes affect temporal and spatial parameters of gait, as well as kinematic and kinetic characteristics, leading to functional limitations. Comprehensive physical assessments in patients may not always predict changes in gait parameters. Therefore, incorporating objective methods related to gait and balance into physical evaluations is essential for functional insights and clinical decision-making, aiming to prevent adaptive mechanisms that could negatively affect gait function in the long term. In this context, smart insoles have emerged as a new tool for gait analysis, offering an alternative to high-cost, lab-based equipment. The Digitsole Pro® system can measure gait profile and variables in real-life conditions. A review of the literature reveals no studies utilizing smart insole-based gait assessments in pediatric rheumatic patients. The aim of our study is to investigate the gait profile and variables of children and adolescents with pediatric rheumatic disease using the next-generation Digitsole Pro® smart insole system, and to compare the results with those of healthy peers.

Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remission

Biologic therapies made clinical remission an achievable goal for most juvenile idiopathic arthritis (JIA) patients. Nevertheless, antirheumatic drugs have side effects and are costly. Currently, no guidelines exist for withdrawing drugs in JIA patients with clinical inactive disease (CID). Relapses following the withdrawal of antirheumatic drugs are common. To establish an optimal timeline for treatment discontinuation is a major unmet need in pediatric rheumatology. It is hypothesized that biomarkers-guided early withdrawal of antirheumatic drugs in patients achieving clinical, imaging and biological remission is safe and more effective compared to the standard practice of maintenance of stable treatment over 12 months.