Drug Compliance and Affecting Factors in Juvenile Idiopathic Arthritis
ArthritisJuvenile Rheumatoid2 moreThe goal of this observational study is to learn about the drug compliance of patients with juvenile idiopathic arthritis and, to figure our factors that affect the compliance. The main questions it aims to answer are: Medication use and compliance in children with chronic diseases is an important problem, but do patients with JIA really use their medications in harmony? Does the level of adherence to medications affect the quality of life of patients with JIA? Participants will be asked to fill the demographic form which includes personal information and nutritional habbits, Morisky Drug Compliance Scale - 8 and the pediatric quality of life inventory forms, with attending researcher Yesfa Sebnem Ozbay, M.D. This study is not an interventional study.
Effectiveness and Feasibility of a Home-based Exercise Program for Adolescents With Juvenile Idiopathic...
Juvenile Idiopathic ArthritisJuvenile Arthritis1 moreThis study will aim to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA. For this, adolescents (< 18 years) with JIA will be randomized to a 12-weeks home-based exercise program or usual care (i.e., no exercise control intervention). The home-based exercise intervention will be delivered remotely using a video calling app, and participants will be instructed to perform 3 sessions of weight-bearing exercise per week. Participants will be supported by educational materials, a heart rate monitor, and through periodic contact with an exercise specialist via video and phone calls, and text messages. The study's primary outcomes will be: cardiac and vascular function and structure using ultrasound imaging, body composition (DXA), aerobic capacity, muscle strength and functional capacity. In addition to that, the feasibility, safety, acceptability, and barriers and facilitators to the intervention will also be assessed.
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and...
Still's DiseaseAdult-Onset2 moreThe aim of this study is to demonstrate the efficacy and to evaluate the safety, pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset Still's disease).
Etanercept Plus Methotrexate Versus Methotrexate Alone in Children With Polyarticular Course Juvenile...
Juvenile Rheumatoid ArthritisThe primary objective of this study was to determine the efficacy of etanercept plus methotrexate vs methotrexate alone in pediatric patients with active polyarticular course juvenile rheumatoid arthritis (JRA).
Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic...
Juvenile Idiopathic ArthritisPrimary Objective of the study: the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at least pediACR30 response);
Infliximab to Treat Children With Juvenile Rheumatoid Arthritis
Juvenile Rheumatoid ArthritisThis study will determine whether a stepwise increase of the drug infliximab (Remicade® (Registered Trademark)) controls juvenile rheumatoid arthritis more effectively than a fixed dose. It will look at the safety and effectiveness of increasing the dose to a maximum of 15mg/kg body weight per dose, examining the drug's effect on bone and cartilage, and whether it can improve abnormal growth, metabolism and hormones. Infliximab is approved for treating adults with rheumatoid arthritis and Crohn's disease. Children between 4 and 17 years of age with active juvenile rheumatoid arthritis who do not respond adequately to standard therapy may be eligible for this study. Participants will receive nine infusions of infliximab during this 62-week study. The drug is given intravenously (IV, into a vein) over 2 hours. The first three infusions will be at a dose of 5 mg/kg of body weight. Children who improve on this regimen will receive another 6 infusions at the same dose. Children who do not significantly improve on 5 mg/kg at the end of 6 weeks (the third infusion) may continue with phase 2 of the study, in which they will be randomly assigned to receive either: 1) 6 additional doses of the drug at 5 mg/kg per dose, or 2) a gradually increased dose to a maximum of 15 mg/kg. In addition, all children will continue to take methotrexate at the same dose as when they entered the study. Participants will visit the NIH Clinical Center 12 times (about every 8 weeks) during the study for the following tests and procedures: History and physical examination, including a complete joint exam Puberty assessment - breast development in girls, testicle size in boys, and pubic hair Height and weight measurements Children will have imaging studies (x-rays, MRI and Dexa scan) at the beginning and end of the study and will collect a 24-hour urine sample before each infliximab infusion. Patients may elect to have an endocrine evaluation. This involves Clinical Center hospitalizations for 1-1/2 days on visits 1, 4 and 12. Small amounts of blood will be drawn every 20 minutes (through an indwelling catheter to avoid multiple needle sticks) for 8 hours while the child sleeps. The blood will be examined for the normal rhythm of growth hormone and other substances in the body and how they are affected by arthritis. Participants will complete a questionnaire once a year for 2 years to provide information on their health status and any problems that might be related to the study drug.
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid...
Juvenile Rheumatoid ArthritisThe primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).
A Study to Evaluate Camoteskimab in Participants With Still's Disease
Adult Onset Still's DiseaseThe main purpose of the study is to evaluate the safety and tolerability of Camoteskimab in participants with Still's Disease.
Acostill ( RaDiCo Cohort) (RaDiCo Acostill)
Still DiseaseStill's Disease3 moreAdult Onset Still Disease (AOSD) and Systemic onset Juvenile Idiopathic Arthritis (SoJIA) are two rare multifactorial diseases associated with systemic inflammation. These two forms AOSD and SoJIA are considered to be two facets of the same syndrome, combining four cardinal symptoms [hectic fever> 39 °, arthralgia or arthritis, skin rash, a leukocyte formula with more than 80% of neutrophils]; lymphadenopathy and splenomegaly may also be found. There is an important biological inflammatory syndrome with elevation of the reactive C protein, of serum ferritin with a dramatic drop in the glycosylated fraction. The incidence of the disease is low, around 0.1/100,000 for adults and 0.6/100,000 for children. Its prevalence is approximately 1 to 3/100,000 and 3/100,000 for children, so there are approximately 500 to 1,500 adults and 450 children affected in France. It is subdivided into pediatric and adult forms according to the age of onset before or after 16 years. The prognosis of the disease is functional and vital. Macrophage activation syndrome (SAM) is frequently associated with either the onset of the disease or the initiation of treatment or concomitantly with viral reactivation. The course over time has mainly been studied in children and is variable: regression, course by flare-ups with term regression and chronic joint development. In adults we can also observe these 3 evolutionary modes. However, differences seem to exist between AOSD and SoJIA. The various clinical questions posed by this disease are as follows: Why does it differentially affect two age groups of the population? Why is the clinical expression heterogeneous with pure systemic or articular forms, the frequency of SAM, and rare organ damage? Why is the evolution over time different with resolving monocyclic forms or polycyclic forms and sometimes chronic evolutions? These differences could be explained by distinct underlying pathogenic mechanisms. But at present, the pathophysiology of this entity remains unknown, although several hypotheses can be formulated involving several pathophysiological pathways. The pathogenesis of Still's disease has not yet been elucidated but there is a significant inflammatory reaction without the production of autoantibodies, which makes this disease a form of autoinflammatory syndrome with abnormalities of the innate immunity (activation of macrophages, strong elevations of pro-inflammatory cytokines: interleukins 1 and 18, possible abnormalities of inflammasomes and NK cells). The treatment is based on anti-inflammatory drugs, corticosteroids with the usefulness of methotrexate and anti-TNF in the event of significant joint damage. Interleukin 1 and 6 inhibitors have been shown to be effective in this disease. In adults and children, there are forms that are refractory to treatment, with a risk of AA amyloidosis for these patients. The expected outcomes of this work are to improve knowledge of Still disease and patient management on the following aspects: Comparison of pediatric and adult forms (which has never been done on a large number of patients), Better understanding of the pathogenic mechanisms of the disease, The identification of early diagnostic/prognostic markers, The possibility of promoting the evaluation of new therapies to come thanks to the constitution of an active file of patients with a standardized follow-up. The ACOSTILL study group is thus a unique collaboration of adult clinicians (rheumatologists and internists) and pediatricians, who have decided to unite their efforts to increase knowledge about the pathogenesis of Still disease in order to better understand the disease and improve care pathways. Many of them participated in the development of the national diagnostic and care protocol published in 2018.
Massage Therapy in Juvenile Idiopathic Arthritis
Juvenile Idiopathic ArthritisWhile there has been progress in juvenile idiopathic arthritis (JIA) management, there is no cure. Despite receiving standard of care, many children live with pain. Thus, it is not surprising that families turn to complementary and alternative medicines (CAM) therapies, including massage therapy (MT). Little is known about the efficacy of MT in JIA. In this project, a massage therapist will teach parents how to provide a massage to their child with JIA at bedtime, at home. The feasibility of establishing a home MT program for children with JIA will be evaluated. In addition, the effects of MT on JIA will be examined. This proposal is relevant to JIA families, who ask questions on MT to professionals of the JIA clinic. Beyond providing education to JIA families, this project demonstrates the team approach to JIA management. Team members will include a pediatric rheumatology nurse and a massage therapist.