Juvenile Idiopathic Arthritis

Researchers are evaluating a new MRI pulse sequence called 3D DL oZTEo to detect bone erosions in the hands of patients with inflammatory arthritis. The study aims to validate this technique against current standard methods like radiography and conventional MRI, as these structural changes are important for diagnosis and treatment decisions in rheumatic conditions. This is an interventional study conducted at Mayo Clinic. Participants will have the FDA-approved oZTEo MRI pulse sequence added to their routine hand MRI scan. The oZTEo images will be anonymized and processed using a deep learning algorithm developed by GE Healthcare. This additional sequence is assessed alongside the standard MRI to compare its ability to detect bone erosions. During the study, researchers will analyze MRI scans with and without the 3D DL oZTEo sequence to determine the presence and number of bone erosions in the hand. Participants must have recent hand radiographs confirming erosions and are scheduled for hand MRI as part of their clinical care. The study measures outcomes on the day of imaging and monitors the accuracy of erosion detection.

Researchers are evaluating the long-term safety of subcutaneous guselkumab in children with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. This study includes pediatric participants who have previously received guselkumab in primary studies and aims to monitor adverse events over an extended period. Participants who completed one of three primary pediatric guselkumab studies may join this long-term extension study if the investigator believes they will benefit from continued therapy. Guselkumab is given as a subcutaneous injection every 8 or 4 weeks, depending on the dosing regimen from the original study. Some participants have an option to adjust dosing frequency once during the extension, while others continue with their original schedule without changes. During the study, participants will have regular safety assessments focusing on treatment-emergent adverse events for up to nearly 7 years. Consent from parents or legal representatives and assent from children able to understand the study are required. Researchers will monitor participants closely, collecting data on safety and tolerability while allowing continued access to guselkumab throughout the extension period.

Takayasu arteritis (TAK) is a rare chronic inflammatory disease affecting arteries, and there is no widely accepted effective treatment strategy. Researchers classify TAK patients into three severity levels: mild, moderate, and severe. This study focuses on severe TAK patients and compares two biological agents, tocilizumab and adalimumab, to find which treatment may provide better intervention outcomes in this group. The study randomly assigns severe TAK patients to receive either tocilizumab at a dose of 8mg/kg intravenously every four weeks or adalimumab at 40mg biweekly by injection for 24 weeks. Patients start with prednisone at 40mg daily, tapered gradually over months, and treatment adjustments are made if disease relapse occurs. After 24 weeks, if remission is not achieved, patients switch to the other biological agent for an additional 24 weeks. Participants are monitored throughout treatment and follow-up for disease remission using clinical and laboratory assessments. Researchers track disease relapse, vascular progression through angiographic exams, prednisone dose reduction, and quality of life changes using questionnaires over a total of 48 weeks. The primary outcome is disease remission at 24 weeks. Safety and disease activity are closely observed during the study.

Researchers are studying the experiences of people who develop rheumatic immune-related adverse events (irAEs) after receiving immune checkpoint inhibitor immunotherapy. This study aims to understand how severe these events are, how they affect daily function, and the attitudes of patients towards different aspects of these side effects. The research focuses on conditions like arthritis and polymyalgia rheumatica that arise following this cancer treatment. This observational study does not involve any drug or treatment interventions. Instead, it gathers information through qualitative assessments from patients diagnosed by rheumatologists with inflammatory arthritis or polymyalgia rheumatica as irAEs after immune checkpoint inhibitor therapy. The study is sponsored by M.D. Anderson Cancer Center and will collect data over about one year. Participants will engage in interviews to share their experiences, which will help researchers evaluate the safety and adverse events associated with these immune-related conditions. The study includes monitoring adverse events throughout the study period. The total involvement duration averages one year, allowing for comprehensive understanding of the impact and progression of these rheumatic irAEs.

Researchers are studying the use of sarilumab, a drug given by injection, in children and adolescents aged 1 to 17 years who have systemic juvenile idiopathic arthritis (sJIA). The study aims to understand how the drug behaves in the body, its effects, and its long-term safety for treating this condition. This trial is a phase 2, open-label study sponsored by Sanofi, designed to find the best dose and treatment schedule for young patients with sJIA. Participants will receive sarilumab injections under the skin at doses that increase during the study based on body weight. The treatment includes a 12-week core phase where patients receive the drug, followed by a 144-week extension phase for continued treatment. After completing treatment, a 6-week follow-up period will monitor patients. The study includes careful dose adjustments and long-term observation to assess the drug's impact. Throughout the study, participants will undergo various assessments including blood tests to measure drug levels, evaluations of disease activity using scales like the Investigator Global Assessment and Parent/Patient Global Assessment, and tracking of symptoms and medication use. Safety will be monitored continuously by recording any side effects or local reactions to injections. The total participation time is about 166 weeks, during which the researchers will collect data on how well sarilumab works and how safe it is for children and adolescents with sJIA.

Researchers are evaluating adalimumab for patients with acute Vogt-Koyanagi-Harada (VKH) disease to test if it provides clinical benefits. This observational study divides participants into two groups: one receiving adalimumab therapy and the other receiving traditional treatment with glucocorticoids alone or combined with immunosuppressants. The study follows ethical guidelines and informed consent was obtained from all patients. In the adalimumab group, patients receive an initial subcutaneous dose of 80 mg, then 40 mg every two weeks. Therapy continues for six months after ocular inflammation subsides, followed by tapered injections until withdrawal after 40 days. The traditional therapy group follows glucocorticoid treatment starting at 1 mg/kg/day, gradually stopped over 90 to 180 days. The study lasts up to one year to track treatment outcomes and side effects. Participants undergo regular assessments including best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), and corticosteroid dose changes. Researchers monitor anti-inflammatory and immunosuppressive effects of adalimumab, visual acuity changes, and recurrence rate at 24 weeks. Prednisone exposure is also tracked over 12 months to evaluate treatment impact and safety throughout the study period.

Researchers are evaluating the long-term safety of apremilast in children aged 2 years or older with oral ulcers linked to Behçet's disease, and in children aged 5 years or older with active juvenile psoriatic arthritis who have completed prior related studies. This phase 3, multicenter, open-label extension study aims to monitor safety outcomes over an extended period. Participants receive apremilast orally in doses based on body weight: those weighing between 12 kg and less than 20 kg receive 10 mg twice daily, those between 20 kg and less than 50 kg receive 20 mg twice daily, and those weighing 50 kg or more receive 30 mg twice daily. The study continues treatment and observation over approximately four years, focusing on long-term effects. During the study, researchers will monitor participants for adverse events, changes in vital signs, laboratory parameters, growth measures such as height, weight, and BMI, and assess suicide risk using the Columbia-Suicide Severity Rating Scale. Tanner staging will also be evaluated to assess physical development. Participants are expected to attend scheduled visits and adhere to protocol requirements throughout the study period, which may last up to around four years.

Researchers are studying the safety and effectiveness of the drug baricitinib in children aged 1 to less than 18 years who have systemic juvenile idiopathic arthritis (sJIA). This study is a Phase 3 trial that compares baricitinib with tocilizumab in one group and evaluates baricitinib alone in another group. The goal is to understand how these treatments work for young patients with active joint disease due to sJIA. Participants are divided into two groups: Cohort 1 includes children who have not previously received IL-6 inhibitor therapy and are randomly assigned to receive either oral baricitinib or subcutaneous tocilizumab. Cohort 2 includes children who receive oral baricitinib without comparison. Treatments are given over several weeks, with key assessments planned at Week 12 and Week 24 to evaluate response and disease activity. Throughout the study, children will be monitored to see how many achieve specific improvements in their arthritis symptoms, measured by adapted pediatric response criteria and disease activity scores. Researchers will also track pain changes and baricitinib levels in the blood. The study involves regular visits for these assessments and safety checks, with participation lasting through Week 24 or longer as planned.

Researchers are evaluating the long-term safety and effectiveness of the drug baricitinib for treating Juvenile Idiopathic Arthritis (JIA) in children and adolescents aged 1 to less than 18 years. This Phase 3 study focuses on participants who have previously taken part in baricitinib studies for JIA. The goal is to understand how well baricitinib works and monitor any serious side effects over an extended period. Participants will receive baricitinib orally as part of the study treatment. The study tracks outcomes such as the frequency of serious adverse events, permanent discontinuations of the drug, and various measures of disease activity and symptoms including pain, disease flare, inactive disease, and remission. Assessments will collect data on arthritis activity, skin symptoms, and immune system markers during the study. During the study, participants will be monitored regularly through clinical evaluations and questionnaires to assess their arthritis symptoms, disease activity, and overall health. Researchers will measure outcomes from the start of the study through week 264, focusing on safety and how well the disease is controlled. The study is designed to ensure participants' health is closely observed while collecting important information on long-term treatment effects.

Researchers are evaluating the treatment patterns, long-term clinical outcomes, and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease, including systemic juvenile idiopathic arthritis (SJIA) and adult-onset Still's disease (AOSD). This observational study focuses on patients who have received canakinumab treatment for at least six months to understand its use in real-world settings across Europe and Israel. The study includes three groups of patients: those with FMF, SJIA, and AOSD, all of whom have been treated with canakinumab for at least six months. It tracks treatment use and responses over time, including the use of other biologic agents like anakinra and tocilizumab. The research assesses various outcomes up to three years after starting canakinumab, including disease activity, remission status, steroid usage, treatment switches, hospitalizations, medical visits, and quality of life. Participants' medical records and data will be reviewed for clinical characteristics, treatments, hospitalizations, diagnostic and laboratory tests, and quality of life measures over a follow-up period of up to three years. The study aims to measure how many patients achieve inactive disease or remission and track other treatment responses. Data collection includes information before, during, and after canakinumab treatment to provide a comprehensive understanding of patient outcomes and long-term management.