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 injections in children with moderately to severely active ulcerative colitis, Crohns disease, or juvenile psoriatic arthritis. This Phase 3 study focuses on pediatric participants who have previously been treated with guselkumab and will continue therapy in this extension study to monitor safety over an extended period. Participants who completed dosing in one of three primary pediatric guselkumab studies and are deemed by their investigator to benefit from continued treatment will join this long-term extension. Guselkumab is administered as a subcutaneous injection either every 8 weeks or every 4 weeks, depending on prior study assignment and clinical status. Some participants may switch dosing frequency once during the extension before unblinding, after which dosing aligns with their original regimen. Dose adjustments are restricted based on the primary study they came from. During the study, participants will receive guselkumab injections regularly and be monitored for treatment-emergent adverse events for up to nearly seven years. Researchers will assess safety outcomes through ongoing clinical evaluations over this time. Parents or legal representatives provide consent for children to participate, and children capable of understanding the study will give assent. The total participation duration may extend up to six years and nine months, allowing long-term safety data collection.

Researchers are studying the safety and performance of the LEGION Medial Stabilized insert used in total knee arthroplasty TKA for patients with degenerative joint disease such as osteoarthritis, post-traumatic arthritis, or inflammatory arthritis. This observational study includes both prospective and retro-prospective participants and aims to provide long-term evidence to support product registration worldwide. The study involves three groups receiving different LEGION MS insert combinations with tibia and femoral components Cemented CoCr, Cemented Oxinium, and Cementless options. Participants will be followed for 10 years after their primary knee replacement surgery to monitor outcomes related to the implant. During the study, participants will undergo regular assessments including the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement KOOS JR, Oxford Knee Score, Forgotten Joint Score, and EuroQol Five-Dimensional EQ-5D-5L questionnaires at multiple timepoints from 6 weeks up to 10 years post-surgery. Implant survivorship will be tracked at intervals up to 10 years, with all participants consenting to follow-up visits and outcome reporting to evaluate long-term device safety and effectiveness.

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 8mgkg 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 drugs 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 ParentPatient 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 the long-term safety of apremilast in children aged 2 years or older with oral ulcers linked to Behets 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.

This research aims to evaluate the long-term safety and effectiveness of the drug baricitinib in treating juvenile idiopathic arthritis JIA in children and adolescents aged 1 to under 18 years. Participants in this study have previously taken part in other baricitinib studies for JIA. The purpose is to monitor how well baricitinib works and to assess any serious side effects over an extended period. Participants will receive baricitinib orally during the study. This is a single-group trial where all participants receive the same treatment. The study follows participants for a total duration of up to 264 weeks approximately 5 years, during which they will be monitored closely for safety and disease activity. Throughout the study, participants will have regular assessments including monitoring for serious adverse events and treatment discontinuations. Researchers will also evaluate disease activity, pain levels, and other health measures using various clinical tools at baseline and at the end of the study period. This long-term follow-up ensures thorough evaluation of baricitinibs impact and participant well-being.

Researchers are evaluating the treatment patterns, long-term clinical outcomes, and demographic characteristics of patients diagnosed with Familial Mediterranean Fever FMF and Stills disease, including systemic juvenile idiopathic arthritis SJIA and adult-onset Stills disease AOSD, who have received canakinumab for at least six months. The study aims to understand how canakinumab is used in real-world settings among these patient groups and to assess their responses over time. The study is observational and does not involve assigning any treatments. It includes patients who have been prescribed canakinumab prior to October 2021 and have used it for at least six months. The patient cohorts consist of those with FMF, SJIA, and AOSD. Researchers collect data retrospectively on clinical characteristics, treatment regimens, and medication use patterns over a period of at least three years following the start of canakinumab treatment. Participants medical records and treatment histories are reviewed to measure outcomes such as rates of clinically inactive disease, remission, response levels, and treatment discontinuation reasons over up to three years. Additional assessments include hospitalizations, medical visits, diagnostic and laboratory tests, and quality of life scores. This comprehensive data collection helps characterize patient experiences and treatment effects under usual care conditions without altering the therapy received.

Juvenile psoriatic arthritis jPsA is a form of arthritis where the immune system attacks healthy joints, causing pain, stiffness, and swelling. This condition starts before age 16 and can worsen or improve over time. Researchers are studying how safe risankizumab is for treating jPsA and how it affects disease symptoms compared with adalimumab, which is already approved for this condition. This is a Phase 3 interventional trial enrolling about 40 children worldwide to evaluate these treatments. Participants are randomly assigned to receive either risankizumab or adalimumab given as subcutaneous injections based on their body weight. The study has two periods Period 1 lasts 24 weeks, where participants receive the assigned treatment. Those who respond continue with the same treatment for another 100 weeks in Period 2. Participants who worsen in Period 2 will stop the study treatment. After finishing treatment, there is a safety follow-up lasting 140 days for risankizumab and 70 days for adalimumab. During the study, participants will visit hospitals or clinics regularly for medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. Researchers will measure improvements using criteria such as the Juvenile Idiopathic Arthritis American College of Rheumatology response and track adverse events up to week 144. The total participation time includes treatment periods plus safety follow-up, lasting several years.