Giant Cell Arteritis

This clinical trial focuses on giant cell arteritis (GCA), a common systemic vasculitis affecting older adults. The study evaluates a new imaging tracer called AzaFol using PET/CT scans to diagnose GCA. Researchers aim to compare AzaFol with the standard 2-[18F]FDG-PET/CT imaging to determine if AzaFol better distinguishes inflammation caused by vasculitis from atherosclerosis. The trial also assesses the safety and tolerability of AzaFol in people suspected of having GCA. Participants will receive both AzaFol-PET/CT and FDG-PET/CT imaging in a randomized order. One group undergoes AzaFol imaging first followed by FDG, while the other group has FDG first then AzaFol. The study is open-label and randomized, with imaging performed at a single timepoint per participant to compare the two tracers directly. During the study, participants will be evaluated mainly by the imaging results to measure the specificity and sensitivity of GCA diagnosis using AzaFol compared to FDG. Researchers will also analyze lesion detection rates visually and semi-quantitatively. Safety and tolerability of AzaFol will be monitored, and participants must comply with protocol requirements, including fasting and remaining still during scans. The study participation duration for each person is centered around these imaging procedures and assessments.

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 gathering detailed real-world information on people with chronic wounds and ulcers to better understand their medical journey and treatment outcomes. This observational registry collects data from over 1,400 healthcare providers across the USA and Puerto Rico using a specialized electronic health record system. It includes all major wound types such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Participants receive care as usual from their clinicians, who use standard and advanced wound treatments like specialized dressings, compression therapy, offloading devices, cellular and tissue-based products, negative pressure therapy, ultrasound therapy, topical oxygen, hyperbaric oxygen, growth factors, debridement, and topical antibiotics. Data on treatment practices, wound characteristics, patient health conditions, and complications are collected continuously during routine care. Patients may be followed for over five years to track long-term outcomes. During the study, researchers collect information on patient demographics, wound details, treatment methods, visit frequency, and complications. They monitor healing progress, amputations, deaths, wound recurrence, hospitalizations, and other outcomes. The registry uses a wound healing index to adjust for risk and supports quality improvement and research by linking clinical data with insurance claims for comprehensive analysis. This ongoing effort helps to better understand wound healing and treatment effectiveness in everyday healthcare settings.

Researchers are evaluating the effectiveness of abatacept, given by weekly injection, in people aged 50 and older who have been newly diagnosed with or have relapsing Giant Cell Arteritis (GCA). This is a Phase 3 randomized, double-blind, placebo-controlled trial aiming to compare abatacept with placebo in achieving remission of GCA. The study is sponsored by the University of Pennsylvania and includes patients with active disease within 8 weeks prior to screening. Participants will be randomly assigned to receive either abatacept 125 mg or a placebo by subcutaneous injection once a week for at least 12 months. Those who reach remission will continue their assigned treatment for 12 months before stopping. If a participant does not achieve remission by 3 months, or experiences a relapse or disease worsening within the first year, they may enter an open-label phase to receive abatacept for up to 12 months. During the study, participants will be monitored regularly to assess remission status, safety, and quality of life using questionnaires like SF-36 and PROMIS. Researchers will measure the proportion of participants in remission at 12 months, duration of glucocorticoid-free remission, and the safety of abatacept. The total involvement may last up to 24 months if the participant enters the open-label extension. Close follow-up will ensure treatment adherence and assess any disease progression or side effects.

Researchers are conducting a nationwide registry in Armenia to observe and track systemic autoimmune and autoinflammatory diseases. These diseases involve abnormal immune system activity causing widespread inflammation and organ damage, often influenced by genetics and environmental factors. The study aims to better understand disease progression, which is usually measured by specific activity scores, and to gather detailed epidemiological and clinical data, as current knowledge in Armenia is limited. The study involves usual medical care for patients diagnosed with these systemic diseases, alongside collecting additional blood and stool samples for biobanking. Data collected include clinical exams, lab results, current treatments, and disease-specific activity scores reported by both patients and physicians. This observational registry will continue for about five years, assessing disease manifestations and evolution under treatment. Participants will be regularly evaluated through clinical and laboratory assessments, with data recorded on disease activity and progression. The study monitors systemic symptoms and uses disease-specific scores to track changes over time. Researchers will identify rare clinical forms and prognostic factors. The registry includes informed consent procedures and follows patients longitudinally to improve understanding of these complex diseases and their management.

This research aims to improve understanding, diagnosis, and management of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR), conditions involving inflammation of blood vessels and muscles. The study focuses on identifying immune system markers and using advanced imaging techniques to better detect disease activity, complications, and treatment responses. It also seeks to enhance diagnostic accuracy and develop personalized treatment strategies for these diseases. Participants diagnosed with GCA and/or PMR will undergo detailed immunological profiling, including cytokine analysis and immune cell phenotyping, using methods such as flow cytometry, ELISA, and RNA sequencing. Imaging assessments will include MRI, optical coherence tomography angiography, vascular and transorbital ultrasound, and contrast-enhanced ultrasound to detect vascular and neuro-ophthalmological involvement. Healthy volunteers matched by age and gender will serve as controls, undergoing similar assessments without treatment. Throughout the study, participants will be evaluated at multiple time points up to 18 months after diagnosis, including during disease flare-ups. Assessments include laboratory tests, imaging scans, and functional questionnaires to monitor disease progression, immune changes, and complications. Researchers will track outcomes such as neuro-ophthalmological, cardiac, and aortic involvement, as well as immune markers in blood. The study aims to provide new diagnostic standards and improve management and quality of life for affected patients.

Researchers are evaluating the link between ultrasound-detected lesions in temporal and axillary arteries and relapse in patients with giant cell arteritis, a disease affecting medium and large blood vessels. This prospective, bicentric longitudinal observational study aims to understand how ultrasound abnormalities relate to disease relapse and clinical outcomes, using the OGUS score as a predictive tool. The study involves patients routinely monitored for giant cell arteritis who receive temporal artery ultrasound as part of their standard care. There are no additional interventions or treatments, as this is a non-interventional study. Participants will undergo three visits including clinical, biological, and ultrasound assessments over the course of their routine follow-up. Participants will have clinical examinations, blood tests including C-Reactive Protein and Sedimentation Rate, and ultrasound imaging at baseline, 6 months, and 12 months. Researchers will track relapse based on EULAR 2018 criteria at 6 and 12 months, along with various clinical and biological markers. The study includes no extra costs or constraints and aims to follow patients for up to 12 months after enrollment.

Researchers are investigating the role of hematopoietic mutations, specifically mosaic loss of the Y chromosome (mLOY), in autoimmune rheumatologic diseases. This study, called AYLo, focuses on understanding how these mutations affect immune system balance, cell functions, and the progression of inflammation-related autoimmune disorders. The goal is to fill knowledge gaps about how these mutations contribute to disease and to develop a framework for disease-specific characterization using clinical, molecular, and imaging data. The study includes groups of male patients over 50 years old newly diagnosed with various autoimmune and respiratory conditions such as giant cell arteritis, polymyalgia rheumatica, ANCA-associated vasculitis, rheumatoid arthritis, sarcoidosis, COPD, and asthma bronchiale, as well as age- and gender-matched healthy controls. Participants will undergo diagnostic tests including single nucleotide polymorphism genotyping, 3'mRNA sequencing, ELISA and Legendplex assays for cytokine levels, flow cytometry for immune cell profiling, laboratory serum chemistry, and routine pulmonary assessments like lung ultrasound and CT scans. Assessments occur at baseline and again 12 months after diagnosis. Participants will provide blood samples and undergo clinical and imaging evaluations to measure the proportion of blood cells with mLOY and changes in immune cell types and cytokine profiles. Researchers will also monitor pulmonary involvement related to these diseases. The primary outcome is quantifying mLOY in hematopoietic cells, with secondary outcomes including immune and cytokine changes and lung involvement. Follow-up occurs twelve months after diagnosis to track disease progression and mutation impact. The total participation duration will cover this baseline and one-year follow-up period.

Researchers are investigating autoimmune diseases, systemic vasculitis, and autoinflammatory diseases to find biomarkers in cytokines and lymphocytes that show disease activity. The goal is to develop follow-up markers that help personalize monitoring and treatment for each patient. These diseases affect the immune system with varying severity, and current treatments mainly control inflammation but often lead to relapses without clear ways to predict them. The study collects blood and tissue samples as part of regular patient care to analyze immunological data. Conducted at a specialized medical center certified for rare autoimmune and inflammatory diseases, this observational study focuses on advancing fundamental knowledge and identifying prognostic markers through blood tests. Participants include patients with various autoimmune and autoinflammatory diseases who will provide additional blood samples beyond routine care. Participants will undergo biological sample collection during their usual care visits, with researchers monitoring cytokine and lymphocyte profiles over approximately nine years. The study aims to correlate these immune profiles with disease activity, progression, clinical presentation, and relapse frequency. This long-term observation helps understand disease evolution and supports personalized care. Safety and usual medical care continue throughout the study period.