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 evaluating the effectiveness and safety of a precision treatment plan tailored to clinical-molecular phenotypes compared with a conventional treatment approach in adults with active Takayasu's arteritis. This randomized, controlled, open-label, multicenter study aims to provide clearer insights into managing this condition by assessing outcomes over a 14-month period, including a 6-month induction remission phase and an 8-month maintenance phase. Participants will be randomly assigned to either the precision therapy group or the conventional therapy group. The precision group receives treatments based on their clinical-molecular phenotype: constitutional type patients get glucocorticoids combined with tocilizumab and methotrexate; vascular inflammation type patients receive combinations involving glucocorticoids plus tofacitinib, tocilizumab, adalimumab, and methotrexate depending on specific cytokine elevations. The conventional group receives traditional treatments based on clinical-molecular phenotypes. Prednisone dosing starts based on weight and is gradually tapered over the study. During the study, participants undergo evaluations including effectiveness rates at 6 and 12 months, relapse rates, safety monitoring, hormone dosage tracking, vascular imaging, and cytokine profile changes. Patient-reported outcomes like pain scores, quality of life surveys, and fatigue assessments are also collected. The study includes monitoring for adverse events and continues follow-up through the full 14-month period to assess long-term treatment effects and disease control.

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.

Takayasu arteritis is a rare, chronic inflammation of the large arteries such as the aorta and its main branches. This condition can cause narrowing, blockage, or stretching of these vessels, sometimes leading to aneurysms. It often affects young Asian women and may remain undetected until vascular problems arise. Because many people with Takayasu arteritis show no clear symptoms despite active disease, researchers are seeking new biomarkers to improve diagnosis and monitor disease activity, aiming to better understand its underlying biological processes. This observational study focuses on identifying these biomarkers by enrolling individuals diagnosed with or suspected of having Takayasu arteritis. Participants include cases who meet specific classification criteria and controls. The study collects data retrospectively and prospectively, using imaging techniques like vascular magnetic resonance angiography or computed tomography angiography instead of traditional angiography. The study monitors disease status over time to uncover biochemical markers linked to disease activity. Participants will have their diagnosis and disease activity recorded from medical records within about three to six months after sample collection. These records and follow-up visits help assess the progression and activity of the disease. The study involves reviewing clinical data and imaging results to support biomarker discovery. Participation duration and follow-up depend on individual cases, with researchers closely tracking disease status to enhance understanding of Takayasu arteritis.

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.

Takayasu arteritis is a chronic inflammation of large blood vessels, mainly affecting the aorta and its main branches. This research focuses on evaluating the outcomes of stopping biologic treatments in patients who have maintained long-term remission using these therapies. The study aims to understand how safe it is to discontinue biologic drugs like tumor necrosis factor inhibitors and tocilizumab after at least three years of use in patients with stable disease. Participants will undergo a specific 3-month dose tapering of their biologic medication. If they do not experience a relapse during this tapering phase, they will completely stop the biologic treatment. After stopping, patients will be followed for 12 months to monitor their health. Clinical and laboratory assessments will be done one month after stopping treatment and then every three months. Imaging tests will be done as needed based on clinical evaluations. Throughout the study, researchers will measure how many patients maintain remission 12 months after stopping biologic therapy. They will also track the rate and timing of disease relapse during both the tapering and follow-up periods. Additional analyses will explore factors that might predict relapse and differences related to the type of biologic agent used or other treatments. The total participation includes the tapering period plus a year of follow-up to closely observe patient outcomes.