Temporal Arteritis (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.

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 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 conducting a multi-centre observational study to better understand giant cell arteritis (GCA) and polymyalgia rheumatica (PMR), conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.

Researchers are exploring a new way to personalize treatment for autoimmune and autoinflammatory rheumatic diseases. This study aims to develop and use a special cell-based test that helps predict how well patients will respond to disease-modifying antirheumatic drugs (DMARDs). By identifying the best treatment for each person, the study hopes to improve treatment success, shorten the time to see benefits, and lower healthcare costs. The approach focuses on analyzing immune cells from patients to better understand their response to different therapies. The study includes several groups: newly diagnosed patients without prior treatment, patients already on immunomodulatory therapy, and healthy individuals for comparison. Blood samples are collected at different times depending on the group. Researchers use advanced laboratory methods to test immune cell responses to DMARDs outside the body, measuring specific immune signals and gene activity. Archived tissue samples are also studied to link immune profiles with disease features. This design allows detailed analysis of immune function related to treatment. Participants will provide blood samples and undergo clinical assessments over time, including baseline and follow-up visits at 6 and 12 weeks, with additional optional visits if disease worsens or treatment changes. The study measures changes in immune cell types and activity using the ex vivo assay and other tests. Data are stored securely, and the study will compare predicted responses with actual clinical outcomes to validate the test's usefulness. Participants' involvement may last up to a year, with ongoing monitoring and data collection to support personalized therapy development.

Researchers are investigating whether new imaging methods can help classify giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) to better predict how patients respond to treatment, their risk of relapse, and possible complications. This study aims to use these insights to guide treatment plans, improve disease control, and reduce damage caused by the disease or its treatment. It is a national observational study focused on patients with GCA and PMR, common inflammatory conditions in older adults. Participants will be enrolled at any stage of their disease and data will be collected through a national Danish database. The study will compare steroid treatment doses between different forms of GCA and between PMR patients with or without certain vascular involvement. Imaging with FDG-PET/CT and clinical data will be collected at various visits, such as enrollment, 2 months, 6 months, annually, and at 2 years after diagnosis. Blood samples will also be collected through a clinical biobank. During the study, data entry will occur at specified visits to track disease progress and treatment response. Researchers will monitor outcomes such as cumulative steroid doses and incidence of aortic dilatation or complications over time, with assessments up to 10 years. Regular audits will ensure data quality, and linkage with national medical registries will support comprehensive analysis. Participation involves clinical assessments, imaging, and blood sample collection following Danish guidelines.