Vasculitis

Researchers are investigating antineutrophil cytoplasmic antibody ANCA-associated vasculitis AAV, a condition where lung and kidney involvement often leads to worse outcomes. This study aims to evaluate a new PET imaging tracer, 68Ga-Fibroblast Activation Protein Inhibitor FAPI, which targets activated fibroblasts to detect disease activity and lesion distribution in AAV patients. Early and accurate diagnosis using this novel tracer could help personalize treatment and better assess disease severity and prognosis. The study will observe patients with AAV, including those with or without interstitial lung disease and renal dysfunction, using the 68Ga-FAPI PETCT scan. This noninvasive imaging technique allows whole-body disease localization in a single exam. The study will compare disease severity and activity as measured by the PETCT scan within four weeks after enrollment. No experimental treatments are administered since this is an observational study. Participants will undergo clinical evaluations and the PETCT imaging to assess disease activity and severity. Researchers will collect clinical information and imaging data to provide insights on lesion distribution and organ involvement. The study requires informed consent and cooperation throughout the process. Total participation time varies, with the primary outcome measured within four weeks post-enrollment. Safety and compliance will be monitored during the study period, which runs until July 2028.

Researchers are studying pulmonary arterial hypertension PAH, including its common subtypes idiopathic PAH IPAH and connective tissue disease-associated PAH PAH-CTD. The study aims to develop pulmonary vascular biomarker signatures using hyperpolarized 129Xe MRI to differentiate these subtypes and to evaluate the ability of this imaging to monitor disease progression and treatment response over time. Additional assessments such as laboratory tests, echocardiography, and six-minute walk distance 6MWD are also used to support these evaluations. The study is observational and enrolls 20 subjects divided into two groups 10 with IPAH and 10 with PAH-CTD. Participants will undergo hyperpolarized 129Xe MRI and MR spectroscopy at baseline, 3 months, 6 months, and 12 months. Alongside imaging, data from standard clinical assessments including labs, echocardiography, and 6MWD will be collected at these same timepoints to track changes. Participants will be monitored for changes in pulmonary vascular remodeling, red blood cell oscillation amplitude, 6MWD, NTproBNP levels, and WHO functional class over one year. Safety is assessed by tracking adverse events, serious adverse events, withdrawals, and specific examinations such as electrocardiograms and vital signs. The total follow-up period for each participant is one year, with multiple scheduled evaluations to comprehensively assess disease status and response.

Researchers are exploring the potential use of the imaging agent 68Ga Ga-FAPI in PETCT scans for diagnosing and monitoring various chronic inflammatory and fibrotic diseases. This pilot study focuses on 13 different clinical conditions such as rheumatoid arthritis, liver fibrosis, and systemic lupus to assess whether this new radiotracer can improve disease evaluation compared to current methods. The study aims to gather initial data to guide further development and possible routine use of this imaging technique in these diseases. Participants receive a 68Ga Ga-FAPI PETCT scan in addition to their usual medical care. The imaging is performed either once at baseline or longitudinally at baseline and again at 3 and 6 months if their treatment is intensified at inclusion. This approach allows researchers to observe how the radiotracer behaves in different diseases and over time, helping to refine its clinical application. During the study, participants undergo PETCT scans to measure the intensity of the PET uptake and correlate these findings with pathology evaluations, biomarkers, functional parameters, and imaging characteristics at baseline, 3 months, and 6 months. This detailed assessment helps to understand the diagnostic value of 68Ga Ga-FAPI in chronic inflammatory and fibrotic conditions. The study runs until October 2028 and is conducted at a single center, with participants followed through these imaging and clinical evaluations.

Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis RA. This study focuses on understanding two main factors influencing pain relief brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinibs impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.

Researchers are investigating the specific targets of T cells involved in autoimmune diseases by studying tissues from patients with active organ inflammation caused by autoimmune conditions. The study aims to identify which T cells are activated and expanding in diseased tissues compared to blood or normal tissues. This information will help discover new peptide targets and their associated T cell receptors TCRs to develop potential new therapies for autoimmune diseases. Participants will provide tissue samples and matched blood samples during clinical procedures such as endoscopy, arthrocentesis, lumbar puncture, skin biopsy, bronchoscopy, or surgery, depending on their autoimmune condition. The study includes several groups covering diseases like Crohns disease, ulcerative colitis, celiac disease, ankylosing spondylitis, multiple sclerosis, scleroderma, systemic sclerosis, and other autoimmune diseases. Samples may come from excess clinical materials or research-specific biopsies, with the possibility of serial sampling over time. During the study, participants will undergo standard clinical procedures with collection of additional tissue or fluid samples and companion blood draws. Researchers will analyze these samples to identify peptide targets linked to disease-reactive T cells over a period of up to three years. The study includes comprehensive assessments of tissues and blood to understand T cell activity in autoimmune disorders, with monitoring of participant safety and no interventions beyond routine clinical care.

Researchers are studying the safety and effectiveness of CAR NK cells for treating relapsed or refractory B-cell related autoimmune diseases. This early phase 1 pilot study plans to enroll 15 patients to evaluate the safety, feasibility, and potential benefits of this treatment. The study also explores how well the CAR NK cells expand, persist, and deplete B cells in these patients. Participants will receive a pre-treatment of Fludarabine and Cyclophosphamide on days -5, -4, and -3, followed by an infusion of CAR NK cells. This is a single-group, open-label trial where all participants receive the study treatment. The trial monitors patients for adverse events and dose-limiting toxicities within the first 4 weeks and up to 52 weeks after infusion. During the study, participants will be closely monitored through clinical assessments and laboratory tests at multiple time points up to one year after treatment. Researchers will measure safety outcomes including adverse events and toxicities, as well as effectiveness outcomes like disease control and remission rates. The total study duration may last up to approximately three years, including follow-up to assess long-term safety and treatment effects.

Researchers are evaluating the safety, tolerability, and initial effectiveness of CD19BCMA-targeted CAR-T cell therapy in patients with refractory autoimmune diseases. This early exploratory, open-label, single-arm clinical study focuses on adults aged 18 to 70 who have autoimmune conditions that have not responded to standard treatments. The study aims to explore whether this new in vivo CAR-T therapy approach can control disease activity without prior lymphodepletion. Participants will receive an intravenous infusion of the CD19BCMA-targeted CAR-T lentiviral vector drug. After infusion, the CAR-T cells are produced directly inside the patients body. No lymphodepleting chemotherapy will be given before treatment. Following the infusion, participants will be monitored for safety and efficacy over a 24-month period to assess disease control and treatment tolerability. During the study, participants will undergo regular safety assessments to monitor adverse events at multiple time points including Day 28, and Months 2, 3, 6, 12, 18, and 24. Researchers will track the maximum tolerated dose within 28 days after infusion. Additional evaluations will include clinical and laboratory tests to assess disease response and patient health. The total participation length can be up to two years, allowing long-term observation of treatment effects and safety.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

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 PETCT scans to diagnose GCA. Researchers aim to compare AzaFol with the standard 2-18FFDG-PETCT 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-PETCT and FDG-PETCT 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 establishing a prospective group of patients with plasma cell disorders PCDs to better understand these conditions and their treatments. This study focuses on various PCDs including multiple myeloma, amyloidosis, and other related disorders. It aims to explore how minimal residual disease MRD status relates to patient prognosis and investigate the role of the tumor microenvironment TME in the diseases development and progression. Patients with confirmed PCDs who are hospitalized and willing to participate will be followed over time. Biological samples such as peripheral blood, bone marrow aspirate, and urine will be collected before and after treatment to support future research. The study does not involve any intervention and participants will be regularly assessed at baseline, then at 1, 3, 6, and 12 months after treatment, followed by yearly visits. During the study, clinical and laboratory data along with biological samples will be gathered to analyze disease features and treatment responses. Follow-up visits will monitor patient progress and outcomes for up to ten years. The main outcome is to maintain a comprehensive cohort and understand the relationship between MRD and prognosis in PCD patients, while also supporting further studies on tumor clone evolution and disease mechanisms.