Wegener's Granulomatosis

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 PET/CT 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 PET/CT scan within four weeks after enrollment. No experimental treatments are administered since this is an observational study. Participants will undergo clinical evaluations and the PET/CT 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 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 developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

This research aims to collect data from patients with active severe ANCA-associated vasculitis (AAV), focusing on those treated with avacopan and those treated with cyclophosphamide or rituximab-based induction regimens without avacopan. The study is non-interventional, multinational, and prospective, lasting up to 7 years, including about 3 years for recruitment. Its main goal is to evaluate the incidence of specific safety events in patients starting avacopan treatment. The study will include two groups: one with approximately 250 adults treated with avacopan, and another with about 250 adults receiving standard care using cyclophosphamide or rituximab without avacopan. Patients who began treatment within 6 months prior to enrollment or those starting treatment at enrollment will be included. Follow-up visits will occur periodically during routine clinic visits until 4 years after the last patient enrolls. Participants will be monitored through routine clinical visits, where data on safety events, adverse events, and various laboratory markers will be collected. The study will assess changes over time in kidney function, immune markers, and other blood tests. Researchers will also track flare occurrences, medication use, and safety outcomes over the entire study period, which may last up to 7 years.

Researchers are evaluating the safety and effectiveness of BCMA-CD19 chimeric antigen receptor (CAR)-modified T cells in adults with multiple refractory autoimmune diseases that have not responded to other treatments. This open-label, single-center, single-arm Phase 2 study focuses on various autoimmune conditions including systemic lupus erythematosus, Sjogren syndrome, inflammatory myopathy, systemic sclerosis, Behcet's disease, ANCA-associated vasculitis, antiphospholipid syndrome, acquired thrombotic thrombocytopenic purpura, and IgG4-related disease. The study aims to assess the complete remission rate and laboratory markers as primary outcomes, along with pharmacokinetics, long-term effectiveness, and safety as secondary outcomes. Participants receive a single intravenous dose of BCMA-CD19 targeted CAR-T cells at 3×10^6 cells per kilogram of body weight, administered 1 to 2 days after preconditioning. The total volume infused ranges from approximately 10 to 70 mL. This single-dose treatment is followed by monitoring for clinical and laboratory improvements to evaluate treatment effects. The study spans up to 52 weeks depending on the specific autoimmune condition being treated. Throughout the study, participants undergo regular evaluations of clinical signs, laboratory tests, and pharmacokinetic assessments to track safety and efficacy. Outcome measures are collected from enrollment through either 24 or 52 weeks depending on the disease. Participants must adhere to stable doses of glucocorticoids and disease-modifying drugs during the trial. The study includes long-term safety monitoring and requires informed consent and contraception use for participants who may have children. Total participation lasts up to about one year from enrollment.

Researchers are studying ANCA-associated vasculitis, a group of rare and serious autoimmune diseases including granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis. The goal is to understand the disease better by collecting standardized data over several years, focusing mainly on identifying predictors of relapse and other complications like mortality, infections, cardiovascular issues, and cancer to improve patient care. Participants with ANCA-associated vasculitis will be part of a single study group undergoing various sample collections and assessments. These include blood samples, fecal samples, and urinary samples taken at the start, annually for five years, and during any relapse or treatment change. Questionnaires will also be completed at these times to gather patient-reported information. During the study, participants will be monitored for disease relapse and other health outcomes over five years. Researchers will use tools like the Birmingham Vasculitis Activity Score and Vasculitis Damage Index to assess disease activity and damage, alongside patient and physician evaluations. Safety and treatment effects, including the impact of glucocorticoids, will be tracked, with study visits involving sample collection and questionnaires to help understand disease progression and patient health over time.

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.

Researchers are conducting a multicenter retrospective observational study to identify and describe vocal cord lesions that cause dysphonia in patients with systemic autoimmune diseases. The study focuses on understanding the types of lesions, such as "bamboo nodes" and other specific or non-specific lesions, their diagnosis timing, and treatment approaches in conditions like rheumatoid arthritis, systemic lupus erythematosus, and other connective tissue diseases. The study involves reviewing medical records from January 2014 to December 2024 to characterize vocal cord lesions responsible for dysphonia. The research examines patient histories for lesions like fibrosis, immune complex deposits, rheumatoid nodules, granulomas, and other mucosal abnormalities. Treatment methods like vocal therapy, oral steroids, surgery, and avoiding irritants are noted, though management varies due to the rarity of these conditions. Participants' records will be reviewed for lesion type as diagnosed by specialists such as otorhinolaryngologists or rheumatologists. The study assesses diagnosis delays, lesion management, and associated risk factors. Participants will not undergo new treatments but will have their medical histories analyzed to better understand dysphonia causes in autoimmune disease contexts.

This research aims to better understand cutaneous vasculitis by studying skin lesions in patients with various types of idiopathic vasculitis. It involves a multi-center approach with both primary vasculitis care providers and dermatologists working together to select suitable patients and collect lesion samples for analysis. The study focuses on evaluating the histopathology and gene expression profiles (transcriptome) of these skin lesions. Participants with active vasculitis skin lesions will undergo a punch biopsy to collect tissue samples. These samples will be examined using standardized methods to assess the histopathology and transcriptomic characteristics of the cutaneous vasculitis. The study does not involve any experimental treatments but gathers detailed clinical data and biopsy specimens for analysis. Participants will be evaluated by specialists, who will collect clinical information and perform skin biopsies at affected sites. The study will review clinical data linked to biopsy samples over one year. Researchers will monitor the samples to better characterize the disease at the tissue level. The total participation time varies, with follow-up focused on the evaluation of biopsy results and clinical data.

Researchers are collecting biological and clinical data from patients with systemic autoimmune diseases to better understand these complex conditions. These diseases affect a notable portion of adults, mostly women, and involve the immune system attacking the body. The study aims to identify new biomarkers and improve diagnosis and treatment options by exploring the clinical, biological, and genetic differences among patient groups. Participants will provide blood samples during their routine diagnosis and follow-up visits, with a larger amount of blood taken specifically for this study. This observational study focuses on patients with rare systemic autoimmune diseases or atypical forms who may be undergoing innovative treatments such as new drugs, gene therapy, or cell therapy. During the study, researchers will collect biological samples and clinical data and analyze them to find new diagnostic and prognostic markers, predict relapses or treatment responses, and understand disease mechanisms. The study will monitor patients for about one year, with the goal of improving personalized medicine approaches for these autoimmune diseases.