Rheumatoid Arthritis

This research aims to determine whether supplementation with vitamin E (alpha-tocopherol) reduces inflammation and clinical activity in patients with rheumatoid arthritis (RA). RA is a common autoimmune disease causing chronic joint inflammation and potential joint damage, which leads to disability and affects quality of life. The study focuses on patients with early RA who have low vitamin E intake and are already receiving standard RA treatments. Participants will be randomly assigned to one of two groups: one group will receive conventional synthetic disease-modifying antirheumatic drugs (FARMEs) plus 800 mg per day of vitamin E, while the other group will receive the same FARMEs plus a 200 mg per day magnesium oxide placebo. The supplementation lasts for one month, with participants taking two capsules daily, one in the morning and one in the afternoon. During the study, participants will attend clinic visits at the start and end of the supplementation period for assessments including clinical activity, blood tests measuring vitamin E levels, inflammatory markers, autoantibodies, and antioxidant capacity. They will keep a diary to track symptoms and supplement intake. Researchers will evaluate changes in vitamin E levels, clinical disease activity (DAS-28), pro-inflammatory cytokines, acute phase reactants, and autoantibodies to understand the impact of vitamin E supplementation on RA.

Researchers are conducting the 100-Year Human Aging Study, an observational trial designed to follow participants over their lifespans to investigate which health measurements can predict mortality, serious diseases, and functional disability. The study aims to validate many longevity measures that currently lack prospective evidence by tracking physiological, cognitive, social, and environmental factors that change with aging. This research will generate important data to improve understanding of aging and longevity medicine. Participants undergo comprehensive multi-system clinical screenings including tests like cardiopulmonary exercise testing, body composition assessment by DEXA, echocardiography, electrocardiography, spirometry, neurocognitive testing, sensory assessments, metabolic testing, and detailed medical and social histories. The study allows for different levels of participation, from single tests to full two-visit screening batteries, and encourages repeat testing to capture health changes over time. During the study, participants receive individualized reports including investigational estimates of biological age and predicted cause of death. Researchers collect data on mortality, serious health events, chronic diseases, functional ability, and lifestyle changes through periodic follow-up over many years, potentially up to 100 years. This extensive data collection helps evaluate how well these measurements predict aging outcomes. All data are stored in raw form for future analysis and participants are supported with ongoing contact and opportunities for repeat assessments.

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 evaluating a new MRI pulse sequence called 3D DL oZTEo to detect bone erosions in the hands of patients with inflammatory arthritis. The study aims to validate this technique against current standard methods like radiography and conventional MRI, as these structural changes are important for diagnosis and treatment decisions in rheumatic conditions. This is an interventional study conducted at Mayo Clinic. Participants will have the FDA-approved oZTEo MRI pulse sequence added to their routine hand MRI scan. The oZTEo images will be anonymized and processed using a deep learning algorithm developed by GE Healthcare. This additional sequence is assessed alongside the standard MRI to compare its ability to detect bone erosions. During the study, researchers will analyze MRI scans with and without the 3D DL oZTEo sequence to determine the presence and number of bone erosions in the hand. Participants must have recent hand radiographs confirming erosions and are scheduled for hand MRI as part of their clinical care. The study measures outcomes on the day of imaging and monitors the accuracy of erosion detection.

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 Filgotinib's 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 Crohn's 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 evaluating the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed or refractory B-cell related autoimmune diseases. This early phase 1 pilot study plans to enroll 15 patients to assess the treatment's safety, feasibility, and effectiveness. The study also explores how well KN5501 expands, persists, and depletes CD19 positive B cells in these patients. Participants will receive a preparatory treatment with Fludarabine and Cyclophosphamide on three days before the infusion of anti-CD19 CAR NK cells. The trial includes two dose levels (6x10^9 and 9x10^9 cells) for dose escalation. This is a single-arm, open-label study without a placebo group. During the study, researchers will monitor participants closely for dose limiting toxicities and adverse events within the first 4 weeks and at 12, 24, 36, and 52 weeks after infusion. Effectiveness will be evaluated by disease control and remission rates at the same time points. Participants will undergo regular assessments including clinical evaluations and laboratory tests, with follow-up lasting up to one year after treatment.

Researchers are evaluating the safety and tolerability of a study medicine called MK-1045 in adults with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The study focuses on understanding how people respond to different dose levels of MK-1045. This research is sponsored by Merck Sharp & Dohme LLC and is designed as a Phase 1 clinical trial to assess safety and how the drug behaves in the body over time. Participants will receive MK-1045 through intravenous (IV) infusions. The dosing plan includes single intravenous doses at varying levels, as well as a series of three step-up doses over a three-week period, progressing from a prime dose to a target dose. The study is randomized, with participants assigned to different dosing panels to evaluate safety and drug behavior at each stage. During the study, participants will be monitored for side effects, including any adverse events and the reasons for stopping the study drug. Blood tests will measure how much MK-1045 is in the body and the effect on B cell counts at various times up to 52 weeks. Safety and drug effects are carefully tracked with follow-ups lasting up to approximately one year. Overall participation may last for several months, depending on the study part.

Researchers are investigating new ways to treat rheumatoid arthritis (RA), especially for people whose symptoms do not respond well to standard treatments like methotrexate (MTX). This study aims to evaluate a medicine called tulisokibart to see if it can reduce active RA symptoms better than a placebo. The study focuses on different doses of tulisokibart to determine which dose might be most effective while participants continue their MTX treatment. Participants will be randomly assigned to receive one of several treatments: MTX plus a high, medium, or low dose of tulisokibart, or MTX plus a placebo that looks like tulisokibart but contains no active medicine. Those on the low dose or placebo will be re-randomized at week 12 to either a medium or high dose of tulisokibart. The study includes a 12-week placebo-controlled period followed by a long-term extension lasting 116 weeks, split into a 44-week main extension and a 72-week optional extension. During the study, participants will have their RA symptoms and response to treatment assessed using criteria such as the American College of Rheumatology 20% response at week 12. Researchers will also monitor safety by recording adverse events and treatment discontinuations up to about week 142. The study involves regular evaluations, including questionnaires and clinical assessments, to track disease activity, physical function, and overall health over the entire study period.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.