Psoriatic Arthritis

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 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 effectiveness of a drug called D-2570 for adults with moderate to severe plaque psoriasis. This randomized, double-blind, placebo- and active-controlled clinical trial is conducted across multiple centers and includes patients aged 18 to 70 years. The study aims to compare different doses of D-2570 with placebo and another drug, BMS-986165, to understand how well D-2570 works and its safety profile. Participants will receive different doses of D-2570, BMS-986165, or a placebo tablet. The treatment period lasts 16 weeks after enrollment. Throughout the study, both participants and investigators remain unaware of which treatment is given to ensure unbiased results. Blood samples will be collected at scheduled times for pharmacokinetic and pharmacodynamic analysis to monitor how the drug behaves in the body. During the study, participants will attend regular visits for safety and efficacy assessments, including physical exams and laboratory tests such as blood chemistry and urinalysis. The main outcome measured is the treatment's impact on plaque psoriasis over 16 weeks, with safety monitored through an average of 28 weeks until study completion. Participants will also have a safety follow-up after treatment ends to support ongoing monitoring throughout the study duration.

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.

Researchers are evaluating a digital, personalized exercise program designed to reduce disease activity in adults recently diagnosed with axial spondyloarthritis (axSpA). This controlled trial assesses whether remote exercise supervision through the SPARK app, combined with patient education videos, can improve health outcomes. The study compares this approach to usual care in patients who have not used biologic disease modifying anti-rheumatic drugs and who have active disease. Participants will be randomly assigned to one of two groups: one receiving a personalized exercise program with remote coaching and another receiving usual care. The exercise program includes high intensity interval training (HIIT), muscular strength exercises, and moderate aerobic activity spread over three days per week, with the goal of 20 minutes of HIIT weekly at 85-95% of maximal heart rate. The program is remotely delivered via the SPARK application, with weekly coaching sessions and exercise data tracked by a sports watch. Throughout the 6-month trial, participants undergo assessments including disease activity measures like ASDAS and BASDAI, physical fitness tests, psychological wellbeing scales, and safety evaluations with physical exams and MRI scans. Medication use and adverse events are also monitored. The primary outcome is disease activity at 3 months, with further evaluations at 6 months to measure the effects of the exercise intervention on health, wellbeing, and physical function.

Researchers are evaluating the long-term safety of subcutaneous guselkumab in children with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. This study includes pediatric participants who have previously received guselkumab in primary studies and aims to monitor adverse events over an extended period. Participants who completed one of three primary pediatric guselkumab studies may join this long-term extension study if the investigator believes they will benefit from continued therapy. Guselkumab is given as a subcutaneous injection every 8 or 4 weeks, depending on the dosing regimen from the original study. Some participants have an option to adjust dosing frequency once during the extension, while others continue with their original schedule without changes. During the study, participants will have regular safety assessments focusing on treatment-emergent adverse events for up to nearly 7 years. Consent from parents or legal representatives and assent from children able to understand the study are required. Researchers will monitor participants closely, collecting data on safety and tolerability while allowing continued access to guselkumab throughout the extension period.

Researchers are evaluating how well the medicine zasocitinib works, how safe it is, and how children and teenagers aged 4 to under 18 with moderate-to-severe plaque psoriasis respond to it. The study is a Phase 3 trial that includes two parts: Part A with both children and teenagers, and Part B with only children. Initially, only teenagers who meet the study rules can participate, and children may join once enough information from other studies is available. Participants in Part A will be randomly assigned to receive either zasocitinib or a placebo for the first 16 weeks, after which all participants will receive zasocitinib for the remainder of the study. Participants in Part B will receive zasocitinib throughout the study. Dosages are given orally once daily, with doses adjusted by weight for children aged 4 to under 12 years, and a fixed dose for teenagers aged 12 to under 18 years. The study includes a double-blind placebo-controlled period followed by an open-label period. Participants will be involved for up to 4 years and 2 months, including up to 35 days for screening, 208 weeks of treatment, and a 4-week safety follow-up. During this time, participants will visit the study site multiple times for assessments, including skin evaluations, quality of life questionnaires, and blood tests to monitor drug levels and safety. Researchers will measure how many participants achieve clear or almost clear skin, improvements in psoriasis severity scores, quality of life improvements, and monitor the medicine's concentration in the body.

Axial spondyloarthritis (axSpa) is a chronic autoimmune disease affecting the back, causing pain, reduced function, and lower quality of life. Despite treatments like biological agents, only about 25% of patients reach remission. Physical activity plays an important role in controlling the disease, but daily movement patterns are not yet tracked in clinical practice. This study aims to analyze how different types, frequencies, and intensities of movement affect disease control and to develop clear movement recommendations for patients with axSpa. This is a monocentric longitudinal observational study where 50 participants with axSpa will be monitored over 6 months. Movement, physical activity, heart rate, and heart rate variability data are collected continuously using an AppleWatch SE smartwatch paired with a specially designed study app on the participant's own iPhone. Every two weeks, patients complete surveys about disease activity, pain, and function. Patients visit the clinic every 3 months for physical exams and assessments. Data from the smartwatch and surveys will be analyzed to create specific movement recommendations. Participants will wear the smartwatch and use the app to track activity and report symptoms throughout the 6-month study. Clinical visits occur every 3 months for examinations and medical history updates. Researchers measure outcomes such as daily steps, training and standing time, average heart rate, heart rate variability, pain levels, and disease activity. The goal is to provide concrete advice on movement to help manage axSpa symptoms, prevent flares, and improve recovery. The total participation time is 6 months with data collected continuously and surveys completed biweekly.

Researchers are investigating personalized precision medicine for adults aged 18 to 75 with psoriasis or psoriatic arthritis. This multi-center randomized clinical trial compares a prescreen strategy-based biologics selection using immune cell biomarkers versus standard guideline-based biologics treatment. The study also explores cardiovascular biomarkers to understand disease impact and treatment effects. Participants are randomly assigned to one of two groups: a strategic group where biologics are selected based on individual immune cell screening and biomarker scores, and a standard group receiving biologics per current guidelines without prescreening. Biologics studied include adalimumab, etanercept, certolizumab pegol, golimumab, ustekinumab, secukinumab, ixekizumab, bimekizumab, and brodalumab. Blood samples are cultured to analyze cytokine responses, with follow-up visits scheduled at multiple intervals up to 72 weeks, extending up to 3 years if needed. Participants undergo clinical assessments including Psoriasis Area and Severity Index (PASI), joint counts, Disease Activity in Psoriatic Arthritis (DAPSA) score, Dermatology Life Quality Index (DLQI), and body surface area affected. Cardiovascular health is monitored by measuring internal carotid artery thickness at 6 months, 1 year, and 2 years. Researchers also collect data on pruritus and cytokine levels to evaluate treatment effects. Safety and efficacy outcomes are assessed regularly throughout the study period, with extended follow-up for up to 5 years.