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 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.

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 treatments 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.

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.

Researchers are evaluating the dose-effect relationship of TQH3906 capsules compared to placebo in treating active Psoriatic Arthritis PsA. This Phase II, randomized, double-blind, placebo- and active drug-controlled clinical trial aims to measure the proportion of participants achieving a 20% improvement in arthritis symptoms by Week 12, using the American College of Rheumatology ACR20 criteria as the primary endpoint. Participants are randomly assigned to receive one of several oral treatments daily from Day 1 to Day 85 either 24 mg or 16 mg of TQH3906 capsules, placebo capsules matching TQH3906, or 5 mg tofacitinib citrate tablets. The treatments are administered in the morning while fasting, with tofacitinib also taken at bedtime. This study evaluates efficacy and safety across these groups over 12 weeks of treatment. During the study, participants are assessed at multiple timepoints for improvements in arthritis symptoms ACR20, ACR50, ACR70 and psoriasis severity PASI 75 and PASI 90. Blood samples are collected to evaluate drug levels and immune markers at baseline and Weeks 2, 4, 8, and 12. Safety is monitored continuously through adverse event reporting up to 28 days after the last dose. The total study duration per participant is approximately 12 weeks of treatment plus follow-up.

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 injections in children with moderately to severely active ulcerative colitis, Crohns disease, or juvenile psoriatic arthritis. This Phase 3 study focuses on pediatric participants who have previously been treated with guselkumab and will continue therapy in this extension study to monitor safety over an extended period. Participants who completed dosing in one of three primary pediatric guselkumab studies and are deemed by their investigator to benefit from continued treatment will join this long-term extension. Guselkumab is administered as a subcutaneous injection either every 8 weeks or every 4 weeks, depending on prior study assignment and clinical status. Some participants may switch dosing frequency once during the extension before unblinding, after which dosing aligns with their original regimen. Dose adjustments are restricted based on the primary study they came from. During the study, participants will receive guselkumab injections regularly and be monitored for treatment-emergent adverse events for up to nearly seven years. Researchers will assess safety outcomes through ongoing clinical evaluations over this time. Parents or legal representatives provide consent for children to participate, and children capable of understanding the study will give assent. The total participation duration may extend up to six years and nine months, allowing long-term safety data collection.

Researchers are studying 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 divided into two parts Part A includes both children and teenagers, while Part B includes only children. Initially, only teenagers who meet the study requirements can participate, with children joining after sufficient information is collected from other studies. Participants in Part A will be randomly assigned to receive either zasocitinib or a matching placebo daily for the first 16 weeks, followed by open-label zasocitinib treatment until the study ends. In Part B, all children will receive zasocitinib throughout the study. The treatment doses for children will be based on their weight, and adolescents will receive a fixed dose. The study lasts up to 4 years and 2 months, including screening, treatment, and safety follow-up periods. During the study, participants will visit the study site multiple times for assessments. Researchers will measure improvements in skin condition using tools like the Static Physicians Global Assessment and Psoriasis Area and Severity Index at Week 16 and throughout the open-label period. Safety and drug levels in the body will also be monitored. After treatment, there is a 4-week safety follow-up. Overall, participants will be involved for up to 217 weeks, including screening, treatment, and follow-up.