Ankylosing Spondylitis

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 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.

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.

This research investigates the effects of IL-17 inhibitors on subclinical enthesitis in adults with moderate to severe psoriasis. The study is observational, prospective, and open-label, aiming to assess the safety and effectiveness of these inhibitors using Power Doppler Ultrasonography (PDUS) to detect enthesitis. It focuses on patients with inflammatory changes at peripheral attachment points, which are not yet clinically apparent. Participants will receive IL-17 inhibitor treatment as part of routine care, with study evaluations occurring over a 52-week period. The primary outcome is the change in the Glasgow Ultrasound Enthesitis Scoring System (GUESS) from baseline to week 24. Secondary outcomes include changes in GUESS at various time points, resolution of enthesitis, bone changes, skin assessments, pain scores, and progression to psoriatic arthritis. Throughout the study, participants will undergo ultrasound assessments and clinical evaluations at multiple visits up to week 52. Researchers will monitor skin and joint symptoms, pain levels, and structural changes using various scoring tools. Safety and treatment effects will be tracked prospectively, with participant involvement lasting approximately one year.

Researchers are studying the experiences of people who develop rheumatic immune-related adverse events (irAEs) after receiving immune checkpoint inhibitor immunotherapy. This study aims to understand how severe these events are, how they affect daily function, and the attitudes of patients towards different aspects of these side effects. The research focuses on conditions like arthritis and polymyalgia rheumatica that arise following this cancer treatment. This observational study does not involve any drug or treatment interventions. Instead, it gathers information through qualitative assessments from patients diagnosed by rheumatologists with inflammatory arthritis or polymyalgia rheumatica as irAEs after immune checkpoint inhibitor therapy. The study is sponsored by M.D. Anderson Cancer Center and will collect data over about one year. Participants will engage in interviews to share their experiences, which will help researchers evaluate the safety and adverse events associated with these immune-related conditions. The study includes monitoring adverse events throughout the study period. The total involvement duration averages one year, allowing for comprehensive understanding of the impact and progression of these rheumatic irAEs.

Researchers are evaluating the efficacy and safety of Jitongning tablets in adults with active axial spondyloarthritis (ax-SpA). The study aims to determine if Jitongning tablets can improve symptoms and functions better than a placebo. It also assesses the safety of the tablets in this patient population. The trial is a randomized, double-blind, placebo-controlled Phase III study sponsored by Tasly Pharmaceutical Group Co., Ltd.

Researchers are studying the concentration of bimekizumab, a medication used for conditions like moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa, in mature breast milk from mothers receiving this treatment. This phase 1 study aims to understand how much of this drug is present in breast milk to inform safety and care decisions for breastfeeding mothers. The study involves breastfeeding mothers who are already receiving commercial bimekizumab as prescribed by their doctors. Participants will continue their treatment as usual while the research team collects breast milk samples on multiple days throughout the study, including days 1, 2, 3, 5, 7, 9, 11, 13, 15, 29, and 57, to measure bimekizumab levels. The study is open-label and prospective, meaning participants and researchers know the treatment being taken. During the study, participants will provide breast milk samples at specified times, and researchers will estimate the infant's dosage and relative intake of bimekizumab from breastfeeding. The study will also monitor any treatment-emergent adverse events for the mother from consent through about 17 weeks. Participation requires ongoing breastfeeding and continuing treatment, with careful monitoring throughout the sampling period and follow-up safety contact.

Researchers are studying the effects and safety of a drug called 608 in people with non-radiographic axial spondyloarthritis (nr-axSpA), a type of inflammatory spine condition. This phase II clinical trial aims to compare 608 with a placebo to see how well it works and how tolerable it is for patients. The study is sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. and follows strict protocols to assess treatment outcomes. Participants are randomly assigned to one of three groups: two groups receive different doses of 608 by subcutaneous injection, and the third group receives a placebo injection. The study is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment. The main treatment period lasts 16 weeks, during which the drug's effects on symptoms and inflammation are measured. During the trial, participants will attend regular visits for assessments including clinical evaluations and blood tests to measure drug levels and inflammation markers. The primary measure is the percentage of participants achieving a 40% improvement on the Assessment of Spondylo Arthritis International Society (ASAS) criteria by week 16. Secondary measures include a 20% improvement on ASAS criteria and drug concentration in the blood up to week 24. Safety and tolerability are closely monitored throughout the study, which is expected to conclude by November 2025.

Researchers are evaluating the efficacy and safety of LNK01001 in adults with active ankylosing spondylitis, a chronic inflammatory disease affecting the spine. This Phase 3 clinical trial aims to assess how well LNK01001 works compared to a placebo in improving disease symptoms and activity. The study includes participants who have active disease despite prior treatment with nonsteroidal anti-inflammatory drugs (NSAIDs). Participants are randomly assigned to one of two groups during a 16-week double-blind period: one group receives LNK01001 12 mg orally twice daily, while the other receives a matching placebo twice daily. After 16 weeks, all participants enter a 36-week open-label extension in which those initially on placebo switch to LNK01001 at the same dose. This design allows researchers to compare initial responses and gather long-term safety and efficacy data. Throughout the study, participants will have regular assessments including evaluations of disease activity using the Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Other assessments include disease activity scores, pain ratings, functional indices, and quality of life questionnaires. Safety will be monitored continuously. The total participation duration is 52 weeks, with close follow-up to understand how the treatment affects symptoms and function over time.