Spondylitis

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 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.

Childhood obesity is a growing public health issue worldwide and especially in Spain, where it is more prevalent in southern regions. Factors contributing to this include dietary habits, physical inactivity, socioeconomic status, and family environment. The study aims to evaluate the impact of a nutritional intervention administered by school nurses to address childhood obesity and its health consequences, including heart and musculoskeletal issues. The study compares two groups of schoolchildren aged 6 to 16. One group receives a technological intervention using podcasts, gamification, and virtual reality to promote nutrition education and healthy behaviors. The control group receives traditional brochures with nutritional information. Both groups are monitored through various measurements and biometric data collected over a 15-month period. Participants will be assessed regularly for weight, height, body composition, circumference measures, blood pressure, and adherence to the Mediterranean diet using questionnaires. Additional evaluations include a 3D avatar system for anthropometric measures. The study includes data collection at multiple timepoints from 12 weeks up to 15 months, with ongoing monitoring to assess the effectiveness of the intervention and potential health improvements.

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.

Researchers are evaluating the efficacy and safety of the drug 608 in adult patients with active ankylosing spondylitis (AS). The trial aims to demonstrate the clinical efficacy of 608 at week 16 compared to placebo and to assess both safety and tolerability up to week 16, with ongoing long-term safety monitoring up to week 60. This is a phase 3, randomized, double-blind, placebo-controlled study involving adults aged 18 years and older. Participants receive either 608 or a placebo through subcutaneous injections. The treatment period includes 16 weeks to evaluate primary and secondary outcomes, followed by continued observation for safety up to week 60. The study includes a placebo control group to compare responses and assess the effect of 608 on ankylosing spondylitis symptoms. During the trial, participants undergo assessments to measure their response according to the Assessment of Spondylo Arthritis International Society (ASAS) criteria at week 16. Safety and tolerability are also closely monitored throughout the study and the extended follow-up period. The total involvement includes periodic evaluations, laboratory tests, and clinical monitoring to ensure participant safety and to measure treatment effects over time.