Spondylitis

The 100-Year Human Aging Study is a long-term observational research project enrolling adult participants to undergo detailed multi-system health screenings and follow them throughout their lives until death. The study aims to identify which health measurements taken at enrollment and repeatedly over time can predict overall mortality, cause-specific death, serious diseases, and functional disability. It addresses the current lack of validated longevity measures by generating data on how various physiological and cognitive functions relate to aging outcomes. Participants undergo a comprehensive clinical screening that includes tests of cardiorespiratory fitness, strength, mobility, neurocognitive performance, sensory functions, and metabolic health. Structural imaging assessments like DEXA scans, echocardiography, electrocardiography, spirometry, retinal photography, and vascular ultrasound are performed. Laboratory tests and detailed medical, social, and environmental histories are also collected. The study allows participation from single tests up to a full two-visit screening, with repeat testing encouraged to track health changes over time. Throughout the study, participants receive individualized reports with investigational estimates of biological age and predicted mortality risks, which are being evaluated against actual health outcomes. Researchers collect data continuously on mortality, disease occurrence, disability, and health behavior changes. The study involves ongoing follow-up with periodic assessments and aims to preserve all collected data for future analyses, with participant involvement potentially spanning their entire lifespan.

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 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 participants 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 conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of AOC 1044, also known as delpacibart zotadirsen, for treating Duchenne Muscular Dystrophy DMD in boys aged 7 to 16 with specific gene mutations suitable for exon 44 skipping. This study is designed as a randomized, double-blind, placebo-controlled trial to assess the impact of this intravenous treatment on muscle function over time. Participants will be randomly assigned to receive either AOC 1044 or a placebo infusion every 6 weeks for 54 weeks, totaling 9 doses during the double-blind treatment period. After this, all participants can join an open-label extension where they receive AOC 1044 every 6 weeks for another 54 weeks, adding 9 more doses. Following the final dose at week 102, participants will have assessments at weeks 108 and 114 to evaluate safety and treatment effects. During the study, participants will undergo various assessments including tests for time to rise velocity, muscle strength, walking and climbing abilities, and quality of life measures. Muscle enzyme levels and global impressions of severity and change from both patients and caregivers will also be monitored. Safety and tolerability will be reviewed regularly by an independent committee. Overall participation lasts over two years, including screening, treatment, extension, and follow-up phases.

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.

This research focuses on breastfeeding mothers who are receiving bimekizumab, a treatment for conditions such as moderate to severe plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa. The study aims to measure the amount of bimekizumab present in mature human breast milk. It is a phase 1, open-label study sponsored by UCB Biopharma SRL, designed to understand drug exposure through breastfeeding. Participants are women who continue to receive commercially available bimekizumab as prescribed by their physicians. They will be monitored while breastfeeding, with breast milk samples collected on multiple days spanning from Day 1 to Day 57. The study does not alter their treatment but observes the concentration of bimekizumab in breast milk during this sampling period. Throughout the study, researchers will collect breast milk samples on specified days to assess bimekizumab levels and estimate infant exposure. Safety will be monitored by recording any treatment-emergent adverse events in the mothers from the time of consent through follow-up. The total duration of active sampling and monitoring extends to approximately 17 weeks, during which mothers will be observed under the care of their treating physicians.

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 drugs 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.