Clinical Research Directory

Assessment of Nutritional Status in Rheumatic Diseases and Association to Disease Activity

The aim of the present work is to assess the nutritional status among different rheumatic diseases patients and to study its association with the corresponding diseases activity.

Whole Body MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Radiographic axSpA and Non-radiographic axSpA

This study aims to further improve and expand the WB-MRI imaging evaluation cohort of axSpA patients to complete dynamic follow-up and condition assessment. Based on the WB-MRI features, the association of WB-MRI signs with disease activity, inflammation, and structural damage will be analyzed. At the same time, in-depth data mining was conducted and machine learning was used to construct a new axSpA disease activity assessment model based on WB-MRI data, and the accuracy and reliability of the model were clearly evaluated in the discovery cohort and validation cohort.

Ecological Momentary Assessment and Physical Activity in Patients With Inflammatory Rheumatic Diseases

Chronic inflammatory rheumatic diseases (IRDs), such as rheumatoid arthritis and spondyloarthritis, can cause pain, fatigue, and mobility issues, significantly impacting patients' quality of life. Physical activity is an important part of managing these conditions, as it helps reduce pain, maintain mobility, and prevent complications. However, many patients struggle to stay active due to pain and fatigue. Understanding these challenges better could lead to improved support and interventions. This study explores a new way to monitor the daily experiences of patients with IRDs using Ecological Momentary Assessment (EMA), a method that collects real-time data through a mobile app. The study will also use actimeters-wearable devices that track physical activity. Over 14 days, participants will answer short surveys on their phone and wear an actimeter to provide insights into how fatigue, pain, mood, and physical activity levels change throughout the day. Before using this approach in a larger study, we need to make sure it is practical and acceptable for patients. This pilot study will assess whether participants find the mobile app and actimeter easy to use, how often they respond to surveys, and whether frequent reminders affect their willingness to participate. The study will also examine the immediate and delayed effects of different symptoms on physical activity and explore factors that influence patient engagement with the protocol. By identifying potential barriers and solutions, this research will help refine future studies and improve the way we monitor and support people with IRDs in staying active while managing their symptoms.

COMFI - a COMbined Fatigue Intervention

Background: Inflammatory arthritis (IA) encompasses autoimmune rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is highly prevalent in people with IA with 41-57% suffering from severe fatigue. Patients describe fatigue as overwhelming, unpredictable, challenging to manage, and affecting all areas of everyday life, including the ability to work. Studies have shown that interventions with physical activity or a cognitive behavioral approach can significantly reduce fatigue severity and/or impact in people with IA compared to usual care. To date, no studies have investigated the combined effect of CBA and PA on fatigue severity and impact in patients with IA. Therefore, the goal of this study is to test the feasibility of a newly developed fatigue intervention that combines a cognitive behavioral approach and physical activity (COMFI) in patients with inflammatory arthritis, who experience fatigue as a challenge in their everyday lives in Denmark and Sweden. The intervention will be tested in 4 groups (2 in Denmark and 2 in Sweden), and the participants will participate in 7 group sessions and 2 focusgroups interview in the evaluation. The primary outcome for the participants is fatigue, measured through patient-reported outcomes at baseline, 3, 6, and 12 months after baseline. This study will show if the intervention is feasible in practice and meaningful for the participants.

AutoInflammatory Disease Alliance Registry (AIDA)

Autoinflammatory diseases (AID) are clinical entities characterized by recurrent inflammatory attacks in absence of infection, neoplasm or deregulation of the adaptive immune system. Among them, hereditary periodic syndromes, also known as monogenic AID, represent the prototype of this disease group, caused by mutations in genes involved in the regulation of innate immunity, inflammation and cell death. Based on recent experimental acquisitions in the field of monogenic AID, several immunologic disorders have been reclassified as polygenic/multifactorial AID, sharing pathogenetic and clinical features with hereditary periodic fevers. This has paved the way to new treatment targets for patients suffering from rare diseases of unknown origin, including Behçet's disease, Still disease, Schnitzler's disease, PFAPA (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) syndrome, chronic recurrent multifocal osteomyelitis (CRMO), non-infectious uveitis and scleritis. Gathering information on such rare conditions is made difficult by the small number of patients, along with the difficulty of obtaining an accurate diagnosis in non-specialized clinical settings. In this context, the AIDA project promotes international collaboration among clinical centres to develop a permanent registry aimed at collecting demographic, genetic, clinical and therapeutic data of patients affected by monogenic and polygenic AID, in order to expand the current knowledge of these rare conditions.

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

The purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease activity, improving patients' clinical symptoms and body function scores, enhancing quality of life, improving imaging performance and safety.

Bidirectional Cohort Study of Nanfang Spondyloarthritis

Spondyloarthritis（SpA） patients attending Nanfang Hospital of Southern Medical University will generate a large number of clinical condition scales, laboratory indicators, imaging data such as X-rays or MRIs in the course of multiple standardized follow-up visits, as well as medical specimens from some of the patients who undergo surgical treatments. The Department of Orthopaedic Surgery of Nanfang Hospital is looking forward to the future and proposes to establish a specialized cohort named "Nanfang SpA Bidirectional Specialized Disease Cohort" by simply recording the clinical and imaging data of the above patients who have attended the clinic, been treated routinely, and have been followed up in the department without any interventional research measures. The cohort is proposed to: (1) archive the disease characteristics, biochemical index data, and disease assessment scales of all SpA patients attending the Southern Hospital; (2) record the X-ray and magnetic resonance imaging data of the patients to establish the "Southern SpA Imaging Dataset". This provides strong support for subsequent SpA research projects and lays the foundation for subsequent large-scale transect studies and retrospective studies.

Pain in Inflammatory Joint Diseases

Our primary objective is to better understand the etiology and consequences of chronic paint by using an explorative approach to identify phenotypes and endotypes of patients with inflammatory arthritis, with a special focus on central sensitization and cognitive functioning as a key element in chronic pain. We will also examine the risk factors and clinical impact of these factors on pain, disease activity and treatment effects in a longitudinal study of patients with inflammatory joint disesases.

Vunakizumab in Adults with Spondyloarthritis

This prospective, single-arm, multicenter study is aimed to explore the efficacy and safety of Vunakizumab in adults with spondyloarthritis. The primary endpoint is the proportion of adults with spondyloarthritis achieving ankylosing spondylitis assessment score (ASAS) 40 at week 16 in the treatment of Vunakizumab.