Clinical Research Directory

Study of the Association Between Sacroiliitis/Axial Spondylarthritis and Giant Cell Arteritis/ Polymyalgia Rheumatica

The purpose of the study is to recruit as many patients as possible presenting with sacroiliitis or authentic axial spondylarthritis and giant cell arteritis. The investigators will also be interested in the association of spondylarthritis and polymyalgia rheumatica given the continuum between these two pathologies. The aim is to investigate whether there is an association between giant cell arteritis and spondylarthritis or polymyalgia rheumatica and spondylarthritis.

EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases

Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases (ICARDs) encompass cardiovascular involvement in connective tissue diseases, vasculitis, and primary inflammatory cardiac processes affecting all layers of the heart. ICARDs are associated with increased cardiovascular morbidity and mortality, independently of traditional risk factors, via multiple pathophysiological mechanisms. Diagnosis and prognosis are challenged by the heterogeneity of clinical presentations. Multimodality cardiovascular imaging - including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, and positron emission tomography (PET) - plays a central role in detecting and characterizing inflammatory involvement, and may offer prognostic insights. Given the limited data on the diagnostic and prognostic utility of these imaging modalities in ICARDs, the EACVI-INFLAME study aims to assess the prevalence of confirmed cardiovascular involvement in patients with suspected or established ICARDs undergoing CMR and/or cardiac PET in a multicentric international cohort.

Effects of a Digital Exercise Intervention on Sleep and Physical Activity in Patients With Spondyloarthritis

The goal of this clinical trial is to assess whether a tailored digital Adapted Physical Activity (APA) program can improve physical activity levels and sleep quality in adults diagnosed with spondyloarthritis (SpA). The main questions it aims to answer are: Does participation in a 6-month digital APA program increase average daily step count (measured with an activity tracker)? Does the program improve sleep quality (measured with the Pittsburgh Sleep Quality Index)? Researchers will compare participants receiving general physical activity advice (control group) to those following a structured digital APA program (intervention group) to see if the tailored digital support leads to better outcomes. Participants will: Complete baseline assessments including physical activity, sleep, pain, and quality of life measures. Be randomly assigned to a control group or intervention group. For the intervention group, follow an individualized exercise program delivered through a virtual platform with support from an APA professional over 10 virtual sessions. Wear a connected activity tracker (Withings) to monitor physical activity throughout the study. Complete follow-up assessments at 6 and 12 months.

Spondylo-arthritis Screening Tool Among Patient Suffering From Inflammatory Bowel Disease

The QUESAM study aims to translate into French and validate the traduction of 2 screening questionnaires for spondylo-arthritis among people with inflammatory bowel disease. DETAIL (DETection of Arthritis in Inflammatory boweL diseases) and IBIS-Q (Inflammatory Bowel disease Identification of Spondyloarthritis Questionnaire) questionnaires are built to determine which patients might benefit from a rheumatologic consultation, for a potential rheumatologic inflammatory disease. The investigators will translate the 2 questionnaire in french thanks to an external translation company, from english to french, then back to english to make sure the translation is correct. Then, the main question is: is there a conceptual and semantic equivalence beetween the original english questionnaire and the french-translated one. Participant will answer the 2 screening questionnaire, one initial time during a consultation, and a second time after 1 month.

Core Stabilization Training in Juvenile Spondyloarthropathy

Core stabilization exercises developed by McGill have been shown to be one of the physiotherapy techniques aimed at reducing pain, increasing aerobic capacity, enhancing muscle strength, and thereby improving bone health in children with JIA. However, there is no study that has investigated core stabilization training for different types of JIA. In our study, we aim to compare the effectiveness of core stabilization training and a daily physical activity program in children with spondyloarthropathy, to help identify the most effective strategy for clinical practice. Additionally, highlighting the specific effects of core stabilization training on the treatment of juvenile spondyloarthropathy (pain, functional status, fatigue, and quality of life) will make a significant contribution to the literature. Taking into account the gaps in the literature, our study will investigate the effect of core stabilization training on pain, functional status, fatigue, and quality of life in patients with juvenile spondyloarthropathy.

Observational Prospective Turkish Inception Cohort of Uveitis and Spondyloarthritis

Spondyloarthritis (SpA) encompasses a group of inflammatory rheumatic diseases characterized by axial and/or peripheral arthritis, along with extra-articular manifestations such as enthesitis, dactylitis, uveitis, and skin lesions. Axial spondyloarthritis (axSpA), the hallmark of which is chronic sacroiliitis, can progress to vertebral fusion ("bamboo spine") in advanced cases. The prevalence of axSpA varies globally, ranging from 0.1% to 1.4%, with a higher incidence in men and a typical onset in the second or third decades of life. Diagnostic approaches include imaging techniques such as sacroiliac MRI and radiographs, alongside clinical criteria like inflammatory back pain, NSAID responsiveness, peripheral arthritis, and HLA-B27 positivity. Disease management primarily involves NSAIDs, with biologics used for refractory cases, and disease activity is monitored using indices such as BASDAI and ASDAS. Acute anterior uveitis (AAU) is the most common extra-articular manifestation of SpA, particularly associated with HLA-B27 positivity. It often presents unilaterally with redness, pain, and photophobia but can lead to severe complications if inadequately treated. Around 50% of patients with HLA-B27-positive AAU have underlying SpA, and the prevalence of uveitis increases with longer disease duration. While the link between SpA and AAU is well-established, further research is needed to determine optimal systemic treatment and follow-up protocols. This study aims to assess the prevalence and clinical characteristics of SpA in patients presenting with AAU at ophthalmology clinics.

Assessment of Cardiorespiratory Fitness in Spondylarthritis

Spondyloarthritis is a chronic inflammatory joint disease that affects the spine and sacroiliac joints. Most untreated patients eventually experience impaired mobility of the spine, pain and reduced physical function. Exercise is a cornerstone in the treatment of patients with spondylarthritis and it has been shown that high intensity exercise is just as effective in reducing disease activity as immunosuppressive medication. Additionally, patients with spondylarthritis have increased risk of cardiovascular disease both due to traditionally risk factors (obesity, high blood pressure etc) but also due to chronic inflammation. A maximal cardiopulmonary exercise test (CPET) is a measure of cardiorespiratory fitness that can be used to show progression of the exercise and which also is correlated to all-cause mortality and life expectancy. The investigators will validate an indirect maximal CPET against the gold standard with direct gas exchange measurements in patients with spondylarthritis. The indirect test is less time consuming, requires less sophisticated equipment, has lesser requirements to test personnel and facilities, and has less expenditures than the direct test. With a validated indirect maximal CPET the test of cardiorespiratory fitness will be more accessible for patients with spondylarthritis both in-hospital but also municipal.

Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases

The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results. The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.

axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis

People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients. In this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.

Calprotectine in Spondyloarthritis

To date, there are no biomarkers in spondyloarthritis that can differentiate between spondyloarthritis and fibromyalgia or other pathologies. Fecal calprotectin is a biomarker that is increasingly used in inflammatory diseases of the digestive tract. A growing interest in this biomarker is emerging in rheumatology, several publications have focused on its interest in rheumatoid arthritis, highlighting an association between serum calprotectin levels and disease activity. In spondyloarthritis, a few studies seem to show that it could be a marker of disease activity. Although a 2012 study found no difference in serum calprotectin levels between subjects with spondyloarthritis and controls. Still others have shown that it could be a predictive factor of radiological evolution in the same disease key. These data support, despite the questionable results of the Klingberg study, the value of this dosage in spondyloarthritis. The objective of this work is to show that this assay could be useful to differentiate spondyloarthritis from other pathologies with similar clinical presentation such as fibromyalgia. Difficulties classically encountered in common practice in rheumatology

Towards Telemonitoring in Immune-Mediated Inflammatory Diseases: Implementation of a Mixed Attention Model (IMIDOC)

The main objective is to evaluate the implementation of a hybrid care model called the mixed attention model (MAM) in clinical practice and to evaluate whether its implementation improves clinical outcomes compared to conventional follow-up. This is a multicenter prospective observational study involving 360 patients with rheumatoid arthritis (RA) and Spondylarthritis (SpA) from five Spanish Hospitals. Patients will be followed-up by the MAM protocol, which is a care model that incorporates the use of digital tool consisting of a mobile application (App) that patients can use at home and that professionals can review asynchronously to detect incidents and to follow their patients; clinical evolution between face-to-face visits. Another group of patients, whose follow-up will be conducted in accordance with a traditional face-to-face care model, will be assessed as the control group. Sociodemographic characteristics, treatments, laboratory parameters, assessment of tender and swollen joints, visual analogue scale for pain and electronic patient reported outcome reports (ePROs) will be collected for all subjects. In the MAM group, these items will be self-assessed both by the mobile App and during face-to-face visits with rheumatologist, who will do the same for patients included in the traditional care model. Patients will be able to report any incidence related to their disease or treatment through the mobile App.

IL17 Rate and Spondyloarthritis

There are, to date, no validated biomarkers or head-to-head RCTs of biologics to guide choice of biologic agent in axSpA. While there are now two head-to-head studies of a TNF inhibitor (TNFi) vs an IL-17 inhibitor (IL-17i) in psoriatic arthritis. Recommendations refers to biological DMARDs (bDMARDs) including TNFi and IL-17i for patients with high disease activity despite the use (or intolerance/contraindication) of at least two non-steroidal anti-inflammatory drugs (NSAIDs) in axial SpA (axSpA) and in failure of a strategy including methotrexate for psoriatic arthritis. A tool to help us to decide which bDMARDs to use is necessary. In SpA, the method of determination of IL17 seems to be questionable. The determination of cytokines after stimulation of immune cells in patients with active SpA requiring a biological treatment could provide us with a tool to assist in the choice of therapy. The aim of the study was to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment. And secondly, to show the predictive character of this expression on the therapeutic response at three months after the implementation of a biological treatment.