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Spondylarthritis clinical trials

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NCT ID: NCT06460805 Recruiting - Inflammation Clinical Trials

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

axSEND
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06451588 Recruiting - Clinical trials for Ankylosing Spondylitis

Fecal Microbiota Transplantation in Axial Spondyloarthritis

MicroSpA
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints. It has been established that patients with SpA have an altered composition of microorganisms (microbiota) in the gut compared to healthy controls, and that this correlates to disease activity and respons to therapy. The goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy. The main questions it aims to answer are: - Can FMT reduce disease activity in axial SpA? - Can FMT alleviate pain and reduce fatigue in axial SpA? - Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT? Participants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.

NCT ID: NCT06421116 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis

ORGANOSPA
Start date: March 7, 2024
Phase:
Study type: Observational

This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.

NCT ID: NCT06392620 Recruiting - Clinical trials for Ankylosing Spondylitis

Telerehabilitation in Ankylosing Spondylitis

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

Ankylosing Spondylitis (AS) is an inflammatory rheumatic disease primarily affecting the spine and sacroiliac joint. xercise is one of the most important nonpharmacologic treatment modalities in AS. Stretching, strengthening, aerobic, posture, balance and moltimodal exercise methods are the most commonly used treatment methods. The study will include 44 patients diagnosed with AS aged 18-65 years. Patients will be divided into two randomized controlled groups with 22 patients in each group. Group 1 will receive a personalized exercise program including stretching, strengthening, respiratory, aerobic and posture exercises via video conferencing. Group 2 will be recommended a video on the YouTube platform and will be asked to perform the exercises by following the content of these videos. Spinal mobility will be assessed with Bath Ankylosing Spondylitis Metrology Index, disease activity with Bath Ankylosing Spondylitis Disease Activity Index, function with Bath Ankylosing Spondylitis Function Index, quality of life with Ankylosing Spondylitis Quality of Life Scale and posture with PostureScreeen mobile application.

NCT ID: NCT06378697 Recruiting - Clinical trials for Ankylosing Spondylitis

A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis.

NCT ID: NCT06369324 Recruiting - Clinical trials for Ankylosing Spondylitis

Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed With Spondyloarthritis

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Spondyloarthritis, notably ankylosing spondylitis (AS), represents a chronic rheumatic condition typified by persistent back pain and stiffness. It constitutes a substantial portion of diagnoses within rheumatology units and exhibits a higher prevalence among males. Diagnosis relies upon comprehensive clinical evaluation, including patient history, physical examination, and adjunctive radiological assessments, with genetic predisposition, particularly the presence of the HLA-B27 antigen, playing a significant role. Management strategies encompass a multidisciplinary approach, with physiotherapy emerging as a cornerstone therapeutic modality. Various exercise interventions, particularly those supervised by trained professionals, demonstrate efficacy in improving pain, stiffness, and overall functional capacity. Furthermore, patient education plays a pivotal role in enhancing treatment adherence and optimizing outcomes by aligning patient expectations with therapeutic goals. The evolving landscape of spondyloarthritis management underscores the necessity of further research into multimodal treatment approaches, particularly in integrating novel interventions such as electrophysical agents. By elucidating the mechanisms of action and exploring their synergistic effects, clinicians can refine treatment protocols and ultimately enhance the quality of care provided to individuals living with spondyloarthritis.

NCT ID: NCT06299917 Recruiting - Clinical trials for Rheumatoid Arthritis

WORK-ON Vocational Rehabilitation for People With Inflammatory Arthritis

WORK-ON
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues. Based on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline.

NCT ID: NCT06287983 Recruiting - Clinical trials for Ankylosing Spondylitis

Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life.

NCT ID: NCT06259890 Recruiting - Clinical trials for Arthritis, Psoriatic

Influence of Sodium Intake in spondyLoarthriTes

SALT
Start date: January 30, 2024
Phase: N/A
Study type: Interventional

The aim of the SALT study is to analyze the relationship between dietary sodium intake and disease activity in patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis.

NCT ID: NCT06250062 Recruiting - Clinical trials for Ankylosing Spondylitis

A Clinical Study of JS005 in Patients With Ankylosing Spondylitis

Start date: January 12, 2024
Phase: Phase 2
Study type: Interventional

This is a multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis.