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Axial Spondyloarthritis clinical trials

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NCT ID: NCT05779969 Recruiting - Clinical trials for Axial Spondyloarthritis

Comparison of CT Scan Between Patients With Axial Spondyloarthritis and Control Subjects

SPA-THORAX
Start date: February 9, 2023
Phase:
Study type: Observational

The aim of this study is to define structural damage to the manubriosternal joint (MST) in axial spondyloarthritis (axSpA) by comparing its CT scan aspects between a population of patients with radiographic (axSpA) and a control population free of chronic inflammatory rheumatism.

NCT ID: NCT05676775 Recruiting - Clinical trials for Axial Spondyloarthritis

British Axial Spondyloarthritis Inception Cohort

BAxSIC
Start date: June 9, 2023
Phase:
Study type: Observational

The British Axial Spondyloarthritis Cohort (BAxSIC) study has been established under the auspices of the British Society for Spondyloarthritis (BRITSpA) in collaboration with the National Axial Spondyloarthritis Society (NASS) to provide real-world data to evaluate the impact of delay in diagnosis (from symptom onset to diagnosis) on work participation and functional outcomes and the natural history and impact of newly-diagnosed axial Spondyloarthritis, including disease activity, pain, fatigue, functional and work outcomes, comorbidities, therapies in the United Kingdom (UK). The study is a prospective cohort, enrolling patients attending rheumatology clinics in the UK who are newly diagnosed with axial Spondyloarthritis and naïve to biologic therapy. The study will run for an initial 3 year period commencing January 2023. Financial support was provided as a Research Grant from Pfizer Limited, UCB and Novartis.

NCT ID: NCT05654753 Recruiting - Clinical trials for Axial Spondyloarthritis

The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment

FMT-SpA
Start date: March 28, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Current pharmacological management of inflammatory rheumatism and in particular axial SpA remains imperfect. Only 50% of patients respond to the most effective biotherapies, and many of them are only partially relieved. In addition, these are extremely expensive treatments that expose them to the risk of potentially serious side effects. Compelling evidence indicates that gut dybiosis could be a critical trigger of inflammation in axial SpA and thus correcting dysbiosis represents an attractive way of reversing the pathogenic process.The efficacy of FMT in patients with axial SpA has never been studied. This randomized double-blind study will be the first to assess feasability of FMT in axial SpA, the capacity of this procedure to restore healthy microbiome, its tolerance and its potential efficacy on disease activity. If sucessfull, this trial would set the path to larger-scale clinical trials of FMT to treat axial SpA. Two-co primary objectives in a hierarchical design: - to evaluate the capacity of FMT to correct dysbiosis in active axial SpA despite well-conducted phamacological treatment by replacing pre-existing dysbiotic microbiota with healthier microbiota. - to explore the efficacy of FMT versus placebo on clinical evolution of SpA.

NCT ID: NCT05622708 Recruiting - Clinical trials for Non-radiographic Axial Spondyloarthritis

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

Start date: March 28, 2023
Phase: Phase 4
Study type: Interventional

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.

NCT ID: NCT05504616 Recruiting - Clinical trials for Axial Spondyloarthritis

Health Technology to Improve Exercise in axSpA

Start date: July 21, 2022
Phase: N/A
Study type: Interventional

Despite the known benefits of physical activity, the majority of Canadians fail to meet recommended guidelines. Patients with axial spondyloarthritis (axSpA) also fail to meet recommended guidelines. Exercise, a critical component of physical activity, is considered the cornerstone of axSpA management. Simple health technologies such as mobile phone messaging and email can be useful tools to increase engagement in regular physical activity among the general public and patients with chronic disease. As such, the aim of this research project is to develop and test a patient-centered strategy that provides education on the importance of physical activity and utilizes existing health technologies (such as smart phone applications) to encourage regular participation in physical activity. The results of this study are expected to demonstrate that patients with axSpA will increase their daily engagement in physical activity, and therefore improve symptoms, function and overall quality of life.

NCT ID: NCT05450133 Recruiting - Clinical trials for Ankylosing Spondylitis

Hematological Parameters in Axial Spondyloarthritis

Start date: July 15, 2022
Phase:
Study type: Observational

Axial spondyloarthritis is an inflammatory disease characterized by the involvement of the sacroiliac joints and the spine. Disease activity and structural changes are determined by using physical examination, imaging studies, laboratory parameters, and patient-reported indices. Among laboratory studies, Erythrocyte sedimentation rate (ESR) and c-reactive protein (CRP) are the most commonly utilized parameters. However, the level of ESR and CRP are inadequate in demonstrating disease activity and inflammation compared to other diseases. In this study, the investigators aimed to analyze and compare the systemic inflammatory index (SII), which is a hematologic parameter between subjects with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, and healthy controls. Secondarily, the relationship between disease activity and enthesitis score and SII scores in patients with radiographic and non-radiographic axial spondyloarthritis will be investigated.

NCT ID: NCT05433168 Recruiting - Spondyloarthritis Clinical Trials

Study Evaluating the Effectiveness of Shiatsu on Fatigue in Patients With Axial Spondyloarthritis

SFASPA
Start date: September 20, 2022
Phase: N/A
Study type: Interventional

Spondyloarthritis is a potentially serious disease with reduced life expectancy. Even if the clinical presentation is eminently variable from one patient to another, the most frequently encountered manifestations such as inflammatory spinal pain, peripheral arthritis or even extra-articular involvement of the disease all represent disabling symptoms, origin of pain, temporary or in some cases permanent functional incapacity, but also general repercussions on daily life (asthenia, reactive depressive syndrome, etc.) which require a multidisciplinary approach, involving several medical, paramedical and other stakeholders, The objective of treatment is to improve quality of life, to control symptoms and inflammation, to prevent structural damage, particularly in peripheral damage, to preserve or restore functional capacities, autonomy and social participation of patients with spondyloarthritis. In France, the main professional reference for shiatsu is the Syndicat des Professionnels de Shiatsu, which proposes the following definition to define shiatsu: Shiatsu (finger pressure in Japanese) is an energetic manual discipline addressing the individual as a whole. Shiatsu is part of personal assistance. He receives himself, dressed in soft clothes. Shiatsu is a discipline of well-being and prevention for better health. Its objective is to correct both the energy flow (ki, blood, lymph, etc.) and the body structure (muscles, tendons, etc.) by applying rhythmic pressure to the whole body, most often with the inches. It is for everyone and at all ages. Its principle of action is to restore the free flow of Ki (qi, Energy) in the body. Shiatsu is a set of pressures performed mainly with the thumbs and the palms of the hands on different areas of the body, often taking up the points of the acupuncture meridians. Shiatsu pressures can be (Ishizuka 1993; Kagotani 1984; Okamoto 2016): - mobile in a given place and lasting 3 to 5 seconds: a phase of increasing pressure followed by a short holding time then release, - static: same phases but with a hold time of up to approximately 1 minute or even longer. To date, there is no treatment specifically targeting fatigue in axSpA. Indeed, the underlying mechanisms of fatigue in SpA remain poorly understood, and could for example involve pro-inflammatory cytokines and the inflammatory process, and/or psychological distress. The effectiveness of non-pharmacological interventions and in particular the care provided by shiatsu practitioners have not been the subject of studies evaluating, according to the criteria of evidence-based medicine, the benefit of this practice, particularly in the context of treatment of spondyloarthritis.

NCT ID: NCT05290363 Recruiting - Spondyloarthritis Clinical Trials

The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis

SpA23
Start date: October 6, 2022
Phase: N/A
Study type: Interventional

This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a bicentric, non randomized prospective study aiming to better understand the mechanisms of the response to anti-IL-23 biologics in Spondyloarthritis patients attending the rheumatology department of hospital Cochin and Saint Antoine (APHP).

NCT ID: NCT05244109 Recruiting - Clinical trials for Axial Spondyloarthritis

Biomedicines and Bacterial Translocation in Spondyloarthritis

TEARE-BIO
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The aim of this project is to evaluate the effect of anti-TNF and anti-IL17 biotherapies on bacterial translocation in patients with NSAID-resistant axial spondyloarthritis.

NCT ID: NCT05094128 Recruiting - Clinical trials for Axial Spondylarthritis (r-axSpA)

A Study to Assess Disease Activity in Adult Participants With Axial Spondyloarthritis Who Receive Upadacitinib in a Real-world Setting

UpSPINE
Start date: November 22, 2021
Phase:
Study type: Observational

Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain that might be difficult to distinguish from other causes of chronic back pain. Many participants report persistent pain, including back pain, which impacts disease activity and and impairs quality of life while evoking typical disease burden such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained disease control, and the association between pain and clinical/patient-reported outcomes in axSpA participants. Upadacitinib is being developed for the treatment of axSpA. Approximately 352 adult participants with active axSpA will be enrolled in Germany. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 52 weeks. There may be a higher burden for participants in this study compared to usual standard of care due to study procedures. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.