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Spondylitis, Ankylosing clinical trials

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NCT ID: NCT05589922 Completed - Clinical trials for Ankylosing Spondylitis

The Relationship Between Abnormal Modified Schober Index and Demographic Characteristics and Clinical Variables

Start date: October 24, 2022
Phase:
Study type: Observational

This study will aim to compare ankylosing spondylitis (AS) participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur

NCT ID: NCT05570656 Completed - Clinical trials for Ankylosing Spondylitis

Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers

TELESPA
Start date: December 13, 2022
Phase: N/A
Study type: Interventional

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that mainly affects the spine and pelvis in its axial form. It is responsible for chronic inflammatory pain and sometimes ankylosis with significant functional retention. Clinicians need markers capable of precisely measuring the restriction of range of motion in these patients, reflections of the activity and/or sequelae of the disease. The Inverstigators validated movement markers in the AS by a device including inertial sensors (XSENS) and computer modeling. The accuracy and repeatability of the XSENS-Awinda system compared to the reference measurement system have been demonstrated. The XSENS-Awinda device offers new real-time evaluation possibilities for quantitative gait analysis. This opens the way to new diagnostic tools, prognostics and therapeutic perspectives for the clinician.

NCT ID: NCT05527444 Active, not recruiting - Clinical trials for Ankylosing Spondylitis

The Clinical Efficacy and the Changes of Immune Cells Subsets With Bioagents in Ankylosing Spondylitis Patients

Start date: March 15, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the clinical efficacy, safety and immunological changes of secukinumab(sec) compared to adalimumab(ada) in patients with active ankylosing spondylitis(AS), who previously have an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or bioagents.

NCT ID: NCT05467995 Completed - Clinical trials for Ankylosing Spondylitis

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

Start date: June 2, 2021
Phase: Phase 2
Study type: Interventional

This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of AK111 in subjects with active ankylosing spondylitis.

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: NCT05429801 Completed - Clinical trials for Ankylosing Spondylitis

Ozone Therapy in Ankylosing Spondylitis

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the effects of rectal ozone therapy added to medical treatment on pain severity, disease activity, spinal mobility, functional status, enthesitis, and quality of life (QoL) in patients with ankylosing spondylitis (AS). Patients and methods: Patients who fulfilled the modified New York criteria for AS were included in this randomized controlled study. Thirty patients selected according to inclusion and exclusion criteria were randomized into two groups. Rectal ozone treatment along with medical treatment was administered to the patients in group 1, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks. The patients in group 2 continued only their current medical treatment. All patients received a comprehensive rheumatologic assessment including pain severity, disease-specific instruments for disease activity, functional status, spinal mobility, enthesitis score, and QoL.

NCT ID: NCT05427942 Recruiting - Clinical trials for Rheumatoid Arthritis

Yuflyma® (Adalimumab), Patient Experience After Switching

YU-MATTER
Start date: June 3, 2022
Phase:
Study type: Observational

Patient preference and experience can impact patients' adherence and persistence regarding a treatment, especially when switching. A number of factors contribute to this, including their beliefs, fears, expectations, and overall knowledge. This is compounded by the fact that many switched patients are not trained on how to use the new injection device. Specifically, some patients report a degraded experience with current adalimumab biosimilars (40mg/0.8mL) as compared to the originator: injections appear more painful and seem to cause more bruising. Indeed, treatment-related factors such as treatment volume or the presence of citrate have the potential to negatively impact patient experience and contribute to local reactions at or around the injection site, such as pain and swelling. Yuflyma® (CT-P17 adalimumab), developed by Celltrion Inc., is a biosimilar of the anti-TNF treatment adalimumab, having obtained a marketing authorisation from the European Commission on 11th February 2021 (addressed to Celltrion Healthcare). Yuflyma® is the first high-concentration adalimumab biosimilar (40mg/0.4mL) available in France, which makes the product similar to the currently available adalimumab originator formula in terms of drug concentration. Studying patient experience over the course of a switch involves querying patients at the time of prescription, while they are still under the previous treatment, and for the following 3 months, during which they have been able to pick up their prescribed medication from a pharmacy and have started using the new treatment. Describing patient experience over the course of a switch from another adalimumab (originator or biosimilar) to Yuflyma® would contribute to identifying significant factors which contribute to patient experience and satisfaction. Our primary objective is to assess patients' overall satisfaction with the injection after the switch to the high-concentration adalimumab biosimilar Yuflyma®, at 3 months following the initiation, compared to their experience with the previous adalimumab. - Overall satisfaction with the injection (7-level likert) before initiation - Overall satisfaction with the injection (7-level likert) 3 months after initiation

NCT ID: NCT05407246 Completed - Clinical trials for Active Ankylosing Spondylitis

Phase II Study of Hemay005 in Patients With Active Ankylosing Spondylitis

Start date: August 5, 2022
Phase: Phase 2
Study type: Interventional

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study. The study was divided into three stages, including screening period(4-week), treatment period(16-week) and observation period. All subjects need to enter a 28 day (4-week) observation period after stopping hemay005 treatment. Main purpose: The efficacy of hemay005 tablet in the treatment of active ankylosing spondylitis (as) was evaluated by placebo parallel control. Secondary purpose: - To evaluate the safety of oral hemay005 tablets in patients with active as. - To evaluate the population pharmacokinetics of hemay005 tablets in patients with active as.

NCT ID: NCT05379049 Recruiting - Clinical trials for Rheumatoid Arthritis

Therapeutic Response to Tumor Necrosis Factor-alpha (TNF-alpha) Antagonists in Rheumatoid Arthritis.

TNF-alpha
Start date: March 1, 2022
Phase:
Study type: Observational

Rheumatoid arthritis (RA) is an autoimmune, chronic inflammatory disease and TNF-alpha has been recognized as a triggering cytokine in the induction of joints inflammation and is involved in the pathogenesis of RA. Treatment for RA aims to reduce disease activity, prevent or manage joint deterioration and lower the risk of major comorbidities such as heart disease and stroke. The strategy of targeting cytokines has significantly increased RA patient outcomes. Therefore management with biological disease-modifying antirheumatic drugs "bDMARD" (Etanercept, Infliximab, Adalimumab) should be considered, If the treatment goal is not met with the first conventional synthetic drug modifying antirheumatic drugs (csDMARD) strategy, or if there are poor prognostic factors. The multi-biomarker disease activity test could be used to help standardise individual treatment decisions, especially in patients who failed to respond well to the traditional treatment. Iraq does not currently have specific guidelines, which might pose a risk to patients' safety. More data about the choice of bDMARD is needed in terms of tracking therapeutic response, or whether TNF or other pro-inflammatory cytokines like interleukin-6 (IL-6) is the main factor for the development and severity of RA. These data are important to improve the overall status of the patient, better choice of treatment and biomarkers to detect. There is limited information on the treatment patterns of rheumatoid arthritis (RA) across Iraq including the Kurdistan Region. Therefore, the aim of this research is to evaluate the efficacy, and clinical responses of RA patients who have been treated with different anti-TNF, as well as on answering the research hypothesis, Can plasma TNF-alpha and IL-6 be used as markers of therapeutic response to TNF alpha antagonist in patients with RA?

NCT ID: NCT05303285 Recruiting - Clinical trials for Ankylosing Spondylitis (AS)

A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis

Start date: June 14, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of secukinumab 300mg in Chinese adults participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).