Clinical Research Directory

Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis

This study aims to better understand different types of low back pain in patients with ankylosing spondylitis. Low back pain is a common problem in these patients and may affect daily activities and quality of life. A total of 200 patients with ankylosing spondylitis who have had low back pain for at least three months will be included in the study. Participants will be evaluated during a single visit. The study will assess pain severity, physical function, and quality of life using standard questionnaires. It will also examine how different pain types are related to these outcomes. The results of this study may help improve the understanding of pain in ankylosing spondylitis and support better patient management.

A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps

This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis

The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.

This is an observational study to evaluate the effectiveness and safety of secukinumab in participants with AS who have never used TNFi, JAKi, or IL-17i drugs before.

Rheumatology Patient Registry and Biorepository

To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

Ankylosing Spondylitis

The goal of this observational study is to measure the serum level of cytokines IL-17, IL-38,IL-41, and gene expression of HLA-B27 gene in ankylosing spondylitis patients and healthy control group. The main question it aims to answer is: Does the disease activity, severity, serum level of cytokines (IL-17, IL-38, and IL-41) are affected by the HLA-b27 gene positivity? Researchers will compare the serum level of cytokines IL-17, IL-38,IL-41, and gene expression of HLA-B27 gene in ankylosing spondylitis patients and healthy control group to see if there significant differences in serum levels of interleukins 17, 38, 41 in AS patients and healthy control group. .

Clinical Trial Study on the Improved New Method of Acupotomy for AS

This study employs a randomized controlled trial methodology to systematically evaluate the efficacy and safety of a modified acupotomy technique in the treatment of ankylosing spondylitis. Through ultrasound-guided localization, the operative sites are assessed to clarify the improvement effect of the modified acupotomy on disease activity in AS patients. The aim is to enhance the clinical outcomes of AS, provide evidence-based medical support for acupotomy treatment of AS, and improve the diagnosis and treatment standards for the condition.

Expression of Tim-3 on Neutrophils in Ankylosing Spondylitis

1. To investigate the expression of Tim-3 on neutrophils in ankylosing spondylitis patients and its correlation with disease activity and inflammatory markers. 2. Association of Tim-3 with sacroiliac MRI findings and the hip inflammatory MRI scoring system (HIMRISS) .

Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries

Background: \- Orthopedic procedures are common in the United States. These include joint replacement and spine surgeries. Researchers want to study data about these procedures over time. They want to see if treatment has gotten better. They also want to find ways to change the care that people get before and after they have these procedures. These changes may lower the risk of problems people can have during and after treatment. They may also improve people s results. Objectives: \- To study a series of questions about surgery, medicine, treatments, and outcomes for orthopedic procedures. Eligibility: \- Data from the U.S. Centers for Medicare and Medicaid Services from 1999 to 2015. Design: * Researchers will look at data for people ages 20-100. * No new participants will be used in this study. * The study will last 6 years.

Skin Autofluorescence Assessment of Advanced Glycation End Products in Rheumatic Diseases

Rheumatic diseases are chronic inflammatory conditions that can lead to long-term tissue damage and increased cardiovascular and metabolic risk. Advanced glycation end products (AGEs) are harmful molecules that accumulate in the body over time and are known to promote inflammation and oxidative stress. Increased AGE burden has been implicated in several chronic diseases; however, its role in rheumatic diseases has not been fully clarified. This observational, cross-sectional study aims to evaluate the accumulation of AGEs in patients with various rheumatic diseases compared with healthy individuals. AGE levels will be assessed non-invasively using skin autofluorescence measurements. By comparing AGE burden between patients and healthy controls, this study seeks to improve understanding of the potential role of AGEs in the pathophysiology of rheumatic diseases and to explore their usefulness as a non-invasive biomarker in clinical practice.

Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).

Exactech Shoulder Post Market Clinical Follow-up Study

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)

This study will evaluate the efficacy and safety of 608 in patients with AS.

Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases

PURPOSE: The main purpose is to explore clinical efficacy and safety associated with capsule FMT (cFMT) performed in newly diagnosed, untreated patients with rheumatic and gastrointestinal chronic inflammatory diseases (CIDs). DESIGN AND METHODS: In this 1:1 double-blind, placebo-controlled, randomised, 12-month exploratory trial, 200 patients with at least one of 6 different diagnoses of CIDs fulfilling the study criteria will be enrolled at time of diagnosis. The patient groups are: rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), Crohn's disease (CD), and ulcerative colitis (UC). The primary endpoint is change from baseline to eight weeks in the physical component summary (PCS) of the short form health survey (SF-36). Key secondary clinical endpoints will be evaluated at 8 weeks. Other secondary clinical endpoints will be evaluated at 52 weeks and reported in secondary papers. The baseline visit will be performed as quickly as possible after the patient's informed consent has been obtained to ensure no unnecessary treatment delay. Stratified by CID diagnosis, patients will be randomised (1:1) to either placebo or single-donor cFMT processed from stool provided to the hospital from anonymous-to-the-patient healthy donors. The experimental intervention FMT/placebo will be repeated once weekly the first month (i.e., each patient will receive a total of four treatments). In addition, all participants will concomitantly be offered the national guideline first-line anti-inflammatory treatment following the baseline visit. At baseline, 8 weeks, 26 weeks, and 52 weeks a thorough clinical examination will be conducted and all relevant clinical scores for each disease entity will be registered. Patient-reported-outcomes including SF-36 and disease specific questionnaires will be collected at week 1, 2, 3, 4, 8 (primary endpoint evaluation), 26 and 52. Adverse events will be monitored through out the trial.

A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients With Autoimmune Disease

The most clinically meaningful way to discover new targets of T cells in autoimmune diseases is to study the tissues of patients with active autoimmune disease mediated organ inflammation. These tissues contain both cytotoxic and helper T cells that are driving their disease, and these T cells are being guided by TCRs that recognize tissue-specific targets. By collecting tissue when a patient has active inflammation, it is possible to determine which T cells are activated and undergoing clonal expansion in the patient's diseased organ. TScan has developed a genome-wide, high-throughput technology to determine the natural, physiological target of any TCR (Kula, 2019). The goal of this study is to isolate T cells from inflamed tissues and matched blood samples and/or matched normal tissues (for patients with inflammatory bowel diseases). T cell clones that are expanded in diseased tissues relative to blood or normal tissues will be selected and the targets of their TCRs will be defined using TScan's genome-wide, high-throughput target ID technology. The goal of this study is to discover a collection of peptide targets, along with their associated TCRs to be developed as new tolerogenic therapies for patients with autoimmune diseases.

A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis

The aim of this study is to evaluate the efficacy and safety of LNK01001 in subjects with active ankylosing spondylitis. The study is comprised of a 16-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 36-week open-label, long-term extension period (the Open-Label Extension Period). In the Double-Blind Period, participants will be randomized in a 1:1 ratio to receive either LNK01001 or placebo twice daily (BID). Participants in the placebo group will be switched to LNK01001 BID at Week 16 in the Open-Label Extension Period.

Testing of an Educational Tool for Patients With Melanoma and Pre-Existing Autoimmune Disease Who Are Candidates for Immune Checkpoint Inhibitors

This study learn how easily patients can use an educational tool that will be created for patients with melanoma and pre-existing autoimmune diseases who receive or will receive immune checkpoint inhibitor drugs. Patients will be asked their opinions about the design, accessibility, and content of the tool. Researchers will use the information collected to improve the educational materials that will help patients make future decisions about their treatment.

Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity

Social determinants of health (SDoH), defined by the World Health Organization as "the conditions in which people are born, grow, work, live and age and the wider set of forces and systems shaping the conditions of daily life" are estimated to be responsible for nearly 90 percent of a person's health outcomes. SDoH are key contributors to racial, ethnic and socioeconomic disparities in care healthcare access and health outcomes. The goal of this clinical trial is to identify patients with inflammatory arthritis or with a systemic rheumatic condition with arthritis who may respond to the simplest and least expensive intervention to address their SDoH-related needs- a tailored list of resources, those who benefit from a community-based resource specialist to help address specific needs, and those who require a nurse-trained navigator to help both coordinate the services provided by the community-based specialist, and their medical and mental health care and needs. The main questions the clinical trial aims to answer are: 1. To test the efficacy of a rheumatology clinic-based nurse navigator and community resource specialist to reduce appointment no-shows and same-day cancellations in patients with systemic rheumatic conditions with arthritis. 2. To examine the cost-effectiveness of each of the different study interventions for individuals with systemic rheumatic conditions with arthritis with SDoH-related needs using questionnaires and cost-related care metrics. Participants will be randomly assigned to 1 of 3 arms. In Arm 1, patients will receive a cultivated list of resources related to the needs that patients indicate on the social determinants of health questionnaire. Arm 1 is the control arm which receives the current standard of care. In Arm 2, patients will receive the assistance of a community resource specialist (CRS) - an individual without formal medical training with community-based expertise. In Arm 3, patients will receive the assistance of a nurse patient navigator with additional systemic rheumatic condition-specific training who will work with the CRS. After 6 months, patients who do not respond to Arm 1 will move to Arm 2. Patients who do not respond to Arm 2, will move to Arm 3. Patients who do not respond to Arm 3 will remain in Arm 3. Patients who respond to any arm will graduate the program at 6 months. The patients who do not respond be in their new arm for 6 months. At 12 months, all patients remaining in the study will graduate.

Mass Spectrometry-based Immune Profiling in Autoimmune Diseases

Based on mass spectrometry flow method, this study analyzed the typing of new T, B, NK and DC cell subsets in peripheral blood of common autoimmune diseases and their correlation with disease activity, aiming at establishing an early screening and diagnosis model of autoimmune diseases.

The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis

Subclinical intestinal inflammation and intestinal permeability have been reported in patients with ankylosing spondylitis. Gluten is one of the main triggers of zonulin releaseand gluten intake may contribute to the development of the disease by increasing intestinal permeability. This study aims to determine the impacts of a gluten-freediet on intestinal permeability, sub-clinical intestinal inflammation, disease activity, functional status and quality of life in patients with ankylosing spondylitis. The main questions it aims to answer are: Does a gluten-free diet have an effect on disease activity and functional status in patients with ankylosing spondylitis? Does a gluten-free diet have an effect on intestinal permeability and subclinical intestinal inflammation in patients with ankylosing spondylitis? The investigators will evaluate the effects of the gluten-free diet compared to a control group.

Effects of Progressive Relaxation Exercises Applied to Patients With Ankylosing Spondylitis on Pain and Fatigue Levels

Ankylosing spondylitis (AS) is a chronic rheumatic disease with unique clinical, pathophysiological, radiographic and genetic features, the etiology of which is not known for sure, and is characterized by sacroiliac and spinal joint involvement. It is reported that this disease affects one in every 200 people, is usually diagnosed years after the onset of symptoms, and negatively affects quality of life. The prevalence of AS is between 0.2% and 1.1%, and symptoms begin before the age of 30 in approximately 80% of cases. The main complaints of patients diagnosed with AS include pain, joint stiffness, fatigue, and functional limitations of various degrees. Functional limitations resulting from inflammation and/or bone formations affect daily life activities, especially the person's ability to participate in leisure and domestic activities, and work productivity, and can limit social roles in the family and society. It is reported in the literature that regular PGE reduces pain and fatigue, facilitates the transition to sleep, and improves quality of life. In this context, this study aimed to evaluate the effect of PGE in reducing pain and fatigue frequently experienced by AS patients and to contribute to symptom management.

Neuropathic Spinal Pain in Ankylosing Spondylitis

The aim of this study is to investigate prevalence of neuropathic spinal pain in AS patients and it's impact on sleep quality. Moreover effects of neuropathic pain on quality of life and fatigue will be assessed.

Ultrasound Assessment of Neck Muscles and Balance in Male Patients With Ankylosing Spondylitis

The aim of this study is to evaluate the relationship between ultrasonographic measurements of the cervical muscles and balance parameters in patients diagnosed with ankylosing spondylitis (AS)

Taekwondo for Axial Spondyloarthritis

The goal of this clinical trial is to learn if Taekwondo training works to help adults with ankylosing spondylitis and axial spondyloarthritis. It will also learn about the safety of Taekwondo training for these adults. The main questions are as follows: * Will Taekwondo training affect disease activity, functional improvement, and quality of life? * Will there be a difference between adults who participate in Taekwondo training and adults who continue with their usual treatment? * Is Taekwondo training safe for adults with ankylosing spondylitis and axial spondyloarthritis, and will it be an appropriate exercise for these adults? * Is there a possibility to develop a structured Taekwondo-based exercise program for adults with musculoskeletal disorders? Participants will: * Be a part of the Taekwondo training group or the control group for 12 weeks (where the control group will later participate in the same 12 week Taekwondo for comparison) * Be assessed within 2 weeks before the start of the training * Be assessed within 1 week after completing the training