Clinical Research Directory

SLAMF1 Gene Expression in Ankylosing Spondylitis

This cross-sectional study aims to evaluate SLAMF1 gene expression levels in patients with ankylosing spondylitis compared with healthy controls.

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.

2 Years Prospective Study to Collect Real-life Data on the Retention, Quality of Life, Effectiveness and Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis

This was an observational, prospective primary data collection study. The duration of observation was 2 years after study enrolment date. Disease and treatment history were retrospectively reviewed from medical record at enrollment with no time limits for the key diagnosis of enrolment (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthropathy).

Nurse-Led Exercise Program for Older Adults With Ankylosing Spondylitis

This study evaluated whether a nurse-led tailored exercise program improves spinal mobility, functional ability, pain, and health literacy in adults aged 60 years or older with ankylosing spondylitis. Participants received five individual sessions over 2 weeks covering disease education, neck, shoulder, back, trunk, pelvic, lower-limb, and breathing exercises, and posture during daily activities, followed by home practice with telephone follow-up. Outcomes were assessed before the program and approximately 3 months after it.

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

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.

A Randomized Trial of Ultrasound-Guided Acupotomy for Ankylosing Spondylitis

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.

Surface Topography and Radiographic Spinal Damage in Radiographic Axial Spondyloarthritis

Radiographic axial spondyloarthritis (r-axSpA) causes progressive structural damage of the spine, conventionally quantified on lateral cervical and lumbar radiographs using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Repeated radiography entails cumulative radiation exposure, substantial inter-reader variability and low sensitivity in early disease. DIERS Formetric 4D surface topography provides radiation-free three-dimensional modelling of the spine and pelvis. The association between sagittal balance and structural damage has been demonstrated with a radiation-based system (EOS), but whether a radiation-free topographic method reflects the same association has not been investigated. This single-centre, cross-sectional observational study will enrol 53 adults with r-axSpA fulfilling the ASAS criteria with radiographic sacroiliitis according to the modified New York criteria. At a single study visit, static DIERS Formetric 4D measurements, chest expansion, BASMI, BASDAI, BASFI and ASDAS-CRP are obtained. mSASSS is scored by two independent readers, blinded to clinical and topographic data, on existing lateral cervical and lumbar radiographs obtained within the preceding 12 months; no additional radiographs are performed for the study. The primary analysis is the correlation between total mSASSS and the DIERS fleche cervicale (cervical sagittal anterior displacement).

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

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).

Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)

The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.

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).

Lacticaseibacillus Rhamnosus GG Supplementation in Active Ankylosing Spondylitis

The goal of this clinical trial was to learn whether Lacticaseibacillus rhamnosus GG supplementation improves disease activity, physical function, and inflammatory markers in adults with active ankylosing spondylitis. The main questions it aimed to answer were: Does Lacticaseibacillus rhamnosus GG supplementation reduce disease activity and improve physical function, as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI)? Does Lacticaseibacillus rhamnosus GG supplementation reduce C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)? Researchers compared Lacticaseibacillus rhamnosus GG supplementation with a placebo (an identical capsule containing no active ingredient) to determine whether probiotic supplementation provides additional benefits in adults with active ankylosing spondylitis. Participants: Took one capsule containing Lacticaseibacillus rhamnosus GG (6 × 10⁹ colony-forming units) or an identical placebo capsule once daily immediately after a meal for 8 weeks. Continued their existing pharmacological treatment without changes during the study. Attended study visits at baseline and every 15 days during the 8-week study period. Had disease activity, physical function, CRP, and ESR assessed at baseline and at the end of week 8. Had dietary intake, anthropometric measurements, and body composition assessed during the study.

Wet Cupping Therapy in Ankylosing Spondylitis

This study evaluates the efficacy of wet cupping therapy in patients with ankylosing spondylitis.Wet cupping therapy will be applied to half of the patients plus routine pharmaceutical treatment while the other half will receive only pharmaceutics

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

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 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 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).

Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients

This observational study aims to assess the frequency and severity of Meibomian Gland Dysfunction (MGD) and associated ocular surface changes in patients with systemic autoimmune rheumatic diseases compared with healthy volunteers. Meibomian glands are specialized glands in the eyelids that produce the lipid layer of tears, preventing tear evaporation. Systemic inflammation in rheumatologic conditions may affect these glands, leading to dry eye symptoms and ocular surface damage. A total of 150 participants (120 rheumatologic patients and 30 healthy controls) will be evaluated in a single cross-sectional examination. Rheumatologic diagnoses include Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, and Psoriatic Arthritis. Participants will undergo a standardized series of non-invasive and minimally invasive eye examinations, including: * An ocular symptom questionnaire (Ocular Surface Disease Index) * Non-contact infrared meibography to assess meibomian gland loss (Meiboscore) * Non-invasive tear break-up time (NIBUT) and tear meniscus height measurements * Slit-lamp biomicroscopy and corneal fluorescein staining The study also examines how meibomian gland alterations correlate with systemic disease activity scores and inflammatory blood markers.

Study to Assess Change in Disease Activity and Adverse Events of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan

Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis \[AS\]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. This study will assess how effective Rinvoq is in treating axSpA. Rinvoq is an approved drug for treating axSpA. Approximately 100 adult participants who are prescribed Rinvoq by their physician in accordance with local label will be enrolled in Japan. Participants will receive Rinvoq as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

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.

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.

Fecal Microbiota Transplantation in Axial Spondyloarthritis

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.

15-Hydroxyprostaglandin Dehydrogenase in Osteoarthritis and Ankylosing Spondylitis

To evaluate serum and synovial fluid 15-PGDH levels in patients with osteoarthritis and ankylosing spondylitis and determine their associations with clinical and musculoskeletal ultrasound features. To compare 15-PGDH concentrations among patients with knee osteoarthritis, and ankylosing spondylitis with knee effusion To evaluate whether serum 15-PGDH reflects intra-articular 15-PGDH concentrations. Analysis the level of 15-PGDH in relation to disease activity and severity of both diseases.

A Study to Assess the Safety of Subcutaneous Secukinumab for Treatment in Adult Indian Participants With Axial Spondyloarthritis (axSpA), Ankylosing Spondylitis (AS), and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

The aim of this study is to assess the safety of secukinumab in Indian adult participants with axSpA, AS, and nr-axSpA over a 16-week treatment period. The present study is being undertaken to fulfill the Post Marketing Surveillance (PMS) mandate by the Health Authority (HA) to evaluate the safety of secukinumab solution for injection administered subcutaneously in a pre-filled pen in the indicated population under real-world clinical practice conditions.

Evaluation of Serum IL-41 Level in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

Psoriatic arthritis (PsA) and ankylosing spondylitis (AS) are chronic inflammatory diseases within the spectrum of spondyloarthritis, characterized by immune-mediated inflammation and progressive functional impairment. Meteorin-like protein (Metrnl) is a novel adipomyokine with potential immunomodulatory and anti-inflammatory properties; however, its role in spondyloarthritis remains incompletely understood. This study aims to evaluate serum Metrnl levels in patients with PsA and AS compared with healthy controls and to investigate their association with disease activity, inflammatory markers, and clinical manifestations. The findings may provide insights into the potential role of Metrnl as a biomarker of disease activity and inflammation in spondyloarthritis.