Clinical Research Directory

Phase Ia Study of MST-931 in Healthy Adult Subjects

A Phase 1a, randomized, double-blind study of MST-931 in healthy participants. The purpose of this research is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous dose of MST-931 given to healthy participants. MST-931 is a monoclonal antibody.

Ivarmacitinib With or Without Celecoxib for Ankylosing Spondylitis

Background: Ankylosing spondylitis (AS) is a chronic, progressive inflammatory disease mainly affecting the spine and sacroiliac joints, causing pain, stiffness, structural damage, and functional disability. NSAIDs remain first-line therapy, while biologics and JAK inhibitors have expanded treatment options. However, many patients have inadequate responses or residual symptoms, and long-term combination with NSAIDs is common despite uncertain incremental benefit. Ivarmacitinib is a highly selective oral JAK1 inhibitor that has shown efficacy in active AS. Whether concomitant celecoxib adds benefit to ivarmacitinib monotherapy remains unknown. Objectives: To compare the efficacy and safety of ivarmacitinib plus celecoxib versus ivarmacitinib monotherapy in patients with active AS. The primary objective is to compare the proportion achieving an ASAS20 response at week 24. Methods: This prospective, single-center, randomized, open-label, parallel-group, active-controlled superiority trial will enroll 138 patients with active AS (BASDAI ≥4 and total back pain VAS ≥4) who had inadequate response to at least two NSAIDs or intolerance/contraindication to NSAIDs. Participants will be randomized 1:1 to ivarmacitinib 4 mg once daily plus celecoxib 200 mg twice daily or ivarmacitinib 4 mg once daily for 48 weeks, with as-needed rescue analgesia permitted. The study is open-label, but endpoint assessors and the statistician will be blinded. Key exclusion criteria include prior JAK inhibitor use, major cardiovascular events, active peptic ulcer or bleeding, moderate-to-severe renal insufficiency, pregnancy, significant laboratory abnormalities, and malignancy within 5 years. Outcomes: The primary endpoint is the proportion achieving ASAS20 at week 24. Secondary endpoints include ASAS20 at weeks 12 and 48; ASAS40 and ASAS5/6; changes in BASDAI, ASDAS-CRP, CRP, ESR, BASMI, BASFI, pain VAS, ASQoL, MASES, GUESS, and SPARCC MRI score; rescue analgesic use; and adverse event incidence, type, severity, and relatedness, with attention to gastrointestinal, cardiovascular, renal, and infectious risks. Sample Size: Assuming a week-24 ASAS20 rate of 66.7% in the combination group, a 25-percentage-point superiority margin, two-sided α = 0.05, 80% power, and 15% dropout, 69 patients per group are required (total 138). Statistical Analysis: The full analysis set includes all randomized patients receiving at least one dose, analyzed as randomized. The primary analysis will compare week-24 ASAS20 proportions using a normal-approximation Z-test with 95% CI and p-value; significance is p ≤ 0.025 one-sided. Secondary categorical endpoints will use the Z-test with non-responder imputation; continuous variables will use MMRM or ANCOVA. Safety will be analyzed descriptively in the safety set. Expected Significance: This trial will provide prospective, head-to-head evidence on whether regular celecoxib adds benefit to ivarmacitinib monotherapy, informing individualized NSAID-JAK inhibitor combination decisions and supporting evidence-based optimization of AS treatment.

Posture Exercises in Ankylosing Spondylitis

This study will evaluate the effects of posture-focused exercises on spinal alignment in patients with ankylosing spondylitis. Participants will be randomly assigned to one of two groups. The control group will receive a standard breathing exercise program. The intervention group will receive posture-focused exercises in addition to the standard breathing exercise program. The exercise program will last 8 weeks. Assessments will be performed at baseline and at the end of week 8. Spinal alignment will be evaluated using rasterstereographic analysis with the DIERS formetric 4D system. Clinical and functional outcomes will include disease activity, spinal mobility, functional status, quality of life, walking capacity, perceived exertion, and gait parameters.

Effects of Pulmonary Rehabilitation Exercises in Patients With Axial Spondyloarthritis

This prospective, randomized, single-blind controlled study evaluates the effects of pulmonary rehabilitation exercises in patients with axial spondyloarthritis. Participants were randomized into two groups. The intervention group received a pulmonary rehabilitation program in addition to conventional exercises, while the control group received conventional exercises alone. The primary outcome was pain intensity assessed using the Visual Analog Scale (VAS). Additional assessments included exercise capacity, pulmonary function, disease activity, quality of life, spinal mobility, and chest expansion. Outcomes were evaluated at baseline, week 8, and week 12.

Postural Biofeedback and Exercise in Axial Spondyloarthritis

The goal of this clinical trial is to learn whether adding a wearable postural biofeedback device to a standard exercise program affects disease activity, pain, and functional parameters in individuals with axial spondyloarthritis. The main questions it aims to answer are: Does adding postural biofeedback to a standard exercise program improve disease activity? Does adding postural biofeedback to a standard exercise program reduce pain? Does adding postural biofeedback improve functional parameters, including spinal mobility, quality of life, posture, and functional exercise capacity? Researchers will compare a standard exercise program with the same exercise program combined with a wearable postural biofeedback device to determine whether the addition of postural biofeedback provides greater benefits. Participants will: Participate in a physiotherapist-supervised standard exercise program twice a week for 8 weeks Use the wearable postural biofeedback device three days per week for at least 3 hours per day during prolonged static posture activities if assigned to the intervention group Complete assessments before and after the 8-week intervention, including measures of disease activity, pain, physical function, spinal mobility, quality of life, posture, and functional exercise capacity

An Ecological Momentary Intervention for Mental Health in Individuals With Ankylosing Spondylitis

Ankylosing spondylitis is a chronic inflammatory rheumatic disease associated with pain, stiffness, reduced mobility, and impaired quality of life. In addition to physical symptoms, individuals with ankylosing spondylitis frequently experience depression, anxiety, stress, and sleep problems. However, existing mental health support is limited and often relies on static assessments and scheduled interventions, which may not respond to patients' fluctuating daily symptoms. This study aims to develop and pilot test a WeChat-based ecological momentary intervention to improve mental health in individuals with ankylosing spondylitis in China. The study is a prospective, parallel-group, assessor-blinded pilot randomized controlled trial. A total of 36 adults with ankylosing spondylitis and mild-to-moderate depression and/or anxiety will be randomized 1:1 to either an intervention group or a control group. The intervention group will first receive six brief video-based sessions on cognitive behavioral therapy-related skills during week 1. During weeks 2 to 5, participants will use a WeChat mini-program to complete daily ecological momentary assessments of pain, depression, and anxiety. Symptom-triggered intervention modules will then provide brief, tailored strategies such as cognitive restructuring, behavioral activation, relaxation exercises, self-compassion practice, and SMART goal setting. The control group will receive standard counseling and educational materials. The primary purpose of this pilot study is to assess feasibility and acceptability, including recruitment, adherence, attrition, engagement, usability, satisfaction, and adverse events. Preliminary effects on depression, anxiety, stress, pain, insomnia, illness perceptions, coping strategies, and quality of life will also be explored at baseline, post-intervention, and 4-week follow-up.

An Investigation of the Effect of Smartphone Usage Levels on Cervical Posture, Tongue Pressure, Balance, and Neck Disability in Individuals With Rheumatoid Arthritis and Ankylosing Spondylitis

The purpose of this cross-sectional and comparative study is to investigate the impact of smartphone addiction on the cervical posture, musculoskeletal system, balance, and tongue pressure in individuals diagnosed with Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS), and to compare these findings with a healthy control group. Smartphone addiction has become a major contributing factor to postural alterations such as Text Neck Syndrome. This study aims to evaluate and compare the Craniovertebral Angle (CVA), neck extensor muscle strength, Pressure Pain Thresholds (PPT) of the neck and shoulder, Single-Leg Stance (SLS) static balance, and tongue pressure among three distinct groups. A healthy control group will be included as a reference baseline to differentiate the postural and functional deterioration caused by rheumatological diseases from the additional mechanical load imposed by smartphone dependency. To eliminate the misleading effects of acute pain, joint swelling, and severe functional limitations during flare-ups, only patients with stable disease activity (DAS28 \< 3.2 for RA and BASDAI \< 4 for AS) will be enrolled. This approach aims to examine the pure biomechanical relationship between technological dependency and cervical functions, independent of active systemic inflammation.

Efficacy of the Erector Spinae Plane Block for Persistent Back Pain in Patients With Ankylosing Spondylitis

Despite adequate control of disease activity with standard medical therapies, there remains an ongoing need for complementary and interventional approaches for the management of persistent back pain in patients with ankylosing spondylitis. Although the erector spinae plane block has been described in the literature as a safe and effective analgesic intervention for chronic back pain in various patient populations, to the best of our knowledge, no clinical study has specifically evaluated its use for persistent back pain in patients with ankylosing spondylitis receiving medical treatment. Therefore, the present study aims to evaluate the effects of erector spinae plane block on pain severity and clinical outcomes in patients with ankylosing spondylitis whose disease activity is controlled under treatment but who continue to experience persistent back pain.

Evaluation of the Expression and Functions of the KIR3DL2 Receptor and the Anti-inflammatory Activity of IPH4102 in Blood Samples

the main objectives are 1. to study the pathophysiological role of KIR3DL2 in axSpA and its relationship with Th17 immunity in HLA-B27 + and HLA-B27- patients and 2. to assess the effect on the pro-inflammatory immune response of a cytotoxic monoclonal antibody IPH4102 (anti-KIR3DL2) in these patients. The study will be carried out on blood samples from 24 patients with axSpA, 12 HLA-B27 + and 12 HLA-B27-, without any drug injection nor direct therapeutic benefit for the participating patients and 12 healthy controls.

Evaluating the Efficacy and Short-Term Prognosis of Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis(AS): A Protocol for a Cohort Study

This study is a multicenter, prospective cohort study designed to systematically evaluate the clinical efficacy of integrated Traditional Chinese and Western Medicine on short-term functional improvement in patients with ankylosing spondylitis, with the Bath Ankylosing Spondylitis Functional Index (BASFI) at 6 months of treatment as the primary outcome measure.

Oxidative Stress in Autoimmune Rheumatic Diseases

Rheumatic diseases constitute a group of non-communicable diseases characterized by chronic inflammation. The most common autoimmune rheumatic diseases (ARDs) are rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, myositis, Sjogren's syndrome and systemic scleroderma. These autoimmune disorders lead to joint destruction and adversely influence the human body systemically. One of their characteristics is comorbidity, since patients usually suffer also from other pathologies such as cardiovascular diseases and obesity. In addition, their treatment requires a combination of both biological and conventional pharmaceutical interventions as well as other parameters such as physical activity programs, nutrition, and the use of smart electronic devices. Therefore, the ARDs burden health systems worldwide. Apart from the physiological manifestations of ARDs, specific changes are observed at the cellular and molecular level. A common biochemical/molecular symptom of these diseases is oxidative stress. This condition leads to the disturbance of blood and tissue redox status due to the excessive production of free radicals. Given that free radicals are highly reactive moieties with strong oxidative capacity against biomolecules (i.e., proteins, lipids, DNA), they compromise the efficacy of the intrinsic antioxidant mechanisms and, finally, induce the disruption of redox homeostasis. However, there is no sufficient data linking the levels of redox status of patients with the progression of ARDs over time. Indeed, the onset and symptoms of ARDs are intertwined with the disruption of the patient redox homeostasis and the induction of oxidative stress. Concurrently, the absence of a completely effective pharmaceutical treatment emerges the need for the adoption of novel biomarkers for monitoring the severity of the symptoms and the evolution of ARDs in general. To that end, this study aims at first to investigate the blood redox status of patients with ARDs. Thus, specific redox biomarkers will be evaluated in the blood of patients in three time points (i.e., at Days 1, 180 and 360), and they will be associated with the clinical manifestations of their diseases. The ultimate goal is to clarify whether these biomarkers could putatively exert clinical significance, namely whether they could constitute an additional tool for the monitoring of the progression of these diseases in clinical practice.

The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study

An observational, ambispective cohort to learn about the disease progression of axial spondyloarthritis (axSpA) according to the changes from baseline in measures of disease activity, function, and imaging.

Integrated Traditional Chinese and Western Medicine for Ankylosing Spondylitis (AS): A Cohort Study Protocol Focusing on Spondyloarthritis Research Consortium of Canada (SPARCC) Scoring System

This study is a multicentre, ambidirectional, observational cohort study. The ambidirectional design incorporates both the collection of retrospective data from the three years prior to enrolment, and a prospective follow-up period of up to two years. The study is designed to evaluate the long-term effects of Integrated Medicine on radiographic progression in patients diagnosed with Ankylosing spondylitis (AS).

Deep Breathing Combined With Core Stability Exercises in the Treatment of Patients With Ankylosing Spondylitis

Exercise may be considered the gold standard for the management of mechanical and functional symptoms associated with patients having AS and they are considered as a safe and effective treatment for improving strength, spinal mobility, and physical fitness in general. However, there were no definite types or doses recommended over others. Additionally, poor posture is one of the consequences of AS due to pain, loss of flexibility, and muscular weakness which may also affect respiratory function. This faulty mechanical posture of the thoracic and cervical spine may affect the pulmonary function of these patients. Therefore, the purpose of the current study is to investigate the efficacy of deep breathing exercises added to core stability exercises in the treatment of patients suffering from AS.

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

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).

Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research

The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. "Healthy" individuals without brain inflammation are also eligible to participate. The digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.

The Effect of Exercise on Serum Irisin Levels and Clinical Parameters in Patients With Axial Spondyloarthritis.

This study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.

The Effect of Laughter Yoga on Patients With Ankylosing Spondylitis

This study will be conducted to evaluate the effects of laughter yoga on disease activity, pain, functional status, depression/anxiety/stress, and quality of life in ankylosing spondylitis patients.

The Relationship Between Arterial Stiffness and Pulmonary and Extrapulmonary Features in Ankylosing Spondylitis

The aim of this study was to investigate the relationship between arterial stiffness and pulmonary and extrapulmonary features in patients with ankylosing spondylitis.

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis

The purpose of the study is to verify the clinical feasibility of Benzathine penicillin (BPG) /Etanercept (ETN) combination regimen in patients with spondyloarthritis (SpA) and at the same time compare Benzathine penicillin /Etanercept combination regimen and Etanercept maintenance therapy in reducing disease activity, improving patients' clinical symptoms and body function scores, enhancing quality of life, improving imaging performance and safety.

Bidirectional Cohort Study of Nanfang Spondyloarthritis

Spondyloarthritis（SpA） patients attending Nanfang Hospital of Southern Medical University will generate a large number of clinical condition scales, laboratory indicators, imaging data such as X-rays or MRIs in the course of multiple standardized follow-up visits, as well as medical specimens from some of the patients who undergo surgical treatments. The Department of Orthopaedic Surgery of Nanfang Hospital is looking forward to the future and proposes to establish a specialized cohort named "Nanfang SpA Bidirectional Specialized Disease Cohort" by simply recording the clinical and imaging data of the above patients who have attended the clinic, been treated routinely, and have been followed up in the department without any interventional research measures. The cohort is proposed to: (1) archive the disease characteristics, biochemical index data, and disease assessment scales of all SpA patients attending the Southern Hospital; (2) record the X-ray and magnetic resonance imaging data of the patients to establish the "Southern SpA Imaging Dataset". This provides strong support for subsequent SpA research projects and lays the foundation for subsequent large-scale transect studies and retrospective studies.

Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases

The goal of this study is to learn if mesenchymal stem cell therapy (treatment group) can effectively treat autoimmune diseases, when compared to normal saline (given to placebo group). The primary outcome measures will be clinical improvement based on the respective disease specific clinical scores, normalization of T-lymphocyte subsets and \> 50% reduction in disease specific antibody titres. The study will also document the type and frequency of any adverse event or side effects, reported by or seen in any of the trial participants. Patients in treatment group will receive single session of MSC therapy and placebo group will receive 0.9% saline solution. The participants will be followed at 3 and 6 months.

A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.

Ankylosing spondylitis, radiographically negative axial spondyloarthritis, psoriatic arthritis, polymyalgia rheumatica, Takayasu arteritis, giant cell arteritis, non-ocular Behcet's disease, and enthesitis-related arthritis are common diseases in rheumatology. Traditional anti-rheumatic drugs are less effective and have greater side effects than biological agents. At present, there has been no large-scale registration study on rheumatic autoimmune diseases such as spondyloarthritis in China. However, data such as patient characteristics, medication patterns, and patient outcome reports of different rheumatology diseases can often serve as a reference for rheumatology clinicians to reasonably select treatment methods for different patients. Therefore, a large-scale registration study is needed to fill the gap in multi-disease registration studies in rheumatology departments in China.

Cardiovascular Disease Risk Factors and Healthy Lifestyle Behaviours in Patients with Ankylosing Spondylitis

A review of the literature did not identify any studies that assessed knowledge of cardiovascular disease risk factors and healthy lifestyle behaviours in patients with ankylosing spondylitis. The aim of this study is to assess knowledge of cardiovascular disease risk factors, healthy lifestyle behaviours and physical activity levels in patients with ankylosing spondylitis.