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Behcet Syndrome clinical trials

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NCT ID: NCT06451575 Recruiting - Behçet Disease Clinical Trials

Thrombophilia and Thrombosis in Behçet's Disease

Start date: June 1, 2023
Phase:
Study type: Observational

Behçet's disease (BD) is a systemic vasculitis of unknown cause, affecting mainly young adults. Vasculopathy has been reported in 16.8-51.5% of cases. Genetic, infectious factors, environmental factors, presence of autoantibodies, endothelial pathologies and hypercoagulability are responsible for the etiopathogenesis of BD. The main involvements responsible for morbidity and mortality in Behçet's disease are ocular, major cardiovascular and neurological involvements. Although there is an increased thrombotic risk in the etiopathogenesis of Behçet's disease, the cellular and molecular mechanisms are not fully understood. Although endothelial dysfunction due to inflammation has been shown to be the primary cause of vascular damage in Behçet's disease, some clinical evidence suggests that hypercoagulable states also contribute to thrombosis. The most common form of vascular involvement in Behçet's disease is deep vein thrombosis in the lower extremities. Arterial occlusion mostly affects the subclavian and pulmonary arteries. Although arterial involvement is rarer than venous involvement in Behçet's disease, morbidity and mortality are higher than venous involvement. Although an increased thrombotic risk is mentioned in the etiopathogenesis of Behçet's disease, it is still controversial whether vasculitis or susceptibility to hypercoagulability plays a role in the pathogenesis of venous thrombosis. In addition, there are very few studies in the literature in which all thrombophilic parameters were analysed. Again, there is no recent study on this subject. The aim of our study is to determine the risk of hypercoagulability in Behçet's disease patients with vascular involvement, which has a highly mortal course.

NCT ID: NCT06384391 Recruiting - Clinical trials for Intestinal Behcet Disease

Intestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Treatment of Intestinal Behcet's Disease

Start date: April 30, 2024
Phase:
Study type: Observational

Background: The "treat-to-target" approach has recently been adopted in the treatment of inflammatory bowel disease (IBD). The basic premise is to define specific measurable targets and then adjust treatment until these targets are achieved and maintained. According to the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)-Ⅱ statement published in 2021, the long-term treatment targets for IBD are clinical remission, endoscopic healing, absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers were determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth. While endoscopic examination assesses the mucosal inflammatory status of the bowel wall, transmural inflammatory status needs to be evaluated with ultrasound, computed tomography (CT), or magnetic resonance enterography (MRE). Ultrasound is advantageous as it does not utilize ionizing radiation and is less costly and uncomfortable for patients, allowing more frequent use. Recent studies suggest that intestinal ultrasound is beneficial in treatment response assessment and planning in patients with Crohn's disease and ulcerative colitis. However, there is a paucity of study regarding the effectiveness of intestinal ultrasound in management of intestinal Behcet's disease. Furthermore, despite its accuracy and comprehensive imaging capabilities without radiation risk, MRE has not been widely used in the diagnosis and follow-up of the patients with intestinal Behcet's disease, and no studies have reported changes in MRE findings after treatment.

NCT ID: NCT06145893 Recruiting - Behçet's Disease Clinical Trials

A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease

Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with an equal randomization among the Hemay005 high dose, lower dose and placebo treatment groups. After subject randomization, each subject will enter an core-treatment Phase for 12 weeks following an extended-treatment phase for another 40 weeks and a follow up phase for 4weeks.

NCT ID: NCT06026020 Recruiting - Clinical trials for Behcet's Syndrome, Intestinal Type

Pathogenesis of Intestinal Behcet's Syndrome

Start date: September 2023
Phase:
Study type: Observational

There is a direct interaction between food, intestinal flora and the intestinal barrier composed of intestinal epithelial cells and mucosal immunity, whose composition and functional alterations are theorized to be closely related to the development of gastrointestinal (GI) involvement in Behcet's syndrome (BS) patients. Therefore, this study focuses on the population of patients with intestinal BS and explores the unique mechanisms leading to intestinal involvement in BS patients in terms of the characteristics of intestinal microecology. Since oral ulcers are one of the most common clinical manifestations in BS patients, in addition to intestinal flora analysis, this application project also plans to collect saliva samples from patients in the hope of obtaining a holistic understanding of mucosal flora in different parts of the entire GI tract. Serological testing and analysis will also be performed, focusing on changes in the intestinal tract and serum IgE levels, and analyzed in conjunction with microbiomics to provide evidence to further elucidate the pathogenesis of BS and GI involvement, and to search for more efficient therapeutic strategies, in terms of a variety of aspects, including clinical manifestations and disease progression.

NCT ID: NCT05999461 Recruiting - Clinical trials for Behcet's Disease With Multisystem Involvement

Association of Auditory Dysfunction With Retinal Ischemia in Behcet Disease

Start date: September 2, 2023
Phase:
Study type: Observational

Auditory dysfunction is commonly detected in Behçet's disease (BD). Also, vestibular abnormalities as well as cochlear function affection have been found. The inflammatory process in BD may be the cause of audiometry abnormalities in those patients. The aim of this study is to assess hearing dysfunction in Behçet patients and its relation to retinal ischemia and disease activity using conventional pure-tone audiometry (cPTA), tympanogram and acoustic reflex

NCT ID: NCT05904301 Recruiting - Clinical trials for Rheumatoid Arthritis

Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases

NAREG
Start date: June 21, 2023
Phase:
Study type: Observational

Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.

NCT ID: NCT05879419 Recruiting - Clinical trials for Rheumatoid Arthritis

Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases

RZVRheum
Start date: May 23, 2023
Phase: Phase 4
Study type: Interventional

Introduction: Patients with autoimmune rheumatic diseases (ARDs), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PAs), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), primary Sjögren's syndrome (pSS) , systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM) and primary vasculitides, have a high risk of herpes zoster (HZ) infection. This increased susceptibility is caused by a deficient cell-mediated immune response due to the underlying disease and glucocorticoid and immunosuppressive treatments that impair the T-cell response, including conventional and unconventional synthetic disease-modifying anti-rheumatic drugs (DMARDs) and biological agents. In this context, the recent availability of a recombinant vaccine against HZ (RZV or Shingrix®), composed of recombinant VZV glycoprotein E (gE) and the AS01B adjuvant system (HZ/su), is a major progress regarding safety for immunosuppressed patients. Its effectiveness, however, has been clearly demonstrated for non-immunosuppressed patients and in selected populations of immunocompromised individuals. There are no prospective controlled studies evaluating the immunogenicity of RZV and its impact on the activity of the underlying disease, as well as its safety in patients with ARDs at high-risk for HZ. Hypothesis: RZV has a good safety profile, including with respect to underlying rheumatic disease activity, in patients with ARDs at high risk of HZ. Objectives: Primary: To assess the short-term safety profile in relation to underlying disease activity in patients with ARDs at high risk of HZ immunized with RZV compared to unvaccinated patients. Secondary: To evaluate the general safety of the vaccine in patients with ARDs at high risk of HZ immunized with RZV and non-immunosuppressed control subjects (CG); the humoral and cellular immunogenicity of RZV in patients with ARDs at high risk of HZ compared to CG; the influence of disease treatment on vaccine response; the 12-month persistence of humoral immunogenicity and incident cases of HZ. Specific studies will also be carried out to evaluate the effect of drug withdrawal (methotrexate-MTX and mycophenolate mofetil-MMF) after vaccination in increasing the immune response in patients with ARDs with controlled underlying disease.

NCT ID: NCT05767047 Recruiting - Clinical trials for Juvenile Psoriatic Arthritis

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Start date: March 23, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety of apremilast in participants 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.

NCT ID: NCT05683626 Recruiting - Uveitis Clinical Trials

Safety and Efficacy of Adalimumab Therapy for Treatment of Behcet's Disease-related Uveitis in Sohag University Hospital

Start date: December 15, 2022
Phase:
Study type: Observational [Patient Registry]

the goal of this prospective cohort study is to asses the Safety and efficacy of Adalimumab therapy for treatment of Behcet's disease-related uveitis in adult patients at sohag university hospital. Patients will receive adalimumab (40 IU), subcutaneous injection every two weeks for 6 months either as a primary treatment or if refractory to corticosteroids and at least one conventional synthetic immunosuppressive drug.

NCT ID: NCT05635266 Recruiting - Stroke Clinical Trials

Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives

Start date: October 26, 2021
Phase:
Study type: Observational

To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.