Clinical Research Directory

Pain Phenotyping of Rheumatic Diseases - An Observational Study

Background: Rheumatic diseases can affect the joints, ligaments, tendons, bones, muscles, and skin. They can also cause inflammation, damage body tissues, and change nerve signals in the brain. This can lead to ongoing pain that interferes with daily life. Researchers want to know more about how pain affects the lives of those with rheumatic diseases. Objective: To learn how the body and brain experience pain in people with and without rheumatic diseases. Eligibility: People aged 9 to 85 years with a diagnosed or suspected rheumatic disease and ongoing pain. They must be enrolled in protocols 01-AR-0227, 94-AR-0066, or 11-AR-0223. Healthy volunteers are also needed. Design: All participants will have an initial visit and may have up to 5 follow-up clinic visits spaced about 6 months apart. Each visit may last 3 to 4 hours. Patients with rheumatic diseases may have up to 2 more visits if they have a disease flare-up. All participants will have these procedures at each visit: Bedside quantitative sensory testing (B-QST): The participant's body will be touched with various probes: a cotton tip, a tuning fork, an ice-cold tuning fork, a heat probe, a device that applies pressure, and a probe with a sharp tip. These probes will not cause injury. Participants will describe how the touches feel and rate the intensity on a scale of 1 to 10. Questionnaires: They will rate their overall health, quality of life, and any disease activity. Research blood: Blood will be collected during the visits. Some blood will be used for how environmental factors affect our genes. Physical exam and History review: They will provide information about their medical history and physical exam will be performed by a clinician.

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease

Background: Sjogren disease is an autoimmune disease - that is, a disease that causes the body's immune system to attack its own organs and tissues. Sjogren disease can affect the kidneys, lungs, or other organs. It can also cause dry mouth and eyes, fever, joint pain, rashes, and other symptoms. Researchers want to know if a drug approved to treat rheumatoid arthritis and other autoimmune diseases can help people with Sjogren disease. Objective: To test a drug (tofacitinib) in people with Sjogren disease. Eligibility: People aged 18 to 75 years with Sjogren disease. They must be enrolled in protocol 15-D-0051. Design: * Participants will be screened. They will have a physical exam with blood and urine tests. They will give samples of saliva; a small sample of tissue will be taken from a salivary gland. They will have a test of their heart function. They will have an eye exam, including a test for dry eyes. * Tofacitinib is a tablet taken by mouth. Participants will take the drug twice a day at home. * Participants will have 9 clinic visits over 28 weeks. Each visit will take up to 5 hours. In addition to repeated tests, they will have tests of the speed and pressure of blood flow through their body. They will complete health questionnaires throughout the study. * Participants will also have 5 phone visits during the study. They will review their health and study treatments. * They will have 1 final visit after they stop taking the drug.

Umbilical Cord Mesenchymal Stem Cell Secretome in Patients With Sjogren's Syndrome

This randomized, placebo-controlled, double-blind trial evaluated the safety and efficacy of umbilical cord mesenchymal stem cell (UC-MSC) secretome, given as an add-on to standard therapy, in women with Sjogren's syndrome. Twenty-nine participants were randomly assigned to receive six intramuscular injections of either UC-MSC secretome or 0.9% sodium chloride (placebo) over five weeks, while continuing their usual corticosteroid and/or immunosuppressant treatment. The main outcome was the change in disease activity measured by the EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI). Secondary outcomes were the inflammatory markers erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hs-CRP), and adverse events.

MYTP01 for Immune-Mediated Diseases

The goal of this study is to evaluate whether MYTP01, a traditional Chinese herbal formula developed by clinical experts with the assistance of artificial intelligence (AI), is effective and safe as an additional treatment for immune-mediated diseases (post-kidney transplantation, IgA nephropathy, etc.). The study also aims to explore whether MYTP01 may provide therapeutic benefits across these conditions by regulating shared immune and inflammatory processes. The main questions this study aims to answer are: * Does MYTP01 provide clinical benefits and remain safe when used as an additional treatment for immune-mediated conditions? * Does MYTP01 help regulate immune balance and inflammatory responses across immune-mediated disease populations? Researchers will compare MYTP01 with a matching placebo, with both treatments given in addition to standard medical care, to evaluate clinical efficacy, safety, and potential immunomodulatory effects across immune-mediated conditions. Participants will: * Be enrolled in a disease-specific cohort based on their clinical condition. * Be randomly assigned to receive either MYTP01 or placebo in addition to their usual medical treatment. * Take the assigned study treatment twice daily for 8 weeks. * Attend follow-up visits approximately once a month during a 12-week study period. * Undergo clinical assessments, blood and urine tests, and evaluations of immune function and possible side effects.

The Pathogenesis and Natural History of Sjogren's Disease

Background: -Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It is more common in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth. The cause of Sjogren s Disease is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s Disease. Objectives: -To better understand how Sjogren s Disease begins and how it affects patients so that we can develop better ways to treat them. Eligibility: * Participants must be 16 years of age or older. * They must have a diagnosis of Sjogren s Disease or have at least two symptoms of Sjogren s Disease. Design: * People taking part in the study will come to the NIH Clinical Center for at least three visits. * During these visits, participants will have a medical history and physical exam. They will have oral and dental assessments, and saliva collection. Lab tests (blood and urine) and dry eye exams will be done. Participants will answer questionnaires and have salivary scintigraphy (adults only unless required for diagnosis). * Other optional tests may also be done. Participants may have to come in for additional visits if they have these optional tests or if their disease changes. * The only treatment provided as part of this study is for medical emergencies or complications that occur while you are at NIH for evaluation....

A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

Primary Objective: To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity. Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS. 2. To evaluate the safety and tolerability of dazodalibep in participants with SS

Evaluation of Tangible Boost for Patients With Stevens Johnson Syndrome, Sjogren's Syndrome, and Graft Vs Host Disease

The goal of this research is to determine if the Tangible Boost system adequately replenishes the Hydra-PEG coating on the surface of a rigid contact lens. Hydra-PEG is a coating for soft and rigid contact lens, primarily composed of polyethylene glycol-based hydrogel, which is covalently bound to the surface of a contact lens. The Hydra-PEG coating is intended to improve wettability and comfort with contact lenses and is currently FDA approved on a number of contact lenses. For patients with Stevens Johnson Syndrome (SJS) (SS), or Graft versus Host disease (GVHD), diminished efficacy of the Hydra-PEG coating can lead to significant decline in satisfaction with the lenses over time. This is a prospective study to evaluate the efficacy of Tangible Boost, a monthly conditioning solution, to replenish the Hydra-PEG coating on rigid gas permeable contact lenses for patients with SJS, GVHD, and SS. Outcomes from this patient population will be compared to patients with dry eye disease.

Characterization of Diseases With Salivary Gland Involvement

Background: \- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics. Objectives: \- To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives. Eligibility: * People more than 4 years old who have or are suspected to have a disease involving salivary glands. * Their relatives more than 4 years old. * Healthy volunteers 18 years or older. Design: * Participants may be screened with: * Medical history * Physical exam * Blood and urine tests * General oral and dental history and exam * Saliva collection * Eye exam and test for dry eyes * Health questionnaires (adults) * Biopsy of some minor salivary glands. A small incision will be made on the inside of the lower lip and several tiny salivary glands will be removed. * Participants will have 2-3 visits. These may include: * Repeats of some screening tests * Ultrasounds of some glands. Researchers will put some gel on the face, then press on it with a smooth wand. * Adults may have other biopsies * A small catheter inserted into the opening of the parotid gland duct on the inside of the cheek. A saline solution (in a syringe) will fill the duct. * Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup * Scrapings collected from teeth, tongue, and cheeks

Generative AI Impact on Rheumatoid Arthritis Complications Diagnosis

Generative AI (GenAI) based on large language models (LLMs) is expected to improve the diagnosis and treatment of autoimmune diseases. We are studying how GenAI may affect the diagnosis of various complications of rheumatoid arthritis (RA). In a retrospective study using RA patients' EHR records, we will quantify physician adoption of GenAI predictions for RA complications and co-existing diseases. In a prospective observational study, we will assess the feasibility of using GenAI predictions as additional clinical information to help physicians make more complete diagnoses of RA complications and co-existing diseases, including complex, uncommon, or rare conditions.

An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease

An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease

A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.

Exploratory Study of the Efficacy of HuMoSCs (Human Monocyte-derived Suppressor Cells) on Glandular Involvement in Sjögren's Syndrome

Sjögren's syndrome is an autoimmune disease. Dry syndrome is a key feature of this condition, almost always leading to dryness of the mouth and eyes. It manifests as a decrease in the production of saliva and tears, causing discomfort for patients. This chronic dryness contributes to oral and ocular conditions. It is caused by lymphocytic infiltration of the exocrine glands, leading to their inflammation and subsequent fibrosis, which results in a decrease in fluid production by these glands. This chronic inflammation causes fatigue in the patient. Furthermore, in 30 to 60% of cases, Sjögren's syndrome may involve extra-glandular involvement, most commonly affecting the joints, but also involving the lungs, nervous system, and kidneys. Additionally, patients with thisdisease have a higher risk of developing lymphoma compared to unaffected individuals. The current treatment for Sjögren's syndrome is the same as that for dry eye syndrome; it is primarily symptomatic, involving lifestyle and dietary changes, the use of eye drops or oral lubricants, and medication to stimulate saliva production. To date, there is no medication available to treat Sjögren's syndrome and thus the cause of dry eye syndrome. In our laboratory (INSERM 1098, UMR Right), we have developed cells that suppress the immune system (immunosuppressive cells) derived from human monocytes cultured ex vivo using a patented process called HuMoSC (Human Monocyte -derived Suppressor Cells). These cells possess strong immunosuppressive capacity, already demonstrated in vitro and in vivo in mouse models. The aim of this study is to evaluate whether HuMoSCs can reduce the accumulation of immune cells and thereby decrease chronic inflammation and, in the longer term, limit the development of fibrosis (hardening with tissue destruction and scarring) in the salivary glands. Biopsy of the accessory salivary glands is already part of the diagnostic process for Sjögren's syndrome. During this biopsy, additional accessory salivary glands will be collected and sent to the laboratory for this study. These glands will be cultured in the presence of HuMoSC supernatant, and the impact of this treatment will be analyzed.

Fatigue in Primary Sjögren's Syndrome

Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

R-2487 in Patients With Sjogren's Syndrome (SS)

The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome. Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.

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 of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism

Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40. Inflammatory rheumatism, such as spondyloarthritis or rheumatoid arthritis, is less prevalent in women, but also affects young people, and is particularly common. Several disease-modifying treatments exist, depending on the severity and evolutivitý of the disease. Some are contraindicated or not recommended during pregnancy and therefore require supervision of pregnancy plans. In addition, some treatments have an immunosuppressive activitý, which implies an annual screening of cervical lesions by cervico-uterine smear. In this context, an adapted gynecological follow-up seems indispensable. The rheumatologist and the internist physician have a crucial role in advising and referring patients to their gynecological colleagues. Studying the qualitý of this gynecological follow-up in a cohort of patients with autoimmune disease or inflammatory rheumatism is of major interest.

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders

The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression. Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.

Sjogren's Mini-Pill Oral and Gut Microbiome Study

The goal of this observational study is to characterize and compare region-specific gastrointestinal, stool, oral, and periodontal microbiomes in adults with Sjögren's disease and healthy controls using ingestible mini-pill sampling technology. The study will include adults with Sjögren's disease and healthy control participants enrolled in a parent gastrointestinal microbiome study

B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome

The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)

Comprehensive Evaluation of Clinical and Biopsychosocial Characteristics in Primary Sjögren's Disease

Following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management, the evaluations will be performed once by the researchers and will take approximately one hour. In addition, healthy individuals with a similar average age to the evaluation group without any disease diagnosis will be included in the study as a control group. Evaluations of the healthy group will be made once by the researchers and will take approximately one hour. Data will be collected face to face at the Faculty of Physical Therapy and Rehabilitation, Rheumatology Unit. Data collection tool of the research: * Information about patients will be recorded with the Demographic Information Form. * EULAR Sjögren's Syndrome Disease Activity Index * EULAR Sjögren's Syndrome Patient Reporting Index * Primary Sjögren's Syndrome Quality of Life Scale * BETY-Biopsychosocial Questionnaire * Central Sensitization Scale * Pain Catastrophizing Scale * Hospital Anxiety and Depression Scale * Multidimensional Fatigue Rating Scale * Turkish Eating Assessment Tool * Yale Swallow Protocol * Test of Mastication and Swallowing Solids * Dysphagia Limit Test * Xerostomia inventory

Involvement of Immune Cells Derived From the Intestine in Sjogren's Syndrome

The study aims at defining the role of immune cells derived from the intestine in the pathogenesis of Sjogren's disease. This research might open new therapeutic approaches for the treatment of autoimmune diseases.

A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

Wheat-free Diet in the Treatment of Sjogren's Syndrome

Recent data show that some foods can increase intestinal mucosa permeability and immune activation of subjects with gastrointestinal (GI) symptoms. Wheat seems the most frequent food which activates this inflammatory response and can cause both GI and extra-intestinal symptoms. Patients suffering from wheat-related troubles, in absence of celiac disease diagnosis, can suffer from non-celiac wheat sensitivity (NCWS) and our previous studies showed that about 25% of them are also affected by autoimmune diseases (AD). A gluten-free diet (GFD) can influence inflammatory pattern of AD, including Sjogren's syndrome (SS). Thus, the investigators would enquire if SS patients may also suffer from NCWS and how a wheat-free diet (WFD) modifies their clinical features, and inflammatory and cytokine pattern. The investigators will also assess how wheat reintroduction, by an open challenge, modifies their clinical parameters, intestinal permeability, and both local and systemic inflammatory response.