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Sjogren's Syndrome clinical trials

View clinical trials related to Sjogren's Syndrome.

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NCT ID: NCT06454370 Recruiting - Sjogren's Syndrome Clinical Trials

Histopathological Analysis Versus Full-field Optical Coherence Tomography of Minor Salivary Gland Biopsy in Suspect Sjogren Syndrome

TOCOSS
Start date: June 7, 2024
Phase:
Study type: Observational [Patient Registry]

Primary Sjögren syndrome (pSS) is a systemic autoimmune disease that mainly affects the exocrine glands leading to severe dryness of mucosal surfaces, principally in the mouth and eyes. The other clinical manifestations are fatigue and musculoskeletal pain. Diagnosis of pSS associates clinical abnormalities with specific antibodies (Ro/SSA and La/SSB antibodies) or histopathological criteria of a minor salivary gland biopsy (the presence and number of lymphocytic focus, as well as chronicity findings like acinar atrophy, ductal dilatation or fibrosis). Apart from its variable sensitivity, one of the weaknesses of minor salivary gland biopsy is the delay in obtaining the result due to the time required to prepare the sample for histological analysis. Our group recently demonstrated the use of full-field optical coherence tomography (FF-OCT) to visualize structural changes associated with the inflammatory processes in Giant Cell Arteritis (temporal artery biopsy examination). It may suggests a further use of dynamic FF-OCT of minor salivary gland biopsy to visualize structural changes associated with the lymhocytic focus to ensure rapid on-site diagnosis of pSS.

NCT ID: NCT06440525 Not yet recruiting - Clinical trials for Primary Sjögren Syndrome

A Phase 2 Study of RSLV-132 in Females With Primary Sjögren's Syndrome

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to learn if RSLV-132 improves the symptoms of pSS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are: - Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain? - Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's? - What are the blood levels of RSLV-132 over time? - What is the immune (antibody) response in the body to RSLV-132? - What is the safety profile of RSLV-132? Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS. Participants will: Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device

NCT ID: NCT06437652 Recruiting - Sjogren's Syndrome Clinical Trials

An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome

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

The aim of this research is to discover an artificial intelligence (AI) algorithm for lymphocyte focus score in whole slide images of labial minor salivary gland (SG) biopsy samples for diagnosing Sjogren's Syndrome, in order to enhance the precision of pathological interpretation of labial minor SG biopsy samples in patients with suspected Sjogren's syndrome and aid clinicians make an accurate diagnose. A remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG will be built for the global based on the research results. The research will propose the AI-assisted pathological interpretation of lymphocyte focus score in labial minor SG biopsy samples in the future guidelines for the diagnosis and treatment of Sjogren's syndrome. The research will: 1. Develop and debug the AI algorithm for lymphocyte focus score in whole slide images of labial minor SG biopsy samples for diagnosing Sjogren's Syndrome; 2. Internal test of the AI algorithm; 3. Clinical validation of the AI algorithm with blind method in multiple centers; 4)Built a remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG for the global and Explore its clinical application.

NCT ID: NCT06432101 Completed - Clinical trials for Primary Sjögren's Syndrome

Acupuncture Combined With Hydroxychloroquine

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

To observe the clinical efficacy of acupuncture combined with hydroxychloroquine sulfate tablets on the symptoms of dry mouth and dry eyes in primary Sjögren's syndrome.

NCT ID: NCT06428188 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases

BAH247
Start date: May 29, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed/ Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.

NCT ID: NCT06420154 Not yet recruiting - Systemic Sclerosis Clinical Trials

The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases

Start date: May 27, 2024
Phase: Early Phase 1
Study type: Interventional

This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.

NCT ID: NCT06417398 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

Start date: May 14, 2024
Phase: Early Phase 1
Study type: Interventional

To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID. To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID. To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects. To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects.

NCT ID: NCT06411639 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Pharmacokinetics Study of Ianalumab in Chinese Participants With Autoimmune Diseases

Start date: November 25, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this pharmacokinetic (PK) study is to describe the PK profile of ianalumab following s.c. administration in Chinese participants with systemic lupus erythematosus (SLE) and/or Sjögren's disease (SjD). Collection of intensive PK data from Chinese population had been designed in the ianalumab Phase 3 studies of SjD CVAY736A2302 (NCT05349214) and lupus nephritis (LN) CVAY736K12301 (NCT05126277) on an optional basis. This study is conducted to provide supplementary Chinese PK data in addition to the intensive PK data from the two Phase 3 studies .

NCT ID: NCT06411132 Recruiting - Dry Eye Clinical Trials

Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye

GEMINAE
Start date: March 15, 2024
Phase:
Study type: Observational

Primary Objective - To assess the proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity. Secondary Objectives - To assess corneal sensitivity via Cochet-Bonnet esthesiometer. - To assess tear secretion via Schirmer I test. - To assess OPAS questionnaire results.

NCT ID: NCT06410833 Recruiting - Pediatric ALL Clinical Trials

Belimumab After Rituximab in Resistant Primary Juvenile SS

BRRPJS
Start date: March 9, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to explore the effectiveness of sequential use of rituximab and belimumab in the treatment of resistant primary juvenile Sjogren's syndrome. Does sequential use of rituximab and belimumab reduce the activity of SS in resistant patients Researchers will compare the disease activity before and after the treatment of sequential use of rituximab and belimumab to see if the therapy works to treat SS. Participants will: Recieve Rituximab each week for 2-4 times until B%<0.5% or B#<20×10^6/L Recieve Belimumab 4 weeks after the last use of Rituximab, and then every 4 weeks until week 28