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Sjogren's Syndrome clinical trials

View clinical trials related to Sjogren's Syndrome.

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NCT ID: NCT05644795 Recruiting - Sjogren's Syndrome Clinical Trials

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

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

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.

NCT ID: NCT05605665 Recruiting - Sjögren's Syndrome Clinical Trials

Low-dose Interleukin-2 and Rapamycin on sjögren's Syndrome

Start date: November 5, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this paper is to analysis of therapeutic effect and immunological mechanism of low-dose IL-2 combined with rapamycin in the treatment of Sjogren's syndrome

NCT ID: NCT05605314 Recruiting - Dry Eye Clinical Trials

Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye

pSS
Start date: January 1, 2021
Phase:
Study type: Observational

Primary Sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body.

NCT ID: NCT05528809 Recruiting - Clinical trials for Systemic Sclerosis, Diffuse

Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis

CIRCEE
Start date: October 12, 2022
Phase: N/A
Study type: Interventional

Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial aggression, and thus possibly constitute a biomarker.

NCT ID: NCT05443685 Recruiting - Clinical trials for Sjogren-Larsson Syndrome

ADX-629 Therapy for Sjogren-Larsson Syndrome

Start date: January 2, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This research study will determine whether orally administered ADX-629 is safe and has biochemical efficacy in patients with Sjögren-Larsson syndrome (SLS), a rare inherited disorder of fatty aldehyde metabolism The disease is caused by bi-allelic mutations in ALDH3A2, which results in deficient activity of fatty aldehyde dehydrogenase (FALDH) and leads to the build-up of harmful long-chain (C16-C20) aldehydes and alcohols. Accumulation of these lipids and their metabolic products in skin, brain and eyes is responsible for the symptoms, which persist lifelong. ADX-629 is an aldehyde trapping agent that is expected to eliminate fatty aldehydes and negate aldehyde toxicity, improve the biochemical abnormalities and have clinical efficacy for SLS. The primary objective of this clinical protocol is to determine whether ADX-629 is safe and tolerable for use in SLS subjects. The secondary objective is to determine the efficacy of ADX-629 in reversing the biochemical abnormalities in SLS. Exploratory objectives are to evaluate the short-term clinical effects of ADX-629 on neurologic, cutaneous and ophthalmologic disease in SLS. Patients will be treated with ADX-629 for 12 weeks and monitored for safety and biochemical efficacy.

NCT ID: NCT05383677 Recruiting - Sjogren's Syndrome Clinical Trials

Anifrolumab Treatment for 24 Weeks in Patients With Primary Sjögren's Syndrome

ANISE-II
Start date: October 1, 2022
Phase: Phase 2
Study type: Interventional

The ANISE-II study is a randomized, double-blind, placebo-controlled phase IIa proof-of-concept trial. Thirty patients with primary Sjögren's syndrome (pSS) are randomized in a 2:1 ratio to either anifrolumab or placebo treatment for 24 weeks. Main inclusion criteria are fulfilment of the ACR/EULAR classification criteria for pSS, disease duration of ≤10 years, and an ESSDAI and/or ESSPRI of ≥5 (at least 50% of patients need to fulfil the ESSDAI ≥5 criterion). The primary outcome measure is Composite of Relevant Endpoints for Sjögren's Syndrome (CRESS) response at week 24.

NCT ID: NCT05349214 Recruiting - Sjogren Syndrome Clinical Trials

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-2
Start date: August 4, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

NCT ID: NCT05312944 Recruiting - Sjogren's Syndrome Clinical Trials

Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome

PASS
Start date: March 2, 2021
Phase:
Study type: Observational

To determine the phenotype of patients having PMR symptoms and primary Sjogren syndrome (pSS), we used a French national call to identify patients combining both diseases and collected retrospective clinical and biological data.

NCT ID: NCT05115487 Recruiting - Sjogren's Syndrome Clinical Trials

Evaluation of Hand Functions in Newly Diagnosed Primary Sjögren's Syndrome

Start date: October 15, 2021
Phase:
Study type: Observational

Hand functions are decreased in rheumatic diseases such as systemic sclerosis and rheumatoid arthritis. Sjögren's syndrome (SS) is a chronic systemic rheumatic disease characterized by lymphoplasmacytic infiltration of exocrine glands, especially salivary and lacrimal glands. SS may be "primary" when it occurs alone (pSS) and "secondary" (sSS) when associated with another autoimmune disease. PSS is the most common connective tissue disease after rheumatoid arthritis and affects 0.3-3% of the population. Joint involvement is the most common involvement of pSS after sicca syndrome (50% of patients). Patients may have arthralgia with inflammatory features (morning stiffness > 30 minutes) or, less frequently, true symmetric polysynovitis mimicking rheumatoid arthritis (RA). The joint involvement of PSS is usually moderate (<5 affected joints) and mostly affects the small joints of the hands and upper extremities. PSS may also be responsible for myositis. Widespread pain, similar to primary fibromyalgia, is common in about 50 percent of patients with PSS. The hand is one of the most important components affecting the functionality of the upper extremity. Grasping is one of the hand functions, for the continuity of daily living activities. is an important function. Studies have shown that hand grip strength is correlated with upper extremity muscle strength, as well as general body muscle strength and pulmonary muscle strength. As far as we know, hand functions have not been evaluated in newly diagnosed patients with pSS.

NCT ID: NCT05113004 Recruiting - Clinical trials for Primary Sjögren's Syndrome (pSS)

New Clinical End-points in Patients With Primary Sjögren's Syndrome

NECESSITY
Start date: January 20, 2022
Phase: Phase 2
Study type: Interventional

There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS. Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.