Clinical trials on Sjogren Syndrome

Overview of Sjogren Syndrome

Sjogren Syndrome is a chronic autoimmune disorder characterized by the body’s immune system mistakenly attacking its own moisture-producing glands. This primarily affects the salivary and lacrimal glands, leading to the hallmark symptoms of dry mouth (xerostomia) and dry eyes (keratoconjunctivitis sicca). However, it can also involve other organs and systems, presenting a wide range of symptoms beyond dryness. Sjogren Syndrome can occur independently (Primary Sjogren Syndrome) or in conjunction with other autoimmune diseases such as rheumatoid arthritis or lupus (Secondary Sjogren Syndrome). The exact cause of Sjogren Syndrome remains unknown, but a combination of genetic, environmental, and hormonal factors is believed to contribute to its development. Diagnosis is often challenging due to the overlap of symptoms with other conditions and the variability in how it presents among individuals. A comprehensive evaluation including blood tests, eye exams, and biopsy of salivary glands can help in confirming the diagnosis. While there is no cure for Sjogren Syndrome, treatment focuses on managing symptoms and preventing complications. This may involve the use of artificial tears, saliva substitutes, medications to stimulate saliva production, and immunosuppressive agents.
  • Key Symptoms: Dry eyes, dry mouth, fatigue, joint pain.
  • Diagnostic Tests: Blood tests, Schirmer’s test, salivary gland biopsy.
  • Treatment Approaches: Symptom management, lifestyle modifications, and in some cases, immunosuppressive therapy.

Prognosis for Sjögren’s Syndrome: Understanding Long-Term Outcomes

Sjögren’s Syndrome is an autoimmune disorder characterized by dry eyes and mouth due to the dysfunction of moisture-producing glands. The long-term prognosis for individuals with Sjögren’s Syndrome varies; many can lead full, productive lives with proper management of symptoms. However, the chronic nature of the condition necessitates ongoing attention to symptom control. There may be fluctuating levels of discomfort, and in some instances, complications such as dental issues or more serious systemic effects can arise. The risk of lymphoma, although low, is elevated compared to the general population. Regular monitoring and supportive care are crucial in managing the symptoms and improving quality of life. Life expectancy for those with Sjögren’s Syndrome is generally not significantly affected, but vigilance is essential in addressing the diverse challenges presented by the condition over time.

Complications in Sjögren Syndrome

Sjögren Syndrome can lead to various complications that may impact daily life. Dry eyes, a common issue, can cause irritation and increased risk of infections or corneal damage. Dry mouth might result in dental problems such as cavities, gum disease, or oral yeast infections, complicating eating and speaking. Swelling of the salivary glands can occur, which can be uncomfortable and affect facial appearance.

Additionally, dryness can extend to other areas such as the skin, nose, and throat, leading to discomfort and respiratory issues. Fatigue and joint pain are also frequent, potentially hindering routine activities and reducing overall energy levels. In more severe cases, Sjögren Syndrome can affect internal organs like the kidneys or lungs and may be associated with an increased risk of lymphoma. These complications can significantly affect health and quality of life, making daily tasks more difficult.

Treatment Methods for Sjögren Syndrome

For the management of Sjögren Syndrome, several non-clinical trial treatments are recommended. Dietary adjustments, such as the increase in water intake and the consumption of foods that promote hydration, can alleviate symptoms of dryness. The inclusion of Omega-3 supplements may also prove beneficial. Regular physical activity, particularly exercises that enhance moisture production like yoga or pilates, is encouraged.

  • Pharmacotherapy options include the use of over-the-counter saliva substitutes and artificial tears to relieve dryness.
  • Prescription medications such as pilocarpine or cevimeline can stimulate saliva and tear production.
  • The maintenance of good oral hygiene practices is crucial, and the use of fluoride toothpaste or mouthwash may be recommended to prevent dental issues.

Modern technology offers solutions like humidifiers to add moisture to the environment, reducing discomfort from dryness. Special glasses or goggles can assist in maintaining eye moisture. Smartphone apps are available to remind individuals to hydrate regularly and to track symptom patterns for better management.

  • CT-EU-00115122

    24-Week Anifrolumab treatment study for primary Sjögren’s syndrome

    The ANISE-II study is a research project designed to explore the effectiveness and safety of a medication called Anifrolumab in treating Primary Sjögren’s Syndrome (pSS), a condition that affects your immune system. This study is particularly important because it aims to find new ways to manage pSS, which can cause symptoms like dry mouth and eyes, fatigue, and joint pain.

    In this study, participants will be divided into two groups. One group will receive Anifrolumab, a medication given through an IV (intravenous infusion) once every four weeks for a total of 24 weeks. The other group will receive a placebo, which is a treatment that looks like the medication but does not contain any active substance. This is done to compare the effects of Anifrolumab with no treatment at all.

    The main goal of the ANISE-II study is to see if Anifrolumab can help improve symptoms and quality of life for people with pSS. This will be measured using something called the Composite of Relevant Endpoints for Sjögren’s Syndrome (CRESS) at week 24, which looks at various aspects of the disease, including systemic disease activity, patient-reported symptoms, and the health of tear and salivary glands.

    To be eligible for this study, patients must meet certain criteria, such as having been diagnosed with pSS according to specific guidelines, having had the disease for no more than 10 years. They must also experience a certain level of disease activity and symptoms.

    • placebo
    • Anifrolumab
  • Evaluating Ianalumab for active Sjogren’s syndrome

    The NEPTUNUS-2 study is a significant research project aimed at exploring the effectiveness and safety of a medication called ianalumab (VAY736) for individuals suffering from active Sjogren’s Syndrome. This study is designed as a three-arm, randomized, double-blind, placebo-controlled trial, which means participants will be randomly assigned to one of three groups: two will receive ianalumab at different intervals, and one will receive a placebo, with neither the participants nor the researchers knowing which group participants are in to ensure unbiased results.

    The main goal of this study is to determine how well ianalumab can improve the symptoms of Sjogren’s Syndrome compared to a placebo. This will be measured by the change in a specific score called the EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) from the start of the study to week 48. The ESSDAI score helps doctors understand how active the disease is, with a higher score indicating more active disease. A decrease in this score over time would suggest an improvement in the condition.

    Participants in this study will receive ianalumab injections either once a month or every three months, depending on the group they are assigned to. The study emphasizes not only the potential benefits of ianalumab in treating Sjogren’s Syndrome but also its safety and tolerability, ensuring that the treatment is not only effective but also safe for patients.

  • Long-term safety study of efgartigimod in the treatment of primary Sjögren’s syndrome

    The study focuses on examining the medication efgartigimod and its potential to assist adults with Primary Sjögren’s Syndrome (pSS). Participants who have taken part in previous efgartigimod studies may qualify for this extension study. The primary aim is to assess the long-term safety of efgartigimod for individuals with pSS.

    During the 48-week duration of the study, participants will receive efgartigimod treatment. It’s important to understand that individuals from both the active and placebo groups of previous studies can participate, but they will not be informed of their previous group assignment. The researchers will closely monitor any side effects, including serious ones, as well as any changes in participants’ laboratory test results or vital signs throughout the study.

    This study offers an opportunity to further investigate the potential benefits of efgartigimod in managing pSS, particularly in reducing IgG autoantibodies, which are thought to contribute to the disease. Participation in the study could provide valuable insights into the long-term safety of this treatment.

    • Efgartigimod
  • Deucravacitinib: A possible solution for active Sjögren’s Syndrome

    The study aims to evaluate the effectiveness and safety of the medication Deucravacitinib, also known as BMS-986165, in adults diagnosed with Active Sjögren’s Syndrome, a condition characterized by symptoms like dry eyes and mouth. The study is designed to understand how well Deucravacitinib can alleviate these symptoms compared to a placebo. This is done over a series of regular checks over time to monitor the improvement in symptoms and the overall safety of the medication for participants.

    Deucravacitinib will be given in two different doses to different groups of participants to determine which dose is more effective. Those on the placebo will later receive one of the doses of Deucravacitinib. The study will assess changes in various symptoms and measures of disease activity at several points during the study, providing insights into both the short-term and longer-term effects of the treatment.

    Throughout the study, participants will have their symptoms monitored and will undergo various assessments to see if there is any improvement in their condition and to check for any possible side effects from the medication. This includes checking the severity of their symptoms, overall health, and any changes in their body’s response to the treatment.

    • Deucravacitinib
  • Testing the effectiveness and safety of ianalumab for Sjogren’s Syndrome

    This is a study called NEPTUNUS-1. In it, the researchers are testing a drug called ianalumab. It’s designed to help people who suffer from Sjogren’s syndrome, which is a condition that causes dry eyes and mouth, among other things. The main aim is to find out how this drug affects people’s symptoms. It involves two groups of people. One will receive the drug, while the other will receive a placebo (a kind of pretend medicine that doesn’t do anything). Neither the people nor the doctors will know who’s getting what until the end. This is done to make sure the results are as fair as possible. The researchers will measure how people’s symptoms change over time.

    • Ianalumab/VAY736
  • Long-term safety & efficacy study for Ianalumab in Sjogrens syndrome

    This study is testing a drug called ianalumab to see if it can help people with Sjogren’s syndrome. Participants will receive the drug once a month or once every three months. The study will last approximately five years. It involves taking the drug for three years and then being followed by researchers for another two years. Doctors are interested in whether the drug will work for a long time and whether it will be safe. What is important is that the study participants will be patients who have already completed the previous trial. If a patient received placebo treatment in the previous study, they will now receive the real drug once a month or once every three months. The most significant thing is to understand how this drug helps Sjogren’s syndrome eventually.

    • VAY736 (Ianalumab)