Not yet recruitingRare disease

A study to evaluate the effect of obinutuzumab on removing specific immune cells in the tissues of patients with Sjögren's syndrome.

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Sjögren's syndrome, an autoimmune condition where the body's immune system attacks its own healthy cells, often causing dryness in the eyes and mouth. The research aims to determine if the drug obinutuzumab can reduce the number of harmful immune cells in the tissues affected by the disease. These specific cells, known as B cells, are responsible for producing proteins that mistakenly attack the body.

Participants in the study will receive the medication through an intravenous infusion, which means the medicine is delivered directly into the bloodstream through a needle in a vein. During the course of the study, medical professionals will monitor the effects of the treatment on the body over several months. This process includes observing changes in the salivary glands, which are the organs that produce saliva, and the lymph nodes, which are small structures that part of the immune system.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment initiation
The first step involves receiving an intravenous infusion, which is a method of delivering medication directly into a vein, of obinutuzumab. the dosage is 1,000 mg of the liquid solution.
Step 2
Monitoring and assessments
At 3 months after starting the medication, samples are collected from the blood, the salivary glands (the glands that produce saliva), and the lymph nodes (small structures in the immune system) to check for the reduction of specific b cells. these are cells that produce antibodies related to sjögren's syndrome.
Step 3
Follow-up evaluations
Assessments of disease activity are conducted at week 12, week 24, and week 36. these evaluations include measuring disease activity scores, patient and physician global assessments (which are scales used to rate how much the disease is affecting health), and symptom scales.
Additional tests are performed during these timeframes to measure tear production and saliva secretion.

Who can join the trial?

10 criteria

You must be an adult, meaning you are 18 years of age or older.
You must have primary Sjögren's syndrome, which is a condition where the body's immune system attacks its own healthy cells, specifically those that produce moisture.
Your diagnosis must meet specific medical standards called the EULAR/ACR 2016 classification criteria, which are sets of rules doctors use to confirm the disease.
Your blood tests must show the presence of certain markers, including ANA (anti-nuclear antibodies, which are proteins that mistakenly attack the center of your cells), anti-Ro60, and anti-La.
You must have cryoglobulinemia (a condition where certain proteins in the blood become thick or gel-like in cold temperatures) or show signs that could lead to lymphoproliferative disease (a group of conditions where white blood cells grow too much).
Signs that could indicate future disease include having rheumatoid factor antibodies (proteins that often cause inflammation), a history of lymphadenopathy (swollen lymph nodes), a history of salivary gland swelling, or a history of purpuric lesions (purple spots on the skin caused by bleeding) or vasculitis (inflammation of the blood vessels).
A lymphocytic focus score of 3 or more in a salivary gland biopsy (a small sample of tissue taken from the gland) is also a requirement.
Women of childbearing age must use a reliable method of contraception (birth control) during the study and for at least 18 months after the final injection.
You must provide signed written informed consent, which means you have read and agreed to all the study details in writing.
You must be willing to participate in all study activities, including tissue biopsies, which involve taking a small sample of tissue from the body for testing.

Who cannot join the trial?

20 criteria

You have an active inflammatory condition (a state where the body's immune system causes swelling and irritation) or an infectious condition (an illness caused by germs like bacteria or viruses).
The medication Obinutuzumab is listed as contra-indicated (meaning it is not safe for you to use) based on medical guidelines.
You need to receive live or attenuated viral vaccines (vaccines that use a weakened form of a germ) during the study or until your B-cells (a specific type of white blood cell that helps fight infection) return to normal levels.
You are currently participating in any other interventional clinical trials (medical studies where you receive a specific treatment).
You have previously used Obinutuzumab in a clinical trial or as a regular treatment.
You are currently using biologic DMARDs, targeted synthetic DMARDs, or classical DMARDs (these are different types of medicines used to suppress an overactive immune system).
You have received treatment with rituximab or other anti-CD20 therapies (medicines that target a specific protein on B-cells) less than 9 months before starting the study.
If you received rituximab or other anti-CD20 therapies between 9 and 12 months ago, your CD19+ B-cell count (a specific measurement of certain immune cells in your blood) must be lower than 80 cells per microliter.
You are currently taking more than 10 mg of prednisone (a type of steroid medicine) by mouth.
Your dose of prednisone has changed within the 4 weeks before your first visit.
You have received prednisone through an injection into a muscle, a joint, or a vein within the 4 weeks before your first visit.
You have tested positive for hepatitis B, hepatitis C, or Human Immunodeficiency Virus (HIV).
You are unable to follow the study rules or procedures, or you are staying in an institution due to a legal or regulatory order.
You have a positive pregnancy test or are currently breastfeeding.
You had an opportunistic infection (an infection that occurs more often in people with weakened immune systems) in the last 3 months.
You show signs of active tuberculosis (TB) through medical exams or lab tests.
You have a history of active tuberculosis that was treated within the last 3 years.
You have latent TB (a condition where the tuberculosis bacteria are in your body but are inactive and not causing illness).
You consume a large amount of alcohol, defined as more than 3 drinks per day.
You have liver cirrhosis (permanent scarring of the liver) or severe renal insufficiency (a serious decrease in how well your kidneys work).

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Stichting Radboud University Medical Center
Verified
Nijmegen, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Obinutuzumab is a medication given through a vein that works by targeting and removing specific types of immune cells called B cells. In this study, it is being used to see if it can reduce the harmful B cells that produce antibodies in people with Sjögren's syndrome.

Obinutuzumab

What is already known about the treatment

Obinutuzumab - This medication is administered through an intravenous infusion, which means it is delivered directly into a vein. It is a type of targeted therapy currently being studied for its ability to treat certain immune system disorders by reducing specific immune cells. The drug works by attaching to a specific protein on the surface of B cells, which are immune cells that can cause inflammation, and then triggering the body to destroy them. It is classified as a monoclonal antibody designed to deplete these problematic cells.

Investigated diseases

Sjögren's syndrome - This is a condition where the body's immune system mistakenly attacks its own healthy cells, particularly those in the glands that produce moisture. It primarily affects the salivary and tear glands, leading to reduced fluid production. Over time, the inflammation can cause dryness in the eyes, mouth, and other mucosal surfaces. The disease may also affect other parts of the body, including the joints, skin, and internal organs. The progression often involves a continuous immune response that can impact various bodily systems.