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Study on the Effectiveness of Human Normal Immunoglobulin for Treating Painful Nerve Damage in Patients with Primary Sjögren's Syndrome

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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment for Primary Sjögren's Syndrome, a condition that can cause painful nerve problems known as peripheral neuropathies. The treatment being tested is called Privigen, which is a solution containing human normal immunoglobulin. This is a type of protein that is usually found in the blood and helps the immune system fight infections. The study will compare the effects of Privigen with a placebo to see if it can help reduce the pain and improve the quality of life for people with this condition.

Participants in the study will receive either the Privigen treatment or a placebo over a period of time. The study aims to see if there is an improvement in symptoms such as pain and overall nerve function. The treatment is given as an infusion, which means it is administered directly into the bloodstream through a vein. The study will also monitor any side effects that participants might experience during the treatment period.

The purpose of this study is to determine if Privigen can effectively treat the nerve-related symptoms associated with Primary Sjögren's Syndrome. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for individuals suffering from this condition. The study will last for several weeks, and participants will be closely monitored to assess the treatment's impact on their symptoms and overall health.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including being between 18 and 80 years old, having primary Sjögren's syndrome, and experiencing peripheral neuropathy.

    The patient must have adequate renal function and undergo viral evaluations. Effective contraception is required during the study period.

    The patient must be capable of understanding the study information and provide written consent.

  2. Step 2

    Initial treatment phase

    The patient will receive a treatment called Privigen, which is a solution for infusion containing human normal immunoglobulin.

    The infusion is administered intravenously, meaning it is given directly into a vein.

    The treatment aims to demonstrate the effectiveness of intravenous immunoglobulins in treating peripheral neuropathies associated with primary Sjögren's syndrome.

  3. Step 3

    Treatment duration and frequency

    The treatment is administered over a period of several weeks, with specific intervals between each infusion session.

    The exact dosage and frequency of the infusions will be determined by the study protocol and the patient's response to the treatment.

  4. Step 4

    Evaluation of treatment effectiveness

    The primary goal is to achieve an improvement of at least 20% over placebo in specific scales, such as the R-ODS scale and the Numerical Pain Scale, three weeks after the last treatment course.

    Secondary evaluations include quality of life assessments, depression scores, fatigue scales, and other criteria related to Sjögren's syndrome and neuropathy.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, the patient will be monitored for any adverse reactions to the treatment.

    Regular follow-up appointments will be scheduled to assess the patient's progress and any changes in symptoms.

  6. Step 6

    Completion of the study

    The study is expected to conclude by December 18, 2025.

    Upon completion, the patient's overall response to the treatment will be evaluated, and the results will contribute to understanding the treatment's effectiveness for primary Sjögren's syndrome-related neuropathies.

Who can join the trial?

10 criteria

  • Must be between 18 and 79 years old.
  • Must have Primary Sjögren's syndrome, which is a condition defined by specific European and American criteria.
  • Must have Peripheral neuropathy, which is a problem with the nerves that can cause numbness or weakness. This can be either purely sensory (affecting feeling) or sensorimotor (affecting both feeling and movement). It must be confirmed by a test called EMG (Electromyography), which checks the health of muscles and the nerves that control them.
  • Must have good renal function (kidney health), with a clearance rate greater than 50 ml/min/1.73m². If there is an abnormal result, a second test can be done within two weeks.
  • Must have a viral evaluation for HIV and hepatitis.
  • Must use effective contraception during the study period to prevent pregnancy.
  • Must be able to understand information about the study and give consent to participate.
  • Must be informed of the results of a preliminary medical exam.
  • Must have healthcare insurance.
  • Must sign a written consent form to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients with **peripheral neuropathy** that is clearly defined. This includes:
    • **Pure sensitive neuropathy**: A condition affecting the nerves that mainly impacts sensation.
    • **Sensorimotor neuropathies**: A condition affecting the nerves that impacts both sensation and movement.
    • **Proved EMG**: A test called electromyography that confirms nerve problems.
    • Patients with **primary Sjögren's syndrome** as defined by European and American criteria. This is an autoimmune disease where the body's immune system attacks its own moisture-producing glands.
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Investigated drugs

Polyvalent Intravenous Immunoglobulins (IV Ig) are used in this study to treat painful sensory neuropathies associated with primary Sjögren's syndrome. These immunoglobulins are a mixture of antibodies that are administered through a vein. They are intended to help modulate the immune system and reduce inflammation, potentially alleviating nerve pain and improving nerve function in patients with this condition.

What is already known about the treatment

Intravenous Immunoglobulin (IV Ig) – This medication is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. Currently, IV Ig is being studied in clinical trials for its effectiveness in treating painful sensory neuropathies associated with primary Sjögren's syndrome. It is primarily used for its immune-modulating properties, helping to regulate the immune system's activity. At the molecular level, IV Ig works by providing a broad spectrum of antibodies that can neutralize harmful autoantibodies and modulate immune responses. It is classified pharmacologically as an immunoglobulin therapy.

Investigated diseases

  • Peripheral Neuropathy

    Peripheral neuropathy is a condition that affects the peripheral nerves, which are responsible for transmitting signals between the central nervous system and the rest of the body. It can manifest as pure sensory neuropathy, affecting only sensation, or as sensorimotor neuropathy, impacting both sensation and movement. Symptoms often include tingling, numbness, and pain, primarily in the hands and feet. The progression of the disease can lead to muscle weakness and loss of coordination. The condition may be caused by various factors, including diabetes, infections, and autoimmune diseases. Diagnosis is typically confirmed through electromyography (EMG) tests.

  • Primary Sjögren's Syndrome

    Primary Sjögren's syndrome is an autoimmune disorder characterized by the body's immune system mistakenly attacking its own moisture-producing glands. This leads to symptoms such as dry mouth and dry eyes, which are the most common manifestations. Over time, the condition can also affect other parts of the body, including the joints, kidneys, and nerves. The disease is often associated with fatigue and joint pain, and it can significantly impact the quality of life. It is diagnosed based on specific criteria established by European and American guidelines. The condition is chronic and can vary in severity among individuals.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517309-95-00Protocol code6621Estimated enrolment24 patientsSponsorLes Hopitaux Universitaires De Strasbourg

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