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Study of intravenous immunoglobulin combined with prednisone compared to prednisone alone in newly diagnosed patients with inflammatory myositis

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What is this trial about?

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

This clinical trial focuses on Idiopathic Inflammatory Myopathy, also known as myositis, which is a rare condition causing muscle inflammation and weakness. The study examines the effectiveness of combining two treatments: intravenous immunoglobulin (a protein solution derived from blood that helps fight diseases) and prednisone (a steroid medication), compared to using prednisone with placebo.

The purpose of this research is to determine if adding early intravenous immunoglobulin treatment to standard prednisone therapy helps patients with newly diagnosed myositis achieve better results after 12 weeks. The medication being tested is Nanogam, which is given through an intravenous (into the vein) infusion, along with sodium chloride solution.

During the study, participants receive either the combination of immunoglobulin and prednisone or prednisone with placebo. The treatment period lasts for three months, during which patients receive multiple infusions. The study is "double blind," which means neither the patients nor their doctors know which treatment combination each participant receives until the study is complete.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive treatment with prednisone and either immunoglobulin or placebo through an intravenous line (into your vein)

    The treatment will be administered in a double-blind manner, which means neither you nor your doctor will know which medication combination you are receiving

  2. Step 2

    Treatment duration

    Your treatment and monitoring period will last for 12 weeks

    During this time, you will receive regular infusions of the study medications

  3. Step 3

    Monitoring and assessments

    Your muscle strength will be tested using a method called Manual Muscle Testing (MMT)

    You will complete quality of life questionnaires using a form called EQ-5D

    Your physical activity will be measured using a special device

    You will undergo a whole body muscle MRI to examine muscle inflammation

    Blood samples will be taken to measure various markers including IgG levels

  4. Step 4

    Final evaluation

    After 12 weeks, your response to treatment will be evaluated using a total improvement score

    This score will help determine how well the treatment has worked for your condition

Who can join the trial?

9 criteria

  • Must be 18 years or older
  • Must have a diagnosis of one of these inflammatory muscle conditions:
    • Dermatomyositis (a condition causing muscle weakness and skin rash)
    • Antisynthetase syndrome (a condition affecting muscles and lungs)
    • Immune mediated necrotizing myopathy (a type of muscle damage caused by immune system)
    • Overlap/non-specific myositis, including polymyositis (inflammation of multiple muscles)
    • Must have been diagnosed less than 12 months ago
    • Must have at least 10% muscle weakness when tested, plus abnormal results in two other muscle function tests
    • Must be able to understand and sign the informed consent form
    • Can be either male or female

Who cannot join the trial?

15 criteria

  • Age below 18 or above 75 years
  • Currently pregnant or breastfeeding women
  • Previous treatment with immunoglobulins (IVIg) in the past 6 months
  • Known allergy or severe reaction to immunoglobulin products
  • Active cancer or history of cancer in the past 5 years
  • Severe kidney disease (as immunoglobulins can affect kidney function)
  • Active infection requiring antibiotic treatment
  • History of blood clots or thromboembolism (blood clots that travel through blood vessels)
  • Severe heart disease or recent heart attack
  • Other autoimmune diseases that require different treatment
  • Use of experimental drugs in another clinical trial within the past 30 days
  • Inability to provide informed consent
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could interfere with study participation
  • Lack of reliable contraception for participants of childbearing potential
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Verified sites

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  • Amsterdam UMC

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    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

  • Intravenous immunoglobulin (IVIg)

    is a medication made from donated blood plasma that contains antibodies. It helps to boost the immune system and reduce inflammation in muscle tissue. This medication is given through a vein (intravenously) and is commonly used to treat various autoimmune conditions.

  • Prednisone

    is a corticosteroid medication that helps reduce inflammation and suppress the immune system. It's commonly used to treat various inflammatory conditions, including muscle inflammation. This medication works by decreasing the body's immune response, which helps reduce swelling, redness, and pain.

What is already known about the treatment

  • Intravenous Immunoglobulin (IVIg)

    A blood product administered through intravenous infusion that contains pooled immunoglobulin G (IgG) antibodies from thousands of blood donors. This medication is widely used in medical practice for treating various autoimmune and inflammatory conditions, particularly in cases of idiopathic inflammatory myopathy (muscle inflammation). IVIg works by modulating the immune system response, reducing inflammation, and blocking harmful antibodies, making it an effective therapy when combined with other treatments. It belongs to the class of immunomodulating agents and has a well-documented safety profile in clinical practice.

  • Prednisone

    An oral corticosteroid medication that acts as a powerful anti-inflammatory and immunosuppressive agent, commonly used as a first-line treatment for inflammatory conditions including myositis. The medication works by reducing the activity of the immune system and decreasing inflammation throughout the body, which helps in managing symptoms of various autoimmune disorders. Prednisone belongs to the glucocorticoid class of medications and is typically taken in tablet form, with dosing adjusted based on the condition being treated and patient response.

Investigated diseases

Idiopathic Inflammatory Myopathy - A rare autoimmune disorder that causes muscle inflammation and weakness. The condition primarily affects skeletal muscles, which are responsible for body movement. Muscle weakness typically develops gradually over weeks or months, mainly affecting the muscles closest to the trunk of the body, particularly those in the shoulders, hips, and thighs. Patients may experience difficulty with everyday tasks such as climbing stairs, getting up from chairs, or lifting objects. The condition can also be accompanied by skin changes, fatigue, and joint pain. Some people may develop swallowing difficulties as the muscles involved in swallowing can become affected.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516057-42-00Estimated enrolment48 patientsSponsorAmsterdam UMC Stichting

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