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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Aojfldjmc Udq Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
13.09.2021

Trial locations

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.

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 ID:
2024-516057-42-00
Trial Phase:
Therapeutic exploratory (Phase II)

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