Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy

This research study is for people recently diagnosed with a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP affects your nerves and can cause weakness and numbness. The study aims to compare two different ways of giving a common treatment called immunoglobulin. One method is a medicine called Hizentra, given as an injection just under the skin. The other is Privigen, given through a drip into a vein. Researchers want to see which method works better at improving your ability to do daily activities, your muscle strength, and your overall quality of life. The study will follow participants for up to 60 weeks to understand these effects.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Region Midtjylland

Enrolment target

Start

15 Oct 2024

Chronic inflammatory demyelinating polyneuropathy (CIDP)

What is this study about?

This study is designed to help us understand the best way to treat a nerve condition called Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP for short. If you have CIDP, your body's immune system mistakenly attacks its own healthy nerve coverings, which can lead to muscle weakness, numbness, and difficulty with movement.

Immunoglobulin is a common treatment for CIDP, which helps calm down the immune system. We already know it works, but this study is comparing two different ways to give it. One way is an injection given just under the skin, similar to a diabetes injection. The other is given through a drip that goes into one of your veins, usually in your arm. The main goal is to see if one method helps you more with your daily activities and makes you feel better. They'll be looking at things like how easily you can walk or use your hands.

They will also be checking other important things, like how strong your muscles are, how well you can feel things, your overall quality of life, any pain you might have, and how generally tired you feel. This information will help doctors recommend the best treatment option for people with CIDP in the future, giving them more choices about how they receive their medication.

Key takeaways

Compares two ways to give CIDP medicine: injection under skin vs. drip into vein.
Aims to improve understanding ofCIDP treatment options.
Measures changes in daily activities, muscle strength, and quality of life.
Suitable for adults (18+) newly diagnosed with CIDP.
Study involves regular visits and health checks over several months.

Who may be eligible?

To join this study, people must be at least 18 years old and have recently been diagnosed with CIDP. This means you haven't received treatment for CIDP before. Both men and women can take part.

The research is looking for people who are just starting their treatment journey for CIDP. The doctors involved will carefully check your medical history and current health to make sure the study is a good fit for you and that you'll be safe taking part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently been diagnosed with CIDP?
Have you not received any CIDP treatment before?
Are you able to attend regular appointments for treatment and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be regularly seen by the study team. You'll either receive medication as an injection under your skin or through a drip into a vein. These treatments will be given at set times. Throughout the study, you'll answer questionnaires about your daily activities, how you feel, and any pain, and you'll have tests for muscle strength and movement. This will help the team understand how well the treatment is working for you. You'll also have blood tests at different points. The first part of the study will last for 26 weeks, but you could be followed for up to 60 weeks in total to find the best effective dose. The specific number of visits and tests will be explained to you in detail.

Potential risks and benefits

Participating in research can sometimes help you get closely monitored care for your condition. However, it's also important to remember that there might be side effects from the medication, as with any treatment. The study team will explain all known potential risks to you. You are always in control and can stop participating at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is CIDP?

CIDP is a long-term nerve condition where your immune system affects the protective covering of your nerves, leading to weakness and numbness.

What kind of treatments are being compared?

The study is comparing two ways to give immunoglobulin: injections under the skin (Hizentra) or through a drip into a vein (Privigen).

How long will the study last?

The main part of the study is 26 weeks, but you might be followed for up to 60 weeks in total to find the best treatment dose for you.

Will I have to pay to be in the study?

No, all study-related treatments and tests are provided as part of your participation.

What if I get worse during the study?

Your health will be closely monitored, and you can discuss any concerns with the study team at any time. You can also leave the study at any point.