Study Comparing Subcutaneous and Intravenous Human Normal Immunoglobulin for New Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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What is this study about?

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is comparing two treatments for CIDP: Hizentra and Privigen. Both treatments contain a substance called human normal immunoglobulin, which is derived from human blood and helps to boost the immune system. Hizentra is given as a subcutaneous injection, meaning it is injected under the skin, while Privigen is administered as an intravenous infusion, meaning it is delivered directly into a vein.

The purpose of the study is to evaluate the effects of these treatments in patients who have not previously received treatment for CIDP. Participants will be randomly assigned to receive either Hizentra or Privigen. The study will last for a total of 26 weeks, during which the effects of the treatments on the participants’ symptoms will be monitored. This includes changes in their overall disability, muscle strength, and sensory function. The study will also assess the participants’ quality of life, pain levels, and satisfaction with the treatment.

Throughout the study, participants will undergo various tests to measure their progress. These tests include assessments of grip strength, walking ability, and other functional abilities. Blood samples will also be taken to monitor levels of immunoglobulin and other blood components. The study aims to determine which treatment is more effective in managing the symptoms of CIDP and improving the overall well-being of the participants.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of the diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) and an evaluation of the Overall Disability Sum Score (ODSS) to ensure it is greater than 1.

2 randomization

Participants are randomly assigned to one of two groups: one receiving subcutaneous immunoglobulin (SCIG) and the other receiving intravenous immunoglobulin (IVIG). This process ensures that each participant has an equal chance of being placed in either group.

3 treatment phase I

The treatment period lasts for 26 weeks. Participants in the SCIG group receive Hizentra 200 mg/ml solution through subcutaneous injection. Participants in the IVIG group receive Privigen 100 mg/ml solution through intravenous infusion. The frequency and dosage are determined by the study protocol and medical team.

4 monitoring and assessments

Throughout the treatment phase, regular assessments are conducted to monitor changes in the Overall Disability Sum Score (ODSS), muscle strength, sensory parameters, and functional abilities. These assessments include tests such as the 10-meter-walk test, grip strength measurement, and quality of life questionnaires.

5 treatment phase II

After the initial 26 weeks, participants may continue to receive treatment until the lowest effective dosage of immunoglobulin is reached, up to a maximum of 60 weeks. Adjustments to the treatment plan are made based on individual responses and assessments.

6 final evaluation

At the end of the study period, a final evaluation is conducted to assess the overall effectiveness of the treatment. This includes a comprehensive review of all collected data and a final measurement of the Overall Disability Sum Score (ODSS).

Who Can Join the Study?

Patients must be diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which is a condition affecting the nerves.
The diagnosis should meet the criteria set by the European Federation of Neurological Societies and the Peripheral Nerve Society. These criteria help doctors confirm the presence of CIDP.
Patients should be between the ages of 18 and 79 years old.
Patients must have an Overall Disability Sum Score (ODSS) greater than 1. This score is used to measure the level of disability or difficulty in performing daily activities.
Both male and female patients can participate.

Who Cannot Join the Study?

Patients who have a different condition than Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.06.2019

Trial locations

Investigated drugs:

Human Normal Immunoglobulin

Subcutaneous Immunoglobulin (SCIG) is a treatment that involves injecting immunoglobulin, a type of protein that helps your immune system fight infections, under the skin. This method allows the medication to be absorbed slowly into the body. In this trial, SCIG is being tested to see how well it works for people who have not been treated before for a condition called chronic inflammatory demyelinating polyneuropathy (CIDP), which affects the nerves and can cause weakness and numbness.

Intravenous Immunoglobulin (IVIG) is another form of immunoglobulin therapy, but instead of being injected under the skin, it is given directly into a vein. This allows the medication to enter the bloodstream quickly. The trial is comparing IVIG to SCIG to determine which method is more effective for new patients with CIDP over a 26-week treatment period.

Investigated diseases:

Chronic inflammatory demyelinating polyradiculoneuropathy

Chronic inflammatory demyelinating polyneuropathy (CIDP) – This is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. The disease progresses slowly, often over several months, and can lead to significant disability if untreated. Symptoms may include tingling or numbness, muscle weakness, loss of deep tendon reflexes, and fatigue. The course of CIDP can vary, with some individuals experiencing periods of improvement and others having a steady progression of symptoms. The exact cause of CIDP is unknown, but it is believed to be an autoimmune disorder.

Trial ID:

2024-515898-96-01

NCT ID:

NCT04589299

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study Comparing Subcutaneous and Intravenous Human Normal Immunoglobulin for New Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?