Testing the efficacy of injecting immunoglobulins under the skin in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Start Date
01/04/2010
Expected end Date
01/12/2011
Location
Europe
Status
Ongoing but has finished recruiting patients

What is the aim of the trial?

This phase 2 study aims to test whether subcutaneous immunoglobulin treatment is effective for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

CIDP is an autoimmune disorder – a condition in which the body directs an immune response towards itself instead of foreign materials. In CIDP this response is directed towards the myelin, a fatty substance that covers nerve fibres and allows the communication between nerves and muscles. This causes muscle weakness, numbness, pain and difficulty in walking.

To date, there is no cure for CIDP, but there are effective immunosuppressive therapies available to alleviate the symptoms and improve quality of life. One of the treatments used for CIDP patients is injecting immunoglobulins directly into the blood stream (intravenous). Immunoglobulins are also called antibodies and when they are given to patients with autoimmune conditions they help to shut down the abnormal autoimmune response. However, the administration of intravenous immunoglobulin requires regular and frequent hospital admissions and is often accompanied by unpleasant side effects causing discomfort to the patients.

In this trial the immunoglobulin treatment will be administered under the skin (subcutaneously) without requiring hospital admission. This study aims to find out if injecting immunoglobulins under the skin is as effective as injecting it into the blood stream.

Who can be involved in the trial?

The study aims to recruit around 30 people diagnosed with CIDP, both male and female, aged 18 to 80, who are receiving regular treatment with intravenous immunoglobulins in one of the neurological departments in Denmark.

Participation is not possible in the case of: pregnancy, breast feeding, or having certain other medical conditions such as cancer, hepatitis B or C or HIV. Also, CIDP patients that do not respond to or are sensitive to treatment with intravenous immunoglobulin cannot participate. Participants should not have received other immuno-modulating treatments other than low-dose steroids within the six weeks before the trial.

What happens during the trial?

Participants will receive either subcutaneous immunoglobulin or a placebo (an inactive substance indistinguishable from the active drug) twice or three times a week for 98 days. Their muscle strength will be measured on day 14, 28, 84 and 98. Participants will also be requested to keep a diary to evaluate the feasibility of the study and if they prefer to receive the subcutaneous treatment at home or the regular intravenous injections at the hospital.

Where is the study taking place?

Aarhus University Hospital
Noerrebrogade, Department of Neurology
Aarhus, Denmark, 8000

In most circumstances, for somebody to participate in a clinical trial, they need to live near the team of people who are conducting the research, because they need to be closely monitored.

How could the results of the trial benefit patients?

The results from this trial will start to gather the first evidence as to whether treating CIDP patients with subcutaneous immunoglobulin is feasible and as effective as the standard intravenous treatment. If this treatment does prove to be effective, it would be an important alternative to the standard treatment, with the advantage of being administered at home instead of requiring hospital admission. Also, side effects are expected to be less.

Contact Details:

Professor, MD, Johannes Jakobsen

Who is funding this study?

  • University of Aarhus, Aarhus, Denmark
  • Baxter Healthcare Corporation
  • GCP Unit at Aarhus University Hospital, Aarhus, Denmark

Official name of the Trial:

Randomized, Double-blinded, Placebo-controlled Trial of Subcutaneous Immunoglobulin Treatment in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).

Trial study number:

NCT01017159

Further trial details:

For further information on the trial and detailed inclusion and exclusion please click on the link below. Sometimes these details can be quite technical. If you have any questions please discuss this with your clinician or contact the clinical trial organisers.

http://clinicaltrials.gov/ct2/show/NCT01017159?term=NCT01017159&rank=1

Background information and related links:

This phase 2 study aims to test whether subcutaneous immunoglobulin treatment is effective for chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

CIDP is an autoimmune disorder – a condition in which the body directs an immune response towards itself instead of foreign materials. In CIDP this response is directed towards the myelin, a fatty substance that covers nerve fibres and allows the communication between nerves and muscles. This causes muscle weakness, numbness, pain and difficulty in walking.

To date, there is no cure for CIDP, but there are effective immunosuppressive therapies available to alleviate the symptoms and improve quality of life. One of the treatments used for CIDP patients is injecting immunoglobulins directly into the blood stream (intravenous). Immunoglobulins are also called antibodies and when they are given to patients with autoimmune conditions they help to shut down the abnormal autoimmune response. However, the administration of intravenous immunoglobulin requires regular and frequent hospital admissions and is often accompanied by unpleasant side effects causing discomfort to the patients.

In this trial the immunoglobulin treatment will be administered under the skin (subcutaneously) without requiring hospital admission. This study aims to find out if injecting immunoglobulins under the skin is as effective as injecting it into the blood stream.

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