Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Study of CIDP Patients During IVIG Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00305266
Recruitment Status : Completed
First Posted : March 21, 2006
Last Update Posted : December 3, 2007
Information provided by:
University of Aarhus

Brief Summary:

The aim of this study is to quantify the effect of IVIG treatment in a group of patients with chronic inflammatory demyelinating polyradiculoneuropathy(CIDP), who requires continues treatment of IVIG at regular intervals of 3-10 weeks:

  1. During continues treatment of IVIG at regular intervals of 3-10 weeks.
  2. During pause in treatment.


  1. The disease activity in the patients are cyclical correlating to the treatment intervals.
  2. Pause in treatment will increase disease activity, which can be quantified with symptom scores, disability scales, and clinical test.

Primary effect parameter is muscle strength quantified by isokinetic dynamometry.

Added to the protocol there is an immunological study of inflammatory markers in blood samples of patients under treatment pause.

Condition or disease Intervention/treatment
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Drug: intravenous gammaglobulin

Detailed Description:

Background: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare autoimmune disease of the peripheral nervous system characterized by demyelination of the nerves, which causes muscle weakness and sensory loss. Treatment is immune modulating, and intravenous immunoglobulin (IVIG) is first line therapy.Several trials have demonstrated effect on motor function by the initial treatment, but the effect of consecutive IVIG treatment is only sporadic described in the literature.

It is a clinical study including present CIDP patients in treatment at the University Hospital of Aarhus. The patients will be evaluated several times before and after IVIG treatment, to describe the effect profile.

The primary effect parameter is muscle strength quantified by isokinetic dynamometry at ankle knee, hip, wrist, elbow and shoulder. That is a sensitive method of measuring the strength of the larger muscle groups, correlating with symptoms and signs of neuropathy.

Severity of neuropathy among the patients will also be described applying nerve conduction studies, quantitative sensory testing of threshold for detecting vibration and cold at upper and lower limbs, the Neuropathy Disability Scale, the Neuropathy Symptom Score,the overall disability sum score, 9 hole peg test, walking test, and the Short-form 36 health questionnaire.

Added to the protocol there is an immunological study of inflammatory markers in blood samples of patients under treatment pause.


With this study we will describe some important aspects in the immune response causing the inflammatory lesions in CIDP and MMN, including:

  1. Recruitment of immune cells to the affected tissue by chemoattraction. (Chemokine receptors on mononuclear cells)
  2. Crossing the blood-nerve barrier: interactions and adhesion between the lymphocyte and endothelial cell, transendothelial diapedesis and enzymatic degeneration of the basal lamina.(Adhesion molecules on mononuclear cells and soluble in plasma, metalloproteinases)
  3. Synthesis of mRNA and secretion of regulatory cytokines.

Layout table for study information
Study Type : Observational
Actual Enrollment : 11 participants
Time Perspective: Prospective
Official Title: "Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy"
Study Start Date : August 2005
Actual Study Completion Date : August 2007

Intervention Details:
  • Drug: intravenous gammaglobulin
    individual dose

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Motor and sensory dysfunction involving more than one limb.
  • Electrodiagnostic study with signs of demyelination

Exclusion Criteria:

  • Prior systemic allergic reaction to IVIG
  • Severe systemic disease
  • Other conditions associated with neuropathy (eg diabetes, lack of vitamin- B12)
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00305266

Layout table for location information
Aarhus University Hospital, Department of Neurology
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
Layout table for investigator information
Principal Investigator: Henning Andersen, MD Aarhus University Hospital
Study Chair: Johannes Jakobsen, professor Aarhus University Hospital
Layout table for additonal information Identifier: NCT00305266    
Other Study ID Numbers: 2005-0018
EudraCT nr.: 2004-004357-26
First Posted: March 21, 2006    Key Record Dates
Last Update Posted: December 3, 2007
Last Verified: November 2007
Keywords provided by University of Aarhus:
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Additional relevant MeSH terms:
Layout table for MeSH terms
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs