Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Study of CIDP Patients During IVIG Treatment

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00305266
First received: March 20, 2006
Last updated: November 30, 2007
Last verified: November 2007
History of Changes
  Purpose

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.

Hypothesis:

  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 Intervention
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
 Drug: intravenous gammaglobulin

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: "Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy"

Resource links provided by NLM:

Drug Information available for: Rhophylac
U.S. FDA Resources

Further study details as provided by University of Aarhus:
Enrollment: 11
Study Start Date: August 2005
Study Completion Date: August 2007
Intervention Details:
    Drug: intravenous gammaglobulin
    individual dose
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.

Objective:

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.
  Eligibility
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305266

Locations
Denmark
Aarhus University Hospital, Department of Neurology
Aarhus, Denmark
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Henning Andersen, MD Aarhus University Hospital
Study Chair: Johannes Jakobsen, professor Aarhus University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00305266     History of Changes
Other Study ID Numbers: 2005-0018  EudraCT nr.: 2004-004357-26 
Study First Received: March 20, 2006
Last Updated: November 30, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
CIDP
IVIG
gammaglobulin
Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Additional relevant MeSH terms:
Polyradiculoneuropathy
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Autoimmune Diseases
Immune System Diseases
Gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016