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Sponsored by: |
University of Aarhus |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00305266 |
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:
Hypothesis:
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 |
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Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
Drug: intravenous gammaglobulin |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | "Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy" |
Enrollment: | 11 |
Study Start Date: | August 2005 |
Study Completion Date: | August 2007 |
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:
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Aarhus University Hospital, Department of Neurology | |
Aarhus, Denmark |
Principal Investigator: | Henning Andersen, MD | Aarhus University Hospital |
Study Chair: | Johannes Jakobsen, professor | Aarhus University Hospital |
Study ID Numbers: | 2005-0018, EudraCT nr.: 2004-004357-26 |
Study First Received: | March 20, 2006 |
Last Updated: | November 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00305266 |
Health Authority: | Denmark: Danish Medicines Agency |
CIDP IVIG gammaglobulin Chronic Inflammatory Demyelinating Polyradiculoneuropathy |
Gamma-Globulins Autoimmune Diseases Demyelinating Diseases Polyradiculoneuropathy Polyneuropathies Demyelinating diseases Chronic inflammatory demyelinating polyneuropathy Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
Antibodies Neuromuscular Diseases Immunoglobulins, Intravenous Peripheral Nervous System Diseases Rho(D) Immune Globulin Autoimmune Diseases of the Nervous System Immunoglobulins |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |