Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305266
Status:
COMPLETED
Last Update Posted:
2007-12-03
First Post:
2006-03-20
Brief Title:
Study of CIDP Patients During IVIG Treatment
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to quantify the effect of IVIG treatment in a group of patients with chronic inflammatory demyelinating polyradiculoneuropathyCIDP 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
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
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 therapySeveral 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 Scorethe 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 laminaAdhesion molecules on mononuclear cells and soluble in plasma metalloproteinases
3 Synthesis of mRNA and secretion of regulatory cytokines
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 Scorethe 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 laminaAdhesion molecules on mononuclear cells and soluble in plasma metalloproteinases
3 Synthesis of mRNA and secretion of regulatory cytokines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT nr 2004-004357-26 | None | None | None |