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| Descriptive Information Fields | |||||||||
| Brief Title † | Study of CIDP Patients During IVIG Treatment | ||||||||
| Official Title † | "Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy" | ||||||||
| 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:
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. |
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| 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:
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| Study Phase | |||||||||
| Study Type † | Observational | ||||||||
| Study Design † | Prospective | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | ||||||||
| Intervention † | Drug: intravenous gammaglobulin | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | 11 | ||||||||
| Start Date † | August 2005 | ||||||||
| Completion Date | August 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | Denmark | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00305266 | ||||||||
| Organization ID | 2005-0018 | ||||||||
| Secondary IDs †† | EudraCT nr.: 2004-004357-26 | ||||||||
| Study Sponsor † | University of Aarhus | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of Aarhus | ||||||||
| Verification Date | November 2007 | ||||||||
| First Received Date † | March 20, 2006 | ||||||||
| Last Updated Date | November 30, 2007 | ||||||||