Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingNCT00305266
Study of CIDP Patients During IVIG Treatment
An observational study of Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- What is being tested?
- intravenous gammaglobulin
- Type of treatment
- Injection or infusion
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2005to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Motor and sensory dysfunction involving more than one limb.
- Electrodiagnostic study with signs of demyelination
Who cannot join
- Prior systemic allergic reaction to IVIG
- Severe systemic disease
- Other conditions associated with neuropathy (eg diabetes, lack of vitamin- B12)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy"
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:
- During continues treatment of IVIG at regular intervals of 3-10 weeks.
- During pause in treatment.
Read more
Hypothesis:
- The disease activity in the patients are cyclical correlating to the treatment intervals.
- 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.
Read the 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:
- Recruitment of immune cells to the affected tissue by chemoattraction. (Chemokine receptors on mononuclear cells)
- 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)
- Synthesis of mRNA and secretion of regulatory cytokines.
- Being tested
- intravenous gammaglobulin
- Keywords
- CIDP, IVIG, gammaglobulin, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous gammaglobulinDrug
individual dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2006 (estimated)
- Study startAug 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Henning Andersen, MD, Principal investigator, Aarhus University HospitalJohannes Jakobsen, professor, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305266
- Sponsor's protocol ID
- 2005-0018
- Other IDs
- EudraCT nr.: 2004-004357-26
- Status last verified
- Nov 2007
- First submitted
- 20 Mar 2006
- Last updated
- 3 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Clinical Study of Intravenous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy"
- ClinicalTrials.gov ID
- NCT00305266
- Acronym / sponsor ID
- 2005-0018
- Keywords
- CIDP, IVIG, gammaglobulin, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- During continues treatment of IVIG at regular intervals of 3-10 weeks.
- During pause in treatment.
Hypothesis:
- The disease activity in the patients are cyclical correlating to the treatment intervals.
- 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 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:
- Recruitment of immune cells to the affected tissue by chemoattraction. (Chemokine receptors on mononuclear cells)
- 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)
- Synthesis of mRNA and secretion of regulatory cytokines.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Motor and sensory dysfunction involving more than one limb.
- Electrodiagnostic study with signs of demyelination
Key exclusion criteria (4 listed)
- Prior systemic allergic reaction to IVIG
- Severe systemic disease
- Other conditions associated with neuropathy (eg diabetes, lack of vitamin- B12)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous gammaglobulinindividual dose | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Andersen, MD principal investigator
Aarhus University Hospital
Johannes Jakobsen, professor study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2007.