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CompletedNCT00305266Updated Dec 3, 2007

Study of CIDP Patients During IVIG Treatment

An observational study in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-12-03.

Sponsored by University of Aarhus · Observational

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Study type
Observational
Time perspective
Prospective
Enrollment
11
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark — 8 open to participants now, 11 under way, 6 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Denmark.

Started
2005
the only one that year
Observational
7 of 24
1 open now
Registered
1st of 24
by date
Lead sponsor
6 of 24
University of Aarhus

Among the 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark, this one is the only one that started in 2005, is one of 7 observational ones, and was the 1st registered.

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Open to participants now

8 of the 24 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Denmark are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

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02

Study 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. 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.

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:

  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.
03

Conditions studied

  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Keywords

  • CIDP
  • IVIG
  • gammaglobulin
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Motor and sensory dysfunction involving more than one limb.
  • Electrodiagnostic study with signs of demyelination

Exclusion criteria

Exclusion Criteria:

  • Prior systemic allergic reaction to IVIG
  • Severe systemic disease
  • Other conditions associated with neuropathy (eg diabetes, lack of vitamin- B12)
  • Pregnancy
05

Study design

Time perspective
Prospective
Enrollment
11 participants (actual)

Interventions

  • Drugintravenous gammaglobulin

    individual dose

06

Study locations

1 site
  • Aarhus University Hospital, Department of Neurology
    Aarhus, Denmark
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2005 and a completion of Aug 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2006
First posted
Mar 21, 2006
Start
Aug 2005
CompletionActual
Aug 2007
Last update
Dec 3, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00305266
First posted
Mar 21, 2006
Start date
Aug 2005
Completion
Aug 2007
Last update
Dec 3, 2007

Study contacts

Henning Andersen, MD
principal investigator · Aarhus University Hospital
Johannes Jakobsen, professor
study chair · Aarhus University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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