ClinicalTrials.gg
RecruitingNCT06183645ActiCIDPUpdated Feb 12, 2025

Exploratory Study on Predicting CIDP Patients' Decline During IV Immunoglobulin Treatment Adaptation Feasibility.

An observational study in Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Centre Hospitalier Universitaire de Liege. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-12.

Sponsored by Centre Hospitalier Universitaire de Liege · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Belgium — 4 open to participants now, 6 under way, 3 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Belgium.

Started
2023
the only one that year
Observational
Only one
of the 15
Registered
10th of 15
by date
Lead sponsor
1 of 15
Centre Hospitalier Universitaire de Liege

Among the 15 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Belgium, this one is the only one that started in 2023, is the only observational one, and was the 10th 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

4 of the 15 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in Belgium are open now. Recruiting first, the newest first:

All 4 open studies →

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

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 99 Years · all sexes · no healthy volunteers.

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02

Study summary

ActiCIDP is a monocentric academic study. Patients with Chronic inflammatory demyelinating polyradiculoneuritis may be included on a voluntary basis.

The investigators plan to include a group of approximately 40 patients with CIDP.

The investigators have planned to assess patient every three months for a year. After each visit, participants will wear Actimyo for one month daily.

Read the detailed description

On each visit, participants will undergo a clinical examination with MRC sum score, a mISS score and a I-RODS score.

They will perform few tests 6-minutes walk test (6MWT), a myogrip measurement, and a 9 Hole Peg Test (9HPT) and will answer to some questionaires (mISS, INCAT and PGIC).

Actimyo is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.

03

Conditions studied

  • Chronic Inflammatory Demyelinating Polyneuropathy

Keywords

  • Actimyo
  • Accelerometry
  • Daily living
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults patients with Chronic inflammatory demyelinating polyradiculoneuritis

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

  • Diagnosed with CIDP or possible CIDP based on 2021 EAN/PNS criteria2.
  • Treated with IVIg (≤1g/kg/3-8week)
  • Clinically Stable disease for 3 months (according to treating physician opinion).
  • No treatment withdrawal failure within 1 year
  • Age over 18 years

Exclusion criteria

Exclusion Criteria:

  • Significant cognitive or communication disorders
  • Surgery or serious traumatic injury ≤ 6 months
  • Non ambulant patient
  • Current participation to a therapeutic trial
  • Anti-myeline antibodies (anti-MAG) positive or nodo-paranodopathy
  • Other disease that requires , IVIg, Plasma Exchange treatment
  • Pregnancy or breastfeeding
  • Any other condition that, according to the investigator, could significantly interfere with patient evaluation or safety.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • DeviceActimyo

    Participants will wear 2 Actimyos in everyday life. Actimyo is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.

06

What researchers measure

Primary outcomes

  1. 95th centile of stride velocity

    95th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).

    Time frame: 1 year

  2. 50th centile of stride velocity

    50th centile of stride velocity obtained with a magneto-inertial sensor (Actimyo) in real-life (meter per second).

    Time frame: 1 year

  3. 95th centile of stride length

    95th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).

    Time frame: 1 year

  4. 50th centile of stride length

    50th centile of stride length obtained with a magneto-inertial sensor (Actimyo) in real-life (meter).

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Jan 2028, 53 months after the start.

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

Registered
Dec 14, 2023
First posted
Dec 27, 2023
StartActual
Aug 28, 2023
Primary completionEst.
Jan 2028
CompletionEst.
Jan 2028
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
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 Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06183645
Lead sponsor
Centre Hospitalier Universitaire de Liege
Collaborators
SYSNAV, Centre Hospitalier Régional de la Citadelle
Responsible party
Stéphanie DELSTANCHE (Coordinator of reference center for neuromuscular diseases, Centre Hospitalier Universitaire de Liege) — Principal investigator
First posted
Dec 27, 2023
Start date
Aug 28, 2023
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Feb 12, 2025

Study contacts

Laurie Medard
Contact
laurie.medard@citadelle.be
043215584 ext. +32
Margaux Poleur, Dr
Contact
margaux.poleur@citadelle.be
04216127 ext. +32
Margaux Poleur, Dr
principal investigator · CHR Citadelle

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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