Predicting decline in CIDP patients during IVIg treatment adaptation
ActiCIDP : Exploratory Study on the Feasibility of Predicting CIDP Patients' Evolution Decline During Intravenous Immunoglobulins Treatment Adaptation.
This study is trying to see if we can predict when people with CIDP might get worse during their IVIg treatment by monitoring their health and daily movements over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Liege Academic / other |
| Locations | 1 site (Liège, Liège) |
| Trial ID | NCT06183645 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of predicting declines in patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) during their treatment with intravenous immunoglobulin (IVIg). Approximately 40 patients will be monitored over a year, with assessments every three months. Participants will undergo clinical examinations and various functional tests, while wearing an innovative device called Actimyo to track their daily movements. The data collected will help understand the relationship between treatment adaptation and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with CIDP who are clinically stable and receiving IVIg treatment.
Not a fit: Patients with significant cognitive disorders, non-ambulant status, or other autoimmune diseases requiring corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for CIDP patients undergoing IVIg treatment.
How similar studies have performed: While similar studies have explored monitoring techniques in CIDP, the specific use of the Actimyo device for this purpose is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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 autoimmune disease that requires Corticosteroids, IVIg, Plasma Exchange treatment * Pregnancy or breastfeeding * Any other condition that, according to the investigator, could significantly interfere with patient evaluation or safety.
Where this trial is running
Liège, Liège
- CHR Citadelle — Liège, Liège, Belgium (Recruiting)
Study contacts
- Principal investigator: Margaux Poleur, Dr — CHR Citadelle
- Study coordinator: Laurie Medard
- Email: laurie.medard@citadelle.be
- Phone: 043215584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.