Clinical trial NCT02629796: Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Official title: Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CIDP
Keywords: Biomarker
CIDP
IVIG
treatment response
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-12-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic inflammatory demyelinating polyradiculoneuropathy. Transcriptome, metabolome and proteome analysis compared with those of healthy subjects

Brief summary: This study aims analyze the transcriptome to identify predictive biomarkers of IVIG in CIDP patients. 25 patients with a diagnosis of CIDP according to European criteria, naïve of treatment, will be included and followed for 1 year. Clinical assessment (RT-MRC ; Martin vigorimeter, RT-mISS,R-ODS,TW25, 9hole-peg test) will be performed at baseline and at 3, 6 and 12 months after the first IVIG course. Responder/No responder status will be defined at 3 month and confirmed at 12 months. Blood samples will be collected before the IVIG course at baseline, and at 2months and 6 months. At the end of the first IVIG course a blood sample will be collected to assess early changes of transcriptome. The CIDP diagnosis and responder/no responder status will be confirmed by an independent committee. The transcriptome of the patients will be individually analyzed and compared regarding Responder/Non responder status to a control groups of 20 healthy subjects


Eligibility criteria: Inclusion Criteria:

* chronic inflammatory demyelinating polyradiculoneuropathy (according to european criterions)
* first line of treatment
* treatment with intravenous immunoglobulin required
* healthy subjects matched for age and gender

Exclusion Criteria:

For CIDP patients

* uncontrolled diabetes, monoclonal spike with anti-ganglioside activity, anti myelin-associated glycoprotein antibodies, HIV infection, HBV infection, HCV infection, connective tissue disease, hemopathy, evolutive disease)

For healthy subjects:

any chronic or autoimmune disease

For all subjets viral or bacterial infection in the last 30 days chemotherapy in the last 5 years immunosuppressive therapy

Primary outcomes:
measure: blood-levels of biomarkers of Intravenous immunoglobulin response
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux, service de Neurologie
state: Aquitaine
city: Créteil
country: France
facility: CHU Henri Mondor
state: Ile De France
city: Nantes
country: France
facility: CHU Nantes, Laboratoire d'explorations fonctionnelles
state: Loire Atlantique
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de CAEN
city: Le Kremlin-Bicêtre
country: France
facility: Service de Neurologie Hopital du Kremlin Bicêtre
city: Lille
country: France
facility: CHRU Lille
city: Limoges
country: France
facility: Service de Neurologie, CHU Limoges,
city: Lyon
country: France
facility: Hôpital Neurologique HCL, Lyon-Bron
city: Nimes
country: France
facility: CHU de NIMES
city: Paris
country: France
facility: Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière
city: Paris
country: France
facility: Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild
city: Poissy
country: France
facility: Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: CHU de ROUEN
city: Saint-Denis
country: France
facility: Centre Hospitalier de Saint-Denis
city: Saint-Etienne
country: France
facility: Service de Neurologie CHU St Etienne
city: Strasbourg
country: France
facility: Service de Neurologie, CHU de Strasbourg
Study officials:
References: