BIOMARK: Biomark Study: Predict Intravenous Immunoglobulin Responders in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Suspended

CT.gov ID

NCT02629796

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

2.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
CIDP	Other: CIDP treated (IVIG)

Study Design

Study Type:

Observational

Actual Enrollment :

44 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Biomarker to Predict the Response to Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients: a Transcriptomic Study

Actual Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
CIDP treated (IVIG) patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) according to European criteria, treated with IVIG (intravenous immunoglobulin as a first line of treatment) as a usual treatment	Other: CIDP treated (IVIG) usual treatment with intravenous immunoglobulin
control healthy subjects

Arm

Intervention/Treatment

CIDP treated (IVIG)

patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) according to European criteria, treated with IVIG (intravenous immunoglobulin as a first line of treatment) as a usual treatment

Other: CIDP treated (IVIG)

usual treatment with intravenous immunoglobulin

control

healthy subjects

Outcome Measures

Primary Outcome Measures

blood-levels of biomarkers of Intravenous immunoglobulin response [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Bordeaux, service de Neurologie	Bordeaux	Aquitaine	France	33000
2	CHU Henri Mondor	Créteil	Ile De France	France	94000
3	CHU Nantes, Laboratoire d'explorations fonctionnelles	Nantes	Loire Atlantique	France	44000
4	CHU de Brest	Brest		France	29609
5	CHU de CAEN	Caen		France	14000
6	Service de Neurologie Hopital du Kremlin Bicêtre	Le Kremlin-Bicêtre		France	94270
7	CHRU Lille	Lille		France	59000
8	Service de Neurologie, CHU Limoges,	Limoges		France	87042
9	Hôpital Neurologique HCL, Lyon-Bron	Lyon		France	69677
10	CHU de NIMES	Nimes		France	30900
11	Service de Physiologie Clinique - Explorations Fonctionnelles, Hôpital Lariboisière	Paris		France	75010
12	Service de Neurologie, Fondation Ophtalmologique Adolphe de Rothschild	Paris		France	75019
13	Centre Hospitalier Intercommunal de Poissy/Saint-Germain-en-Laye	Poissy		France	78303
14	CHU de Poitiers	Poitiers		France	86021
15	CHU de ROUEN	Rouen		France	76000
16	Centre Hospitalier de Saint-Denis	Saint-Denis		France	93205
17	Service de Neurologie CHU St Etienne	Saint-Etienne		France	42055
18	Service de Neurologie, CHU de Strasbourg	Strasbourg		France	67098