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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02629796

Acronym

BIOMARK

Enrollment

Registered

2015-12-14

Start date

2014-04-16

Completion date

2021-11-15

Last updated

2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CIDP

Keywords

Biomarker, CIDP, IVIG, treatment response

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

Interventions

OTHERCIDP treated (IVIG)

usual treatment with intravenous immunoglobulin

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
blood-levels of biomarkers of Intravenous immunoglobulin response	8 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026