T-cell response in CIDP, a biomarker study

Completed

• Conditions: CIDP; inflammatory neuropathy; 10034606

• Registration Number: NL-OMON40737
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

- Newly diagnosed untreated patients who fulfill the clinical and electrophysiological EFNS/PNS criteria for CIDP OR
- Patients diagnosed with CIDP according to the clinical and electrophysiological EFNS/PNS criteria for CIDP with maintenance IVIg treatment (> 6 months of treatment) OR
- Patients diagnosed with CIDP according to the clinical and electrophysiological EFNS/PNS criteria for CIDP with a stable clinical condition without treatment in the last 12 months.
- Adult males or females (18 year or more)

Exclusion Criteria

Lack of informed consent of the subject.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>(1) the percentage of the total TCR repertoire representing dominantly expanded<br /><br>T-cell clones,<br /><br>(2) the number of circulating lymphocytes subsets and monocytes,<br /><br>(3) the number of cell divisions during T-cell supression assays.<br /><br>These paramters will be compared between groups of patients with active disease<br /><br>and patients without active disease. In individual patients these parameters<br /><br>will be compared during different states of disease activity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>