T-cell response in CIDP, a biomarker study

T-cell response in CIDP, a biomarker study - Biomarkers in CIDP

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40737

Enrollment

Registered

2014-06-11

Start date

2014-08-12

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

CIDP inflammatory neuropathy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Lack of informed consent of the subject.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results