Skip to content

T-cell clonal expansion in chronic demyelinating inflammatory polyradiculoneuropathy (CIDP)

T-cell clonal expansion in chronic demyelinating inflammatory polyradiculoneuropathy (CIDP) - TEC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37266
Enrollment
10
Registered
2013-01-22
Start date
2013-03-20
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

chronic demyelinating inflammatory polyradiculoneuropathy (CIDP) no lay term

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1 - Adult patients (> 18 years) - Fulfilment of the EFNS/PNS criteria for probable or definite CIDP - Clinical sensory deficit corresponding with sural nerve in one or both legs AND absent sensory nerve action potential (SNAP) on nerve conduction studies. Group 2 - Adult patients (> 18 years) - Fulfilment of the EFNS/PNS criteria for probable or definite CIDP - Patients with intravenous immunoglobulin (IVIg) maintenance treatment who are eligible for IVIg withdrawal to confirm IVIg dependency - No fluctuation of clinical condition or dose of IVIg in the last 3 months

Exclusion criteria

Exclusion criteria: - Other diseases known to cause neuropathy - Use of drugs which are known to cause neuropathy - Use of immunomodulatory drugs in the last 3 months - Refusal to give informed consent or withdrawal of previously given permission - Legally incompetent adult

Design outcomes

Primary

MeasureTime frame
1) Frequency and overlap of expanded T-cell clones in sural nerve biopsies and peripheral blood in patients with active disease (Group 1). 2) Change in frequency of expanded clones in blood a) comparing active disease with stable disease (Group 1) b) comparing stable disease during IVIg maintenance treatment and active disease after stopping treatment (Group 2).

Secondary

MeasureTime frame
1. MRC sum score 2. INCAT sensory sum score 3. INCAT disability scale 4. Sural nerve biopsy questionnaire (applicable only for Group 1)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)