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Defining treatment response in patient with CIDP, shifting from statistics to bedside

Defining treatment response in patient with CIDP, shifting from statistics to bedside - MCID in CIDP

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48408
Enrollment
120
Registered
2019-06-04
Start date
2019-09-03
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Chronic Inflammatory Demyelinating Polyneuropathy CIDP

Interventions

None listed

Sponsors

Amsterdam UMC, locatie AMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Possible, probable or definite clinical and electrophysiological EFNS/PNS criteria for CIDP (Group 1 and 2).5 In addition: A) Patients in Group 1 need to have active disease (history of progression justifying start or change of treatment as determined by treating physician). B) Patients in Group 2 with stable disease for three months on treatment with IVIg and/or corticosteroids. OR have a polyneuropathy associated with monoclonal IgM paraproteinemia (with or without anti-MAG antibodies) (Group 3, controls). - Adult males or females (18 year or more).

Exclusion criteria

Exclusion criteria: - Any concomitant disease (e.g. joint problems) or condition (e.g. misuse of alcohol) that might interfere with functionality of the patient, which could potentially interfere with capturing MCID changes related predominantly to CIDP. - Legally incompetent adults - No informed consent

Design outcomes

Primary

MeasureTime frame
To define treatment response in CIDP using patient pMCID versus traditional MCID cut-offs on a linear disability scale.

Secondary

MeasureTime frame
1) To determine whether pMCID during improvement is larger than the pMCID during deterioration. 2) To determine the margins of score fluctuation on the I-RODS during follow-up in patients with stable disease.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)