Subcutaneous versus intravenous administration of immunoglobulin in newly diagnosed patients with chronic inflammatory neuropathy

Phase 1

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 21.1Level: PTClassification code 10064135Term: Polyneuropathy chronicSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2018-003592-34-DK

Lead Sponsor: Aarhus University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients diagnosed with typical or pure motor CIDP fulfilling the European Federation of Neurological Societies / Peripheral Nerve Society (EFNS/PNS) clinical and elctrophysiological criteria for definite or propable CIDP
Age > 18 and <80 years at inclusion
Overall disability sum score (ODSS) > 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Previous treatment with immmunoglobulin
Pregnancy
Malignancies
Other causes of neuropathy (Diabetes Mellitus)
Severe medical diseases
Other immunomodulating treatment in the last 6 weeks prior to inclusion
Hepatitis B and C or HIV
Lactation

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of SCIG versus IVIG in de-novo CIDP patients during a treatment period of 26 weeks (phase I);Secondary Objective: To evaluate a standardized reduction of dosage regimen to identify the lowest effective dosage of immunoglobulin (phase II).;Primary end point(s): Change in Overall Disability Sum score (ODSS) measured by questionnaire from baseline until end of phase I (26 weeks)<br><br>Change in Overall Disability Sum score (ODSS) measured by questionnaire from start of phase II and until the lovest effective dosage of immunoglobulin has been reached (up til 60 weeks);Timepoint(s) of evaluation of this end point: Phase I: <br>All patients will be evaluated at baseline (week 0) and re-evaluated at week 2, 4, 14, 20 and 26<br><br>Phase II:<br>All patients will be evaluated every 12th week according to lovering of the dosage of immunoglobulin<br>

Secondary Outcome Measures