Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20)

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
MedDRA version: 14.1Level: PTClassification code 10061811Term: Demyelinating polyneuropathySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-003448-28-AT

Lead Sponsor: CSL Behring GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

1. Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
2. Repeated treatment with IVIG (= 4 infusions) within the last 9 months prior to enrollment.
3. An IVIG treatment during the last 8 weeks prior to enrollment.
4. Age =18 years.
5. Written informed consent for study participation obtained before undergoing any study-specific procedures.
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 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

1. Any polyneuropathy of other causes
2. Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
3. Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
4. History of thrombotic episodes within the 2 years prior to enrolment
5. Known allergic or other severe reactions to blood products including intolerability to previous IVIG

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placebo.;Secondary Objective: - To investigate the efficacy of IgPro20 with additional clinical outcome measures in comparison to placebo.<br>- To investigate the safety and tolerability of IgPro20 in comparison to placebo.<br>- To investigate health-related quality of life (HRQL) following treatment with IgPro20.;Primary end point(s): Percentage (%) of subjects who relapse during the SC treatment period;Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change in mean Inflammatory Neuropathy Cause and Treatment (INCAT) scores during the SC treatment period <br>2. Change in mean maximum grip strength scores during the SC treatment period <br>3. Change in mean Medical Research Council (MRC) sum scores during the SC treatment period <br>4. Change in mean Rasch-built Overall Disability Scale (R-ODS) scores during the SC treatment period <br>5. Time to CIDP relapse<br>6. Rate of adverse events per SC infusion<br>7. Number of subjects with adverse events during the SC Treatment Period<br>8. Percentage of subjects with adverse events during the SC Treatment Period;Timepoint(s) of evaluation of this end point: 1. - 4. SC week 1, SC week 25<br>5. up to 24 weeks<br>6. - 8. 24 weeks