Extension study of maintenance treatment with subcutaneous immunoglobulin (IgPro20) for chronic inflammatory demyelinating polyneuropathy (CIDP)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

- Subjects having participated in the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076).
- Written informed consent for study participation obtained before undergoing any study-specific procedures.
- If treatment for CIDP is required, it has to include IgGs.
- Subjects who completed study IgPro20_3003 before study IgPro20_3004 study was open for enrollment at the site must be enrolled no later than 8 weeks after study IgPro20_3004 is open for enrollment at the site.
- Subjects who completed study IgPro20_3003 after study IgPro20_3004 study was open for enrollment at the site must be enrolled no later than 8 weeks after the completion visit of study IgPro20_3003

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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Subjects unable to directly transition from study IgPro20_3003.
- New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse) during participation in study IgPro20_3003 that in the judgment of the investigator could increase risk to the subject, interfere with the evaluation of IMP, and/or conduct of the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate long-term safety of IgPro20.;Secondary Objective: - To evaluate the long-term safety of IgPro20 by dose <br>- To evaluate the efficacy of IgPro20.;Primary end point(s): Overall Rate of adverse events (AEs) per infusion;Timepoint(s) of evaluation of this end point: Up to 49 weeks<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Rate of adverse events (AEs) per infusion by severity, causality and seriousness<br>- Percentage of subjects with AEs, overall and by severity, causality and seriousness<br>- Rate of adverse events (AEs) per infusion by severity, causality and seriousness by IgPro 20 dose level<br>- Percentage of subjects with adverse events (AEs) by severity, causality and seriousness by IgPro20 dose level<br>- Changes from baseline in total adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) score<br>- Change from baseline in Medical Research Council (MRC) score<br>- Change from baseline in Rasch-built Overall Disability Scale (R-ODS)<br>- Change from baseline in mean grip strenght<br>- Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. Relapse is defined as an increase of at leaset 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score only).;Timepoint(s) of evaluation of this end point: Up to 49 weeks

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